Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid

K260312 · Gmp Medicare Sdn. Bhd. · LZA · Sep 8, 2026 · General Hospital

Device Facts

• Record ID: K260312
• Device Name: Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid
• Applicant: Gmp Medicare Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Sep 8, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, ambidextrous nitrile patient examination gloves; available in blue or violet blue. Designed to prevent cross-contamination between patient and examiner in healthcare facilities. Blue variant includes 5-year shelf-life claim; violet blue variant incorporates Dioxazine Violet colorant. Both variants tested for permeation resistance against 32 chemotherapy drugs, fentanyl citrate, xylazine, and gastric acid per ASTM D6978-05. Healthcare professionals wear gloves during patient examinations or handling of hazardous substances. Output is a physical barrier; protects the wearer from chemical exposure and prevents patient contamination. Benefits include barrier protection against specific chemotherapy agents and other substances.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including physical property testing (tensile strength, elongation), barrier integrity (pinhole testing), biocompatibility (skin irritation, sensitization, acute systemic toxicity), and chemical permeation resistance per ASTM D6978-05.

Technological Characteristics

Nitrile material; powder-free; ambidextrous; non-sterile; single-use. Dimensions and physical properties conform to ASTM D6319-19(2023). Barrier integrity per ASTM D5151-19(2023). Residual powder per ASTM D6124-06(2022). Biocompatibility per ISO 10993-10, -11, -23. Violet blue variant uses Dioxazine Violet (CAS 6358-30-1) colorant.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for permeation resistance against 32 chemotherapy drugs, fentanyl citrate, xylazine, and gastric acid. Warning: Do not use with Carmustine and Thiotepa.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim (K202003)

Submission Summary (Full Text)

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**U.S. FOOD & DRUG**
ADMINISTRATION

September 8, 2026

Gmp Medicare Sdn. Bhd.
Ummi Salmah Othman
Regulatory Affairs Assistant Manager
Lot/Pt 64593, Jalan Dahlia/Ku8,
Kawasan Perindustrian Meru Timur
Klang, Selangor 41050
Malaysia

Re: K260312

Trade/Device Name: Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid

Regulation Number: 21 CFR 880.6250

Regulation Name: Non-Powdered Patient Examination Glove

Regulatory Class: Class I, reserved

Product Code: LZA, LZC, OPJ, QDO

Dated: August 11, 2026

Received: August 11, 2026

Dear Ummi Salmah Othman:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K260312 - Ummi Salmah Othman

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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K260312 - Ummi Salmah Othman

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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

ALLAN GUAN -S

For Bifeng Qian, M.D., Ph.D.

Assistant Director

DHT4C: Division of Infection

Control Devices

OHT4: Office of Surgical and

Infection Control Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120

Expiration Date: 07/31/2026

See PRA Statement below.

510(k) Number (if known)

K260312

Device Name

Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance
Claim Glove

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 standard practice for assessment of medical gloves to permeation by chemotherapy drugs:

Chemotherapy Drug Permeation

The following chemicals have been tested with these gloves.

| Chemotherapy Drugs | Concentration | Breakthrough Detection Time in Minutes |
| --- | --- | --- |
| Amethopterin | 25.0 mg/ml | > 240 |
| Bleomycin Sulfate | 15.0 mg/ml | > 240 |
| Busulfan | 6.0 mg/ml | > 240 |
| Carboplatin | 10.0 mg/ml | > 240 |
| Carmustine (BCNU) | 3.3 mg/ml | 11.0 |
| Cisplatin | 1.0 mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | > 240 |
| Cytarabine | 100.0mg/ml | > 240 |
| Dacarbazine (DTIC) | 10.0 mg/ml | > 240 |
| Docetaxel | 10.0mg/ml | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml | > 240 |
| Ellence | 2.0 mg/ml | > 240 |
| Etoposide | 20.0 mg/ml | > 240 |
| Fludarabine | 25.0 mg/ml | > 240 |
| Fluorouracil | 50.0 mg/ml | > 240 |
| Gemcitabine | 38.0 mg/ml | > 240 |
| Idarubicin | 1.0 mg/ml | > 240 |
| Ifosfamide | 50.0 mg/ml | > 240 |
| Irinotecan | 20.0 mg/ml | > 240 |
| Mechlorethamine | 1.0 mg/ml | > 240 |
| Melphalan | 5.0 mg/ml | > 240 |
| Methotrexate | 25.0 mg/ml | > 240 |
| Mitomycin C | 0.5 mg/ml | > 240 |
| Mitoxantrone | 2.0 mg/ml | > 240 |
| Oxaliplatin | 5.0 mg/ml | > 240 |
| Paclitaxel | 6.0 mg/ml | > 240 |
| Rituximab | 10.0 mg/ml | > 240 |
| Thiotepa | 10.0 mg/ml | 39.0 |
| Topotecan | 1.0 mg/ml | > 240 |
| Trisenox | 1.0 mg/ml | > 240 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 |
| Vinorelbine | 10.0 mg/ml | > 240 |

FORM FDA 3881 (8/23)

Page 1 of 2

PSC Publishing Services [phone]

EF

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Please note that Carmustine and Thiotepa have extremely low permeation times of 11 minutes and 39 minutes respectively.

Warning: Do not use with Carmustine and Thiotepa

Fentanyl Permeation Resistance Claim- Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2ml) was found to have no breakthrough detected up to 240 minutes.

Type of Use (Select one or both, as applicable)

☐

Prescription Use (Part 21 CFR 801 Subpart D)

☑

Over-The-Counter Use (21 CFR 801 Subpart C)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23)

Page 2 of 2

PSC Publishing Services [phone]

EF

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120

Expiration Date: 07/31/2026

See PRA Statement below.

510(k) Number (if known)

K260312

Device Name

Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 standard practice for assessment of medical gloves to permeation by chemotherapy drugs:

Chemotherapy Drug Permeation

The following chemicals have been tested with these gloves.

| Chemotherapy Drugs | Concentration | Breakthrough Detection Time in Minutes |
| --- | --- | --- |
| Amethopterin | 25.0 mg/ml | > 240 |
| Bleomycin Sulfate | 15.0 mg/ml | > 240 |
| Busulfan | 6.0 mg/ml | > 240 |
| Carboplatin | 10.0 mg/ml | > 240 |
| Carmustine (BCNU) | 3.3 mg/ml | 10.0 |
| Cisplatin | 1.0 mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | > 240 |
| Cytarabine | 100.0mg/ml | > 240 |
| Dacarbazine (DTIC) | 10.0 mg/ml | > 240 |
| Docetaxel | 10.0mg/ml | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml | > 240 |
| Epirubicin | 2.0 mg/ml | > 240 |
| Etoposide | 20.0 mg/ml | > 240 |
| Fludarabine | 25.0 mg/ml | > 240 |
| Fluorouracil | 50.0 mg/ml | > 240 |
| Gemcitabine | 38.0 mg/ml | > 240 |
| Idarubicin | 1.0 mg/ml | > 240 |
| Ifosfamide | 50.0 mg/ml | > 240 |
| Irinotecan | 20.0 mg/ml | > 240 |
| Mechlorethamine | 1.0 mg/ml | > 240 |
| Melphalan | 5.0 mg/ml | > 240 |
| Methotrexate | 25.0 mg/ml | > 240 |
| Mitomycin C | 0.5 mg/ml | > 240 |
| Mitoxantrone | 2.0 mg/ml | > 240 |
| Oxaliplatin | 5.0 mg/ml | > 240 |
| Paclitaxel | 6.0 mg/ml | > 240 |
| Rituximab | 10.0 mg/ml | > 240 |
| Thiotepa | 10.0 mg/ml | 30.0 |
| Topotecan | 1.0 mg/ml | > 240 |
| Trisenox | 1.0 mg/ml | > 240 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 |
| Vinorelbine | 10.0 mg/ml | > 240 |

Please note that Carmustine and Thiotepa have extremely low permeation times of 10 minutes

FORM FDA 3881 (8/23)

Page 1 of 2

PSC Publishing Services [phone]

EF

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and 30 minutes respectively.

Warning: Do not use with Carmustine and Thiotepa

Gastric Acid Permeation Resistance Claim- Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.

Xylazine Permeation Resistance Claim- Under the testing conditions of ASTM D6978-05, Xylazine HCl Injection (100 mg/ml) was found to have no breakthrough detected up to 240 minutes.

Fentanyl Permeation Resistance Claim- Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2ml) was found to have no breakthrough detected up to 240 minutes.

Type of Use (Select one or both, as applicable)

☐

Prescription Use (Part 21 CFR 801 Subpart D)

☑

Over-The-Counter Use (21 CFR 801 Subpart C)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23)

Page 2 of 2

PSC Publishing Services [phone]

EF

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# GMP MEDICARE SDN. BHD.

## 510 (k) Summary

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.

### 1.0 Submitter

| 510(K) Owner’s Name | GMP Medicare Sdn. Bhd. |
| --- | --- |
| Address | LOT/PT 64593, Jalan Dahlia/KU8, Kawasan Perindustrian Meru Timur, 41050 Klang, Selangor D.E., Malaysia |
| Phone | [phone] |
| Email | [e-mail] |

### 2.0 Contact Person

| Contact Person | Ms. Ummi Salmah Othman |
| --- | --- |
| Designation | Assistant Manager, RA |
| Contact Number | [phone] |
| Contact Email | [e-mail] |
| Preparation Date | 3^{th} September 2026 |

### 3.0 Name of Device (1 of 2)

| Trade Name | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim |
| --- | --- |
| Common Name | Powder Free Nitrile Patient Examination Glove |
| Regulation No. | 21 CFR 880.6250 |
| Regulation Class | Class I |
| Product Code | LZA, LZC, QDO, OPJ |
| Product Classification Name | Polymer Patient Examination Glove |

### 4.0 Identification of the legally marketed device

#### Predicate Device

| Name of the device | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim |
| --- | --- |
| 510 (k) Number | K202003 |
| Company Name | GMP Medicare Sdn. Bhd. |

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## 5.0 Device Description

Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim meets all the requirements of ASTM D 6319-19(2023), ASTM D5151-19 (2023), ASTM D6124-06 (2022), ASTM D6978-05(2023), ISO 10993-10, ISO 10993-11, ISO 10993-23 and FDA 21 CFR 880.6250. The gloves are non-sterile, single use and disposable device. This product is available in sizes XS, S, M, L, and XL.

## 6.0 Intended Use of the Device

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

## 7.0 Indications for Use

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 standard practice for assessment of medical gloves to permeation by chemotherapy drugs:

Chemotherapy Drug Permeation

The following chemicals have been tested with these gloves.

| # | Concentration Drugs Detection time in Minutes | Concentration (mg/ml) | Breakthrough |
| --- | --- | --- | --- |
| 1. | Amethopterin | 25.0 | >240 |
| 2. | Bleomycin Sulfate | 15.0 | >240 |
| 3. | Busulfan | 6.0 | >240 |
| 4. | Carboplatin | 10.0 | >240 |
| 5. | Carmustine | 3.3 | 11.0 |
| 6. | Cisplatin | 1.0 | >240 |
| 7. | Cyclophosphamide | 20.0 | >240 |
| 8. | Cytarabine | 100.0 | >240 |
| 9. | Dacarbazine | 10.0 | >240 |
| 10. | Docetaxel | 10.0 | >240 |
| 11. | Doxorubicin Hydrochloride | 2.0 | >240 |
| 12. | Ellence | 2.0 | >240 |
| 13. | Etoposide | 20.0 | >240 |
| 14. | Fludarabine | 25.0 | >240 |
| 15. | Fluorouracil | 50.0 | >240 |
| 16. | Gemcitabine | 38.0 | >240 |
| 17. | Idarubicin | 1.0 | >240 |
| 18. | Ifosfamide | 50.0 | >240 |

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| # | Concentration Drugs Detection time in Minutes | Concentration (mg/ml) | Breakthrough |
| --- | --- | --- | --- |
| 19. | Irinotecan | 20.0 | >240 |
| 20. | Mechlorethamine | 1.0 | >240 |
| 21. | Melphalan | 5.0 | >240 |
| 22. | Methotrexate | 25.0 | >240 |
| 23. | Mitomycin C | 0.5 | >240 |
| 24. | Mitoxantrone | 2.0 | >240 |
| 25. | Oxaliplatin | 5.0 | >240 |
| 26. | Paclitaxel | 6.0 | >240 |
| 27. | Rituximab | 10.0 | >240 |
| 28. | Thiotepa | 10.0 | 39.0 |
| 29. | Topotecan | 1.0 | >240 |
| 30. | Trisenox | 1.0 | >240 |
| 31. | Vincristine Sulfate | 1.0 | >240 |
| 32. | Vinorelbine | 10.0 | >240 |
| 33. | Fentanyl Citrate | 100 mcg/2mL | >240 |

Please note that Carmustine and Thiotepa have extremely low permeation times of 11 minutes and 39 minutes respectively.

Warning: Do not use with Carmustine and Thiotepa

Fentanyl Permeation Resistance Claim- Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2ml) was found to have no breakthrough detected up to 240 minutes

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### 8.0 Device Modification

The proposed modification to the subject device is to add an expiration date (shelf -life) labelling claim for the Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim.

Refer below table for the details:

| Trade Name (Proprietary Name) | Modification Detail |
| --- | --- |
| Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim. | The change is limited solely to addition of an expiration date labelling claim and updated year 5 chemotherapy drug performance results. The proposed device remains identical to the predicate device with respect to materials, manufacturing process and packaging configuration. All other aspects including the Intended Use, Indication for Use and the technological characteristics remain unchanged. |

### 9.0 Summary of the Technological Characteristics of the Device:

Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim is summarized as compared to ASTM D6319-19 (2023) or equivalent standards. The Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim has the same technological characteristics as the predicate device (K202003), including technology of the design, materials, and product’s performance. The only modification is to include the expiry date logo in the product labelling. The technological characteristics remain unchanged and no new risk are introduced by the change.

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| Characteristic | Standards | Device Performance |
| --- | --- | --- |
| Dimension | ASTM D6319-19 (2023) | Meet |
| Physical Properties | ASTM D6319-19 (2023) | Meet |
| Freedom from pinholes | ASTM D6319-19 (2023) | Meet |
| | ASTM D6319-19 (2023) | Meet |
| Powder level | ASTM D6124-06 (2022) | Meet |
| | ASTM D6319-19 (2023) | Meet |
| Biocompatibility | Primary Skin Irritation (ISO 10993-10) | Passed Not a primary skin irritant under condition of the study |
| | Skin Sensitization (ISO 10993-10) | Passed Not a contact sensitizer under the conditions of the study |
| | Acute Systemic Toxicity (ISO 10993-11) | Passed Under the conditions of the study, there was no evidence of systemic toxicity |

**Table 1: Summary of Device Performance for ASTM Standard and Biocompatibility**

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# **10.0 Summary of Technological Characterization of New Device compared to Predicate Device for Substantial Equivalent**

| No. | Characteristics | **Predicate Device** Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove | **New Device** Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove | **Comparison between Predicate and New Device** |
| --- | --- | --- | --- | --- |
| | | **K202003** GMP Medicare Sdn. Bhd. | **K260312** GMP Medicare Sdn. Bhd | |
| 1. | Product code | LZA, LZC, QDO | LZA, LZC, QDO, OPJ | Same |
| 2. | 510(K) No. | K202003 | K260312 | Different |
| 3. | Intended use | A patient examination glove is disposable devices intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | A patient examination glove is disposable devices intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Same |
| 4. | Environment of Use | Healthcare professional facility | Healthcare professional facility | Same |
| 5. | Type of glove | Powder Free | Powder Free | Same |
| 6. | Material | Nitrile | Nitrile | Same |
| 7. | Color | Blue | Blue | Same |
| 8. | Technology of Glove Design | Ambidextrous | Ambidextrous | Same |
| 9. | Size | XS, S, M, L, XL | XS, S, M, L, XL | Same |
| 10. | Glove Length, mm | Min 240 | Min 240 | Same |
| 11. | Single Use | Yes | Yes | Same |
| 12. | Sterility | Non-Sterile | Non-Sterile | Same |
| 13. | Dimensions | ASTM D6319-19 | ASTM D6319-19 (2023) | Same |
| 14. | Freedom from holes | In Compliance with ASTM D6319-10 ASTM D5151-06 (2011) | In Compliance with ASTM D6319-19 (2023) ASTM D5151-19 (2023) | Same |
| 15. | Physical properties | Meet the requirement ASTM D6319-19 Before aging Tensile Strength: min 14MPa Elongation: min 500% After Aging Tensile Strength: min 14MPa Elongation: min 400% | Meet the requirement ASTM D6319-19 (2023) Before aging Tensile Strength: min 14MPa Elongation: min 500% After Aging Tensile Strength: min 14MPa Elongation: min 400% | Same |
| 16. | Powder residue | Meet the requirements ASTM D6319-19 ASTM D6124-06 (2011) Powder-free: ≤ 2mg per gloves | Meet the requirements ASTM D6319-19 (2023) ASTM D6124-06 (2022) Powder-free: ≤ 2mg per gloves | Same |

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| No. | Characteristics | **Predicate Device** Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove **K202003** GMP Medicare Sdn. Bhd. | **New Device** Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove **K260312** GMP Medicare Sdn. Bhd | **Comparison between Predicate and New Device** |
| --- | --- | --- | --- | --- |
| 17. | Biocompatibility test-Primary Skin Irritation ISO 10993-23 | Under the condition of the study. The device is not irritant. | Under the condition of the study. The device is not irritant. | Same |
| 18. | Biocompatibility test-Dermal Skin Sensitization ISO 10993-10 | Under the condition of the study. The device is not a sensitizer. | Under the condition of the study. The device is not a sensitizer. | Same |
| 19. | Acute Systemic Toxicity ISO 10993-11 | Under the conditions of the study, there was no evidence of systemic toxicity | Under the conditions of the study, there was no evidence of systemic toxicity | Same |
| 20. | Total Number of Chemotherapy Drugs | 32 Chemotherapy Drugs + Fentanyl | 32 Chemotherapy Drugs + Fentanyl | Same |
| 21. | Expiry Date Labelling Claim | Not Available | 5 years of shelf life | The subject and predicate devices are identical in all technological characteristics. The only modification is the addition of a 5-year expiration date labelling claim. Additionally, the Carmustine and Thiotepa chemotherapy performance result have been updated to reflect the year 5 permeation data. This update does not introduce any new warnings or precautionary statement. Realtime aging data support the proposed labelling, and the modification does not affect the safety effectiveness of the device. |

**Table 2: Summary of Technological Characterization of New Device compared to Predicate Device**

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| # | Chemotherapy drugs tested | Concentration (mg/ml) | Minimum Breakthrough Detection Time in Minutes | | Comparison |
| --- | --- | --- | --- | --- | --- |
| | | | Predicate | New Device | |
| | | | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove | |
| | | | K202003GMP Medicare Sdn. Bhd. | K260312GMP Medicare Sdn. Bhd. | |
| 1. | Amethopterin | 25.0 | >240 | >240 | Same |
| 2. | Bleomycin Sulfate | 15.0 | >240 | >240 | Same |
| 3. | Busulfan | 6.0 | >240 | >240 | Same |
| 4. | Carboplatin | 10.0 | >240 | >240 | Same |
| 5. | Carmustine | 3.3 | 11 | 11 | Same |
| 6. | Cisplatin | 1.0 | >240 | >240 | Same |
| 7. | Cyclophosphamide | 20.0 | >240 | >240 | Same |
| 8. | Cytarabine | 100.0 | >240 | >240 | Same |
| 9. | Dacarbazine | 10.0 | >240 | >240 | Same |
| 10. | Docetaxel | 10.0 | >240 | >240 | Same |
| 11. | Doxorubicin Hydrochloride | 2.0 | >240 | >240 | Same |
| 12. | Ellence | 2.0 | >240 | >240 | Same |
| 13. | Etoposide | 20.0 | >240 | >240 | Same |
| 14. | Fludarabine | 25.0 | >240 | >240 | Same |
| 15. | Fluorouracil | 50.0 | >240 | >240 | Same |
| 16. | Gemcitabine | 38.0 | >240 | >240 | Same |
| 17. | Idarubicin | 1.0 | >240 | >240 | Same |
| 18. | Ifosfamide | 50.0 | >240 | >240 | Same |
| 19. | Irinotecan | 20.0 | >240 | >240 | Same |
| 20. | Mechlorethamine | 1.0 | >240 | >240 | Same |
| 21. | Melphalan | 5.0 | >240 | >240 | Same |
| 22. | Methotrexate | 25.0 | >240 | >240 | Same |
| 23. | Mitomycin C | 0.5 | >240 | >240 | Same |
| 24. | Mitoxantrone | 2.0 | >240 | >240 | Same |
| 25. | Oxaliplatin | 5.0 | >240 | >240 | Same |
| 26. | Paclitaxel | 6.0 | >240 | >240 | Same |
| 27. | Rituximab | 10.0 | >240 | >240 | Same |
| 28. | Thiotepa | 10.0 | 39 | 39 | Same |
| 29. | Topotecan | 1.0 | >240 | >240 | Same |
| 30. | Trisenox | 1.0 | >240 | >240 | Same |
| 31. | Vincristine Sulfate | 1.0 | >240 | >240 | Same |
| 32. | Vinorelbine | 10.0 | >240 | >240 | Same |
| 33. | Fentanyl Citrate | 100.0 mcg/2mL | >240 | >240 | Same |

Table 3: Summary of Chemotherapy Drugs Tested between Predicate and New Device

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## 11.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:

The current device, Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim meets standard requirements of ASTM D 6319-19(2023), ASTM D5151-19 (2023), ASTM D6124-06 (2022), D6978-05 (2023) and ISO 10993-10. Biocompatibility test indicated that the device is non-irritant and non-sensitized under the condition of the study. The performance test data of non-clinical tests that support the determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements).

The new device and the predicate share the same intended use, same material, same specifications for thickness and length, similar labelling according to the glove guidance, and same compliance with standards for physical properties, powder free, biocompatibility and water tightness. Thus, the device is substantial equivalent to the predicate device.

The only modification is an update on shelf life to include the expiry date logo in the product labelling. The expiration date labelling claim is supported by 5- year real-time shelf-life testing. Real-time stability testing was conducted in accordance with applicable ASTM standards, including ASTM D7160, ASTM D6319, ASTM D5151, and demonstrated continued compliance with physical property and barrier integrity requirements through the labelled shelf life.

| Testing | Purpose | Criteria | Result |
| --- | --- | --- | --- |
| Real-Time 5-Year Shelf Life Testing (ASTM D7160) Physical Properties & Barrier Integrity ASTM D6319 & ASTM D5151 | To demonstrate that long term aging does not impact physical properties or barrier integrity. | i. Conform to ASTM D6319 tensile strength of at least minimum 14 MPa and ultimate elongation of at least minimum 500% ii. Freedom from holes per ASTM D5151 (AQL ≤2.5) | Pass |
| Chemotherapy Drug Permeation and Fentanyl Citrate (ASTM D6978) **Chemotherapy Drug and Fentanyl Citrate permeation testing in accordance with ASTM D6978 was performed on glove aged through the full 5-year real-time shelf life.* | To confirm that 5-year real time aging does not adversely affect chemotherapy drug and Fentanyl Citrate resistance. | Continued support of previously cleared chemotherapy drugs and Fentanyl Citrate resistance labeling and/or warning/precautionary statements | **Carmustine Minimum breakthrough time:** i. Unaged Glove: 11.0 minutes ii. Aged Glove: 30.0 minutes **Thiotepa Minimum breakthrough time:** i. Unaged Glove: 39.0 minutes ii. Aged Glove: 40.0 minutes |

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| Test | Purpose | Criteria | Result |
| --- | --- | --- | --- |
| Standard Test Method for Detection of Holes in Medical Gloves ASTM D6319-19(2023) | To demonstrate glove integrity | Freedom from holes AQL 2.5 | Pass |
| Standard Test Method for Residual Powder on Medical Gloves ASTM D6124-06(2022) | To demonstrate the gloves are 'powder free' | Average less than 2 mg/glove | Pass |
| Dimensional Conformance ASTM D6319-19 (2023) | To demonstrate appropriate dimensions for labeled sizes | Conforms to ASTM D6319 width, thickness, and length requirements for XS, S, M, L, and XL AQL 4.0 | Pass |
| Tensile Performance ASTM D6319-19 (2023) | To demonstrate adequate tensile properties | Conforms to ASTM D6319 tensile strength of at least 14MPa and ultimate elongation of at least 500% requirements prior to aging, and tensile strength of at least 14MPa and ultimate strength of at least 400% after accelerated aging AQL 4.0 | Pass |
| Biocompatibility: Skin Irritation ISO 10993-23 | To demonstrate low potential for skin irritation | Under the conditions of the study, not an irritant. | Pass |
| Biocompatibility: Skin Sensitization ISO 10993-10 | To demonstrate low potential for skin sensitization | Under the conditions of the study, not a sensitizer | Pass |
| Biocompatibility: Acute Oral Toxicity Study ISO 10993-11 | To demonstrate low potential for acute systemic toxicity | Under the conditions of the study, the device does not induce acute systemic toxicity response. | Pass |

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| Test | Purpose | Criteria | Result |
| --- | --- | --- | --- |
| ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs | To demonstrate barrier properties of gloves to permeation of chemotherapy drugs and fentanyl citrate: Amethopterin (25 mg/ml) Bleomycin Sulfate (15 mg/ml) Busulfan (6 mg/ml) Carboplatin (10 mg/ml) Carmustine (3.3 mg/ml) Cisplatin (1 mg/ml) Cyclophosphamide (20 mg/ml) Cytarabine (100 mg/ml) Dacarbazine (10 mg/ml) Docetaxel (10 mg/ml) Doxorubicin Hydrochloride (2 mg/ml) Ellence (2 mg/ml) Etoposide (20 mg/ml) Fludarabine (25 mg/ml) Fluorouracil (50 mg/ml) Gemcitabine (38 mg/ml) Idarubicin (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan (20 mg/ml) Mechlorethamine (1 mg/ml) Melphalan (5 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone (2 mg/ml) Oxaliplatin (5 mg/ml) Paclitaxel (6 mg/ml) Rituximab (10 mg/ml) Thiotepa (10 mg/ml) Topotecan (1 mg/ml) Trisenox (1 mg/ml) Vincristine Sulfate (1 mg/ml) Vinorelbine (10 mg/ml) Fentanyl Citrate (100 mcg/2ml) | Not Available | **Carmustine Minimum breakthrough time:** i.Unaged Glove: 11.0 minutes **Thiotepa Minimum breakthrough time:** i.Unaged Glove: 39.0minutes No breakthrough detected during 240- minute test duration for remaining tested chemotherapy drugs and fentanyl citrate for Unaged Glove and Aged Glove. |

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# **12.0 Summary of Comparison of the safety and effectiveness of proposed device compared to the predicate**

| No. | Characteristics | **Predicate Device** Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove | **New Device** Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove | **Comparison between Predicate and New Device Safety /effectiveness assessment** |
| --- | --- | --- | --- | --- |
| | | **K202003** GMP Medicare Sdn. Bhd. | **K260312** GMP Medicare Sdn. Bhd | |
| 1. | Product code | LZA, LZC, QDO | LZA, LZC, QDO, OPJ | Same |
| 2. | 510(K) No. | K202003 | K260312 | Different |
| 3. | Intended use | A patient examination glove is disposable devices intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | A patient examination glove is disposable devices intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Same |
| 4. | Environment of Use | Healthcare professional facility | Healthcare professional facility | Same |
| 5. | Type of glove | Powder Free | Powder Free | Same |
| 6. | Material | Nitrile | Nitrile | Same |
| 7. | Color | Blue | Blue | Same |
| 8. | Technology of Glove Design | Ambidextrous | Ambidextrous | Same |
| 9. | Size | XS, S, M, L, XL | XS, S, M, L, XL | Same |
| 10. | Glove Length, mm | Min 240 | Min 240 | Same |
| 11. | Single Use | Yes | Yes | Same |
| 12. | Sterility | Non-Sterile | Non-Sterile | Same |
| 13. | Dimensions | ASTM D6319-19 | ASTM D6319-19 (2023) | Same |
| 14. | Freedom from holes | In Compliance with ASTM D6319-10 ASTM D5151-06 (2011) | In Compliance with ASTM D6319-19 (2023) ASTM D5151-19 (2023) | Same |
| 15. | Physical properties | Meet the requirement ASTM D6319-19 Before aging Tensile Strength: min 14MPa Elongation: min 500% After Aging Tensile Strength: min 14MPa Elongation: min 400% | Meet the requirement ASTM D6319-19 (2023) Before aging Tensile Strength: min 14MPa Elongation: min 500% After Aging Tensile Strength: min 14MPa Elongation: min 400% | Same |

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| No. | Characteristics | **Predicate Device** Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove **K202003** GMP Medicare Sdn. Bhd. | **New Device** Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove **K260312** GMP Medicare Sdn. Bhd | **Comparison between Predicate and New Device Safety /effectiveness assessment** |
| --- | --- | --- | --- | --- |
| 16. | Powder residue | Meet the requirements ASTM D6319-19 ASTM D6124-06 (2011) Powder-free: ≤ 2mg per gloves | Meet the requirements ASTM D6319-19 (2023) ASTM D6124-06 (2022) Powder-free: ≤ 2mg per gloves | Same |
| 17. | Biocompatibility test-Primary Skin Irritation ISO 10993-23 | Under the condition of the study. The device is not irritant. | Under the condition of the study. The device is not irritant. | Same |
| 18. | Biocompatibility test-Dermal Skin Sensitization ISO 10993-10 | Under the condition of the study. The device is not a sensitizer. | Under the condition of the study. The device is not a sensitizer. | Same |
| 19. | Acute Systemic Toxicity ISO 10993-11 | Under the conditions of the study, there was no evidence of systemic toxicity | Under the conditions of the study, there was no evidence of systemic toxicity | Same |
| 20. | Total Number of Chemotherapy Drugs | 32 Chemotherapy Drugs + Fentanyl | 32 Chemotherapy Drugs + Fentanyl | Same |

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| No. | Characteristics | Predicate Device Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove **K202003** GMP Medicare Sdn. Bhd. | New Device Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove **K260312** GMP Medicare Sdn. Bhd | Comparison between Predicate and New Device Safety /effectiveness assessment |
| --- | --- | --- | --- | --- |
| 21. | Expiry Date Labelling Claim | Not Available | 5 years of shelf life | The subject and predicate devices are identical in all technological characteristics. The only modification is the addition of a 5-year expiration date labelling claim. Additionally, the Carmustine and Thiotepa chemotherapy performance result have been updated to reflect the year 5 permeation data. This update does not introduce any new warnings or precautionary statement. Realtime aging data support the proposed labelling, and the modification does not affect the safety effectiveness of the device. |

Overall conclusion

The proposed device is as safe and effective as the predicate device.

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### **13.0 Clinical testing**

No clinical study is included in this submission.

### **14.0 Conclusion**

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

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# GMP MEDICARE SDN. BHD.

## 510 (k) Summary

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.

### 1.0 Submitter

| 510(K) Owner’s Name | GMP Medicare Sdn. Bhd. |
| --- | --- |
| Address | LOT/PT 64593, Jalan Dahlia/KU8, Kawasan Perindustrian Meru Timur, 41050 Klang, Selangor D.E., Malaysia |
| Phone | [phone] |
| Email | [e-mail] |

### 2.0 Contact Person

| Contact Person | Ms. Ummi Salmah Othman |
| --- | --- |
| Designation | Assistant Manager, RA |
| Contact Number | [phone] |
| Contact Email | [e-mail] |
| Preparation Date | 3^{rd} September 2026 |

### 3.0 Name of Device (2 of 2)

| Trade Name | Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid |
| --- | --- |
| Common Name | Powder Free Nitrile Patient Examination Glove |
| Regulation No. | 21 CFR 880.6250 |
| Regulation Class | Class I |
| Product Code | LZA, LZC, QDO, OPJ |
| Product Classification Name | Polymer Patient Examination Glove |

### 4.0 Identification of the legally marketed device

#### Predicate Device

| Name of the device | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove |
| --- | --- |
| 510 (k) Number | K202003 |
| Company Name | GMP Medicare Sdn. Bhd. |

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## 5.0 Device Description

Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid meets all the requirements of ASTM D 6319-19(2023), ASTM D5151-19 (2023), ASTM D6124-06 (2022), ASTM D6978-05 (2023), ISO 10993-23, ISO 10993-10, ISO 10993-11 and FDA 21 CFR 880.6250.

The gloves are non-sterile, single use and disposable device.

This product is available in sizes XS, S, M, L, XL

## 6.0 Device Modification

The proposed modification to the subject device is adding new colour which is Violet Blue and addition of 32 chemotherapy drugs, Xylazine, Fentanyl and Gastric Acid Permeation Resistance claim for the Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim.

Refer below table for detail:

| Trade Name (Proprietary Name) | Modification Detail |
| --- | --- |
| Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid | The modification is changing glove formulation by replacing blue colorant with new colour which is Violet Blue and addition of 32 chemotherapy drugs, Xylazine, Fentanyl and Gastric Acid Permeation Resistance claim. |

## 7.0 Intended Use of the Device

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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## 8.0 Indications for Use

Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 standard practice for assessment of medical gloves to permeation by chemotherapy drugs:

Chemotherapy Drug Permeation

The following chemicals have been tested with these gloves.

| # | Concentration Drugs Detection | Concentration (mg/ml) | Breakthrough time in Minutes |
| --- | --- | --- | --- |
| 1. | Amethopterin | 25.0 | >240 |
| 2. | Bleomycin Sulfate | 15.0 | >240 |
| 3. | Busulfan | 6.0 | >240 |
| 4. | Carboplatin | 10.0 | >240 |
| 5. | Carmustine | 3.3 | 10.0 |
| 6. | Cisplatin | 1.0 | >240 |
| 7. | Cyclophosphamide | 20.0 | >240 |
| 8. | Cytarabine | 100.0 | >240 |
| 9 | Dacarbazine | 10.0 | >240 |
| 10. | Docetaxel | 10.0 | >240 |
| 11. | Doxorubicin Hydrochloride | 2.0 | >240 |
| 12. | Epirubicin HCL | 2.0 | >240 |
| 13. | Etoposide | 20.0 | >240 |
| 14. | Fludarabine | 25.0 | >240 |
| 15. | Fluorouracil | 50.0 | >240 |
| 16. | Gemcitabine | 38.0 | >240 |
| 17. | Idarubicin | 1.0 | >240 |
| 18. | Ifosfamide | 50.0 | >240 |
| 19. | Irinotecan | 20.0 | >240 |
| 20. | Mechlorethamine | 1.0 | >240 |
| 21. | Melphalan | 5.0 | >240 |
| 22. | Methotrexate | 25.0 | >240 |
| 23. | Mitomycin C | 0.5 | >240 |
| 24. | Mitoxantrone | 2.0 | >240 |
| 25. | Oxaliplatin | 5.0 | >240 |
| 26. | Paclitaxel | 6.0 | >240 |
| 27. | Rituximab | 10.0 | >240 |
| 28. | Thiotepa | 10.0 | 30.0 |
| 29. | Topotecan | 1.0 | >240 |
| 30. | Trisenox | 1.0 | >240 |
| 31. | Vincristine Sulfate | 1.0 | >240 |
| 32. | Vinorelbine | 10.0 | >240 |
| 33. | Fentanyl Citrate | 100 mcg/2mL | >240 |
| 34. | Xylazine | 100 | >240 |
| 35. | Simulated Gastric Acid | N/A | >240 |

Please note that Carmustine and Thiotepa have extremely low permeation times of 10 minutes and 30 minutes respectively.

Warning: Do not use with Carmustine and Thiotepa

Gastric Acid Permeation Resistance Claim- Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.

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Xylazine Permeation Resistance Claim- Under the testing conditions of ASTM D6978-05, Xylazine HCl Injection (100 mg/ml) was found to have no breakthrough detected up to 240 minutes. Fentanyl Permeation Resistance Claim- Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2ml) was found to have no breakthrough detected up to 240 minutes.

## 9.0 Summary of the Technological Characteristics of the Device:

The new device and the predicate share the same intended use and same specifications for thickness and length, similar labelling according to the glove guidance, and same compliance with standards for physical properties, powder free, biocompatibility and water tightness.

The only modifications are the addition of a new color, which is Violet Blue, and the addition of Xylazine and Gastric Acid Permeation Resistance claims, with Dioxazine Violet (CAS 6358-30-1) added as a colorant, and different permeation test results for Carmustine and Thiotepa. Therefore, the Violet Blue gloves have some differences in materials and technological characteristics compared to the predicate. The Violet Blue glove is different from the predicate, but testing demonstrates that it is as safe and effective as the predicate, with no new or different risks introduced by these changes.

| Characteristic | Standards | Device Performance |
| --- | --- | --- |
| Dimension | ASTM D6319-19 (2023) | Meet |
| Physical Properties | ASTM D6319-19 (2023) | Meet |
| Freedom from pinholes | ASTM D6319-19 (2023) | Meet |
| | ASTM D6319-19 (2023) | Meet |
| Powder level | ASTM D6124-06 (2022) | Meet |
| | ASTM D6319-19 (2023) | Meet |
| Biocompatibility | Primary Skin Irritation (ISO 10993-10) | Passed Not a primary skin irritant under condition of the study |
| | Skin Sensitization (ISO 10993-10) | Passed Not a contact sensitizer under the conditions of the study |
| | Acute Systemic Toxicity (ISO 10993-11) | Passed Under the conditions of the study, there was no evidence of systemic toxicity |

Table 1: Summary of Device Performance for ASTM Standard and Biocompatibility

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# **10.0 Summary of Technological Characterization of New Device compared to Predicate Device for Substantial Equivalent**

| No. | Characteristics | **Predicate Device** Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove GMP Medicare Sdn. Bhd. **K202003** | **New Device** Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid GMP Medicare Sdn.bhd. **K260312** | **Comparison between Predicate and New Device** |
| --- | --- | --- | --- | --- |
| 1. | Product code | LZA, LZC, QDO | LZA, LZC, QDO, OPJ | Same |
| 2. | 510(K) No. | K202003 | K260312 | Different |
| 3. | Intended use | A patient examination glove is disposable devices intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. | A patient examination glove is disposable devices intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. | Same |
| 4. | Environment of Use | Healthcare professional facility | Healthcare professional facility | Same |
| 5. | Type of glove | Powder Free | Powder Free | Same |
| 6. | Material | Nitrile | Nitrile | Same |
| 7. | Color | Blue | Violet Blue | Different |
| 8. | Technology of Glove Design | Ambidextrous | Ambidextrous | Same |
| 9. | Size | XS, S, M, L, XL | XS, S, M, L, XL | Same |

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| No. | Characteristics | **Predicate Device** Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove GMP Medicare Sdn. Bhd. **K202003** | **New Device** Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid GMP Medicare Sdn. Bhd. **K260312** | **Comparison between Predicate and New Device** |
| --- | --- | --- | --- | --- |
| 10. | Glove Length, mm | Min 240 | Min 240 | Same |
| 11. | Single Use | Yes | Yes | Same |
| 12. | Sterility | Non Sterile | Non Sterile | Same |
| 13. | Dimensions | ASTM D6319-19 | ASTM D6319-19 (2023) | Same |
| 14. | Freedom from holes | In Compliance with ASTM D6319-10 ASTM D5151-06 (2011) | In Compliance with ASTM D6319-19 (2023) ASTM D5151-19 (2023) | Same |
| 15. | Physical properties | Meet the requirement ASTM D6319-19 Before aging Tensile Strength: min 14MPa Elongation : min 500% After Aging Tensile Strength: min 14MPa Elongation : min 400% | Meet the requirement ASTM D6319-19 (2023) Before aging Tensile Strength: min 14MPa Elongation : min 500% After Aging Tensile Strength: min 14MPa Elongation : min 400% | Same |
| 16. | Powder residue | Meet the requirements ASTM D6319-19 ASTM D6124-06 (2011) Powder-free : ≤ 2mg per gloves | Meet the requirements ASTM D6319-19 (2023) ASTM D6124-06 (2022) Powder-free : ≤ 2mg per gloves | Same |

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| No. | Characteristics | **Predicate Device** | **New Device** | **Comparison between Predicate and New Device** |
| --- | --- | --- | --- | --- |
| | | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove GMP Medicare Sdn. Bhd. **K202003** | Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid GMP Medicare Sdn. Bhd. **K260312** | |
| 17. | Biocompatibility test- Primary skin irritation | Under the condition of the study. The device is not irritant. | Under the condition of the study. The device is not irritant. | Same |
| 18. | Biocompatibility test- Skin sensitization | Under the condition of the study. The device is not a sensitizer. | Under the condition of the study. The device is not a sensitizer. | Same |
| 19. | Biocompatibility test - Acute Systemic Toxicity ISO 10993-11 | Under the conditions of the study, there was no evidence of systemic toxicity | Under the conditions of the study, there was no evidence of systemic toxicity | Same |
| 20. | Total Number of Chemotherapy Drugs | 32 Chemotherapy Drugs + Fentanyl | 32 Chemotherapy Drugs + Fentanyl +Xylazine + Gastric Acid | Different |

**Table 2: Summary of Technological Characterization of New Device compared to Predicate Device**

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| # | Chemotherapy drugs tested | Concentration (mg/ml) | Breakthrough Detection Time in Minutes | | Comparison |
| --- | --- | --- | --- | --- | --- |
| | | | Predicate | New Device | |
| | | | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove | Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid | |
| | | | GMP Medicare Sdn Bhd. **K202003** | GMP Medicare Sdn. Bhd. **K260312** | |
| 1. | Amethopterin | 25.0 | >240 | >240 | Same |
| 2. | Bleomycin Sulfate | 15.0 | >240 | >240 | Same |
| 3. | Busulfan | 6.0 | >240 | >240 | Same |
| 4. | Carboplatin | 10.0 | >240 | >240 | Same |
| 5. | Carmustine | 3.3 | 11 | 10 | Different |
| 6. | Cisplatin | 1.0 | >240 | >240 | Same |
| 7. | Cyclophosphamide | 20.0 | >240 | >240 | Same |
| 8. | Cytarabine | 100.0 | >240 | >240 | Same |
| 9. | Dacarbazine | 10.0 | >240 | >240 | Same |
| 10. | Docetaxel | 10.0 | >240 | >240 | Same |
| 11. | Doxorubicin Hydrochloride | 2.0 | >240 | >240 | Same |
| 12. | Epirubicin HCL | 2.0 | >240 | >240 | Same |
| 13. | Etoposide | 20.0 | >240 | >240 | Same |
| 14. | Fludarabine | 25.0 | >240 | >240 | Same |
| 15. | Fluorouracil | 50.0 | >240 | >240 | Same |
| 16. | Gemcitabine | 38.0 | >240 | >240 | Same |
| 17. | Idarubicin | 1.0 | >240 | >240 | Same |

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| # | Chemotherapy drugs tested | Concentration (mg/ml) | Breakthrough Detection Time in Minutes | | Comparison |
| --- | --- | --- | --- | --- | --- |
| | | | Predicate | New Device | |
| | | | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove | Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid | |
| | | | GMP Medicare Sdn. Bhd. **K202003** | GMP Medicare Sdn. Bhd. **K260312** | |
| 18. | Ifosfamide | 50.0 | >240 | >240 | Same |
| 19. | Irinotecan | 20.0 | >240 | >240 | Same |
| 20. | Mechlorethamine | 1.0 | >240 | >240 | Same |
| 21. | Melphalan | 5.0 | >240 | >240 | Same |
| 22. | Methotrexate | 25.0 | >240 | >240 | Same |
| 23. | Mitomycin C | 0.5 | >240 | >240 | Same |
| 24. | Mitoxantrone | 2.0 | >240 | >240 | Same |
| 25. | Oxaliplatin | 5.0 | >240 | >240 | Same |
| 26. | Paclitaxel | 6.0 | >240 | >240 | Same |
| 27. | Rituximab | 10.0 | >240 | >240 | Same |
| 28. | Thiotepa | 10.0 | 39 | 30 | Different |
| 29. | Topotecan | 1.0 | >240 | >240 | Same |
| 30. | Trisenox | 1.0 | >240 | >240 | Same |
| 31. | Vincristine Sulfate | 1.0 | >240 | >240 | Same |
| 32. | Vinorelbine | 10.0 | >240 | >240 | Same |
| 33. | Fentanyl Citrate | 100 mcg/2mL | >240 | >240 | Same |
| 34. | Xylazine | 100 | Not Tested | >240 | Different |
| 35. | Simulated Gastric Acid | N/A | Not Tested | >240 | Different |

Table 3: Summary of Chemotherapy Drugs Tested between Predicate and New Device

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## 11.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data

The current device, Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid meets standard requirements of ASTM D 6319-19(2023), ASTM D5151-19 (2023), ASTM D6124-06 (2022), D6978-05 (2023), ISO 10993-10, ISO 10993-11, and ISO 10993-23. Biocompatibility test indicated that the device is non-irritant and non-sensitized under the condition of the study. The performance test data of non-clinical tests that support the determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements).

The new device and the predicate share the same intended use, same material, same specifications for thickness and length, similar labelling according to the glove guidance, and same compliance with standards for physical properties, powder free, biocompatibility and water tightness. Thus, the device is substantial equivalent to the predicate. The only modification is adding new color which is Violet Blue and addition of 32 chemotherapy drugs, Xylazine, Fentanyl and Gastric Acid Permeation Resistance claim. The technological characteristics remain unchanged and no new risk are introduced by the change.

| Testing | Purpose | Criteria | Result |
| --- | --- | --- | --- |
| Biocompatibility Testing | To demonstrate low potential for skin irritation, skin sensitization and acute systemic toxicity | Under the conditions of the study, not an irritant Under the conditions of the study, not a sensitizer Under the conditions of the study, the device does not induce acute systemic toxicity response | Pass. |

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# **12.0 Summary of Comparison of the safety and effectiveness of to the predicate**

| No. | Characteristics | **Predicate Device** Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove GMP Medicare Sdn. Bhd. **K202003** | **New Device** Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid GMP Medicare Sdn.bhd. **K260312** | **Comparison between Predicate and New Device Safety /effectiveness assessment** |
| --- | --- | --- | --- | --- |
| 1. | Product code | LZA, LZC, QDO | LZA, LZC, QDO, OPJ | Same |
| 2. | 510(K) No. | K202003 | K260312 | Different |
| 3. | Intended use | A patient examination glove is disposable devices intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | A patient examination glove is disposable devices intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Same |
| 4. | Environment of Use | Healthcare professional facility | Healthcare professional facility | Same |
| 5. | Type of glove | Powder Free | Powder Free | Same |
| 6. | Material | Nitrile | Nitrile | Same |
| 7. | Color | Blue | Violet Blue | Different |
| 8. | Technology of Glove Design | Ambidextrous | Ambidextrous | Same |
| 9. | Size | XS, S, M, L, XL | XS, S, M, L, XL | Same |

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| No. | Characteristics | **Predicate Device** Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove GMP Medicare Sdn. Bhd. **K202003** | **New Device** Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid GMP Medicare Sdn. Bhd. **K260312** | **Comparison between Predicate and New Device Safety /effectiveness assessment** |
| --- | --- | --- | --- | --- |
| 10. | Glove Length, mm | Min 240 | Min 240 | Same |
| 11. | Single Use | Yes | Yes | Same = |
| 12. | Sterility | Non Sterile | Non Sterile | Same |
| 13. | Dimensions | ASTM D6319-19 | ASTM D6319-19 (2023) | Same |
| 14. | Freedom from holes | In Compliance with ASTM D6319-10 ASTM D5151-06 (2011) | In Compliance with ASTM D6319-19 (2023) ASTM D5151-19 (2023) | Same |
| 15. | Physical properties | Meet the requirement ASTM D6319-19 Before aging Tensile Strength: min 14MPa Elongation : min 500% After Aging Tensile Strength: min 14MPa Elongation : min 400% | Meet the requirement ASTM D6319-19 (2023) Before aging Tensile Strength: min 14MPa Elongation : min 500% After Aging Tensile Strength: min 14MPa Elongation : min 400% | Same |
| 16. | Powder residue | Meet the requirements ASTM D6319-19 ASTM D6124-06 (2011) Powder-free : ≤ 2mg per gloves | Meet the requirements ASTM D6319-19 (2023) ASTM D6124-06 (2022) Powder-free : ≤ 2mg per gloves | Same |

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| No. | Characteristics | Predicate Device | New Device | Comparison between Predicate and New Device Safety /effectiveness assessment |
| --- | --- | --- | --- | --- |
| | | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim Glove GMP Medicare Sdn. Bhd. **K202003** | Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid GMP Medicare Sdn. Bhd. **K260312** | |
| 17. | Biocompatibility test- Primary skin irritation | Under the condition of the study. The device is not irritant. | Under the condition of the study. The device is not irritant. | Same |
| 18. | Biocompatibility test- Skin sensitization | Under the condition of the study. The device is not a sensitizer. | Under the condition of the study. The device is not a sensitizer. | Same |
| 19. | Biocompatibility test - Acute Systemic Toxicity ISO 10993-11 | Under the conditions of the study, there was no evidence of systemic toxicity | Under the conditions of the study, there was no evidence of systemic toxicity | Same |
| 20. | Total Number of Chemotherapy Drugs | 32 Chemotherapy Drugs + Fentanyl | 32 Chemotherapy Drugs + Fentanyl +Xylazine + Gastric Acid | Different |

Overall conclusion

The proposed device is as safe and effective as the predicate device.

### 13.0 Clinical Testing

No clinical study is included in this submission.

### 14.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

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