Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid

K233560 · Eco Medi Glove Sdn. Bhd. · LZA · Feb 26, 2024 · General Hospital

Device Facts

• Record ID: K233560
• Device Name: Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid
• Applicant: Eco Medi Glove Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Feb 26, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid is a disposable device intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use. In addition, these gloves were tested for use with Chemotherapy drugs, Fentanyl, and Gastric Acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

Device Story

Disposable, non-sterile, blue nitrile examination glove; worn on examiner's hand/finger to prevent cross-contamination. Device provides barrier protection; tested for permeation resistance against chemotherapy drugs, fentanyl, and gastric acid per ASTM D6978-05. Used in clinical settings; intended for over-the-counter use. Healthcare providers use the glove as a physical barrier; output is the glove itself. Benefits include protection against patient-to-examiner contamination and specific chemical exposure during handling of hazardous drugs.

Clinical Evidence

Clinical study conducted using Modified Draize-95 Test to evaluate potential for Type IV allergy. Study included 205 subjects (ages 18-60, 58% female, 42% male) representing diverse ethnic backgrounds (Caucasian, Afro-Caribbean, Asiatic). Results showed no clinical evidence of residual chemical additives at levels inducing Type IV allergy in the un-sensitized general population.

Technological Characteristics

Material: Nitrile latex compound. Form factor: Ambidextrous, finger-textured, rolled beading cuff. Sizes: XXS, XS, S, M, L, XL, XXL. Standards: ASTM D6319-19 (physical properties/dimensions), ASTM D5151-19 (pinholes), ASTM D6124-06 (residual powder), ASTM D6978-05 (chemotherapy permeation). Biocompatibility: ISO 10993-10, 10993-11, 10993-23. Non-sterile. No software or energy source.

Indications for Use

Indicated for use as a disposable, non-sterile, over-the-counter patient examination glove worn on the hand or finger to prevent cross-contamination between patient and examiner. Suitable for use with chemotherapy drugs, fentanyl, and gastric acid.

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

• Powder Free Examination Glove (Blue) with Low Dermatitis Claim and with tested for use with Chemotherapy Drugs Claims (K181066)

Reference Devices

• Halyard Lavender, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K202622)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

February 26, 2024

Eco Medi Glove Sdn. Bhd. Suresh Kumar Sivalingam QA Manager Lot 23826, Jalan Tembaga Kuning Kamunting Raya Industrial Estate Taiping, Perak Darul Ridzuan 34600 Malaysia

Re: K233560

Trade/Device Name: Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, QDO, OPJ Dated: November 28, 2023 Received: November 28, 2023

Dear Suresh Kumar Sivalingam:

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/cdrb/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.

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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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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.

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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,

Image /page/1/Picture/7 description: The image shows the text "Allan Guan-S" in a large, sans-serif font. The text is black and is set against a white background. There is a faint, light blue watermark in the background that is partially obscured by the text.

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

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DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery 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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# Indications for Use

detection time in Minutes

510(k) Number (if known) K233560

## Device Name

Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid

## Indications for Use (Describe)

Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid is a disposable device intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use.

In addition, these gloves were tested for use with Chemotherapy drugs, Fentanyl, and Gastric Acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

| Chemotherapy Drug and Fentanyl Concentration | Minimum Breakthrough |
|-------------------------------------------------|----------------------|
| 1. Bendamustine HCl 5mg/ml (5,000ppm) | >240 minutes |
| 2. Bleomycin Sulfate 15mg/ml (15,000ppm) | >240 minutes |
| 3. Busulfan 6mg/ml (6,000 ppm) | >240 minutes |
| 4. Carboplatin 10mg/ml (10,000 ppm) | >240 minutes |
| 5. Carfilzomib 2mg/ml (2,000ppm) | >240 minutes |
| 6. Carmustine 3.3mg/ml (3,300 ppm) | 22.0 minutes |
| 7. Cetuximab 2mg/ml (2,000 ppm) | >240 minutes |
| 8. Cisplatin 1mg/ml (1,000ppm) | >240 minutes |
| 9. Cladribine 1mg/ml (1,000ppm) | >240 minutes |
| 10. Cyclophosphamide, 20 mg/ml (20,000ppm) | >240 minutes |
| 11. Cytarabine (Cytosine), (100,000ppm) | >240 minutes |
| 12. Dacarbazine, 10mg/ml (10,000ppm) | >240 minutes |
| 13. Daunorubicin, HCl, 5mg/ml (5,000 ppm) | >240 minutes |
| 14. Decitabine, 5mg/ml (5,000 ppm) | >240 minutes |
| 15. Docetaxel 10mg/ml (10,000ppm) | >240 minutes |
| 16. Doxorubicin HCl, 2mg/ml (2,000 ppm) | >240 minutes |
| 17. Epirubicin HCl, 2mg/ml (2,000 ppm) | >240 minutes |
| 18. Etoposide, 20mg/ml (20,000 ppm) | >240 minutes |
| 19. Fludarabine Phosphate, 25mg/ml (25,000 ppm) | >240 minutes |
| 20. Fluorouracil, 50 mg/ml (50,000 ppm) | >240 minutes |
| 21. Gemcitabine, HCl, 38mg/ml (38,000 ppm) | >240 minutes |
| 22. Idarubicin HCl, 1mg/ml (1,000ppm) | >240 minutes |
| 23. Ifosfamide, 50mg/ml (50,000 ppm) | >240 minutes |
| 24. Irinotecan, HCl, 20mg/ml (20,000ppm) | >240 minutes |
| 25. Mechlorethamine HCl, 1 mg/ml (1,000 ppm) | >240 minutes |
| 26. Melphalan HCl, 5mg/ml (5,000 ppm) | >240 minutes |
| 27. Methotrexate, 25mg/ml (25,000 ppm) | >240 minutes |
| 28. Mitomycin C, 0.5mg/ml (500 ppm) | >240 minutes |
| 29. Mitoxantrone HCl, 2mg/ml (2,000 ppm) | >240 minutes |
| 30. Oxaliplatin, 5mg/ml (5,000ppm) | >240 minutes |
| 31. Paclitaxel, 6mg/ml (6,000ppm) | >240 minutes |
| 32. Paraplatin, 10mg/ml (10,000 ppm) | >240 minutes |
| 33. Pemetrexed, 25mg/ml (25,000 ppm) | >240 minutes |

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| 34. Raltitrexed, 0.5mg/ml (500 ppm) | >240 minutes |
|-----------------------------------------------------------------------------------------------------|--------------|
| 35. Thiotepa, 10mg/ml (10,000 ppm) | 34.2 minutes |
| 36. Topotecan, 1mg/ml (1,000 ppm) | >240 minutes |
| 37. Trisenox (Arsenic Trioxide), 1mg/ml (1,000ppm) | >240 minutes |
| 38. Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 minutes |
| 39. Vidaza (Azacytidine) 25mg/ml (25,000 ppm) | >240 minutes |
| 40. Vinblastine Sulfate, 1mg/ml (1,000 ppm) | >240 minutes |
| 41. Vincristine Sulfate 1mg/ml (1,000 ppm) | >240 minutes |
| 42. Zoledronic Acid, 0.8mg/ml (800 ppm) | >240 minutes |
| Other Drugs, Fentanyl and Gastric Acid Concentration Minimum Breakthrough detection time in Minutes | |
| 1. Cytovene (Ganciclovir), (10,000ppm) | >240 minutes |
| 2. Retrovir 10mg/ml (10,000 ppm) | >240 minutes |
| 3. Triclosan, 3mg/ml (3,000 ppm) | >240 minutes |
| 4. Fentanyl Citrate Injection 100mcg/2ml | >240 minutes |
| 5. Simulated Gastric Acid | >240 minutes |

The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time.

Carmustine (BCNU) (3.3mg/ml)- Minimum Breakthrough detection time 22.0 minutes.

Thiotepa (10ug/ml) – Minimum Breakthrough detection time 34.2 minutes.

WARNING: Not for use with Carmustine and ThioTepa

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

| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|
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**ECO Medi Glove Sdn. Bhd.** (815262-D)

Darul Ridzijan, MALAYSIA ak Darul Ridzuan. MALAYSIA

E-mail : `[e-mail]` Website: `www.ecomediglove.com.my

TEL [phone]

**SST NO.: A11-1808-21015730**

FAX [phone]

## 510(K) Summary K233560

## Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid

### 1.0 Submitter:

| Company Name | : | ECO Medi Glove Sdn. Bhd. |
|------------------|---|---------------------------------------------------------------------------------------------------------------------------|
| Company Address | : | Lot 23826, Jalan Tembaga Kuning,<br>Kamunting Raya Industrial Estate,<br>34600 Taiping, Perak Darul Ridzuan,<br>Malaysia. |
| Contact Person | : | Mr. Suresh Kumar Sivalingam |
| Telephone | : | [phone] |
| Fax | : | [phone] |
| Email | : | [e-mail] |
| Preparation Date | : | 26th February 2024 |

### Name of the Device 3.0

2.0

Trade Name / Proprietary Name: Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid

Device Name: Low Dermatitis Nitrile Patient Examination gloves.

Device Classification Name: Non-Powdered Patient Examination Glove

Device Regulation Number: 21 CFR 880.6250

Device Class: Class I.

Product Code: LZA, LZC, QDO and OPJ

{6}------------------------------------------------

Plant 1 : Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA
Plant 2 : Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA
E-mail : [[e-mail]](mailto:[e-mail]) Website: [www.ecomediglove.com.my](http://www.ecomediglove.com.my)

TEL [phone]

FAX [phone]

### 4.0 Identification of The Legally Marketed Device:

Predicate Device: K181066, Powder Free Examination Glove (Blue) with Low Dermatitis Claim and with tested for use with Chemotherapy Drugs Claims.

Predicate Device Manufacturer: ECO Medi Glove Sdn. Bhd.

Reference Predicate: K202622, Halyard Lavender, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Reference Device Manufacturer: O & M Halyard, Inc.

This reference predicate is being used to support additional chemotherapy and other drugs that were not tested in the predicate.

### Device Description 5.0

The subject device in this 510(k) Notification is Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid. The subject device is a patient examination glove made from nitrile latex compound, Blue color, powder-free, and non-sterile (Per 21 CFR 880.6250, class I) and come in eight sizes (XXS, XS, S, M, L, XL, and XXL). The device meets all the specifications in ASTM D6319-19, the Standard Specification for Nitrile Examination Gloves and Modified Draize Test. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs, fentanyl, and Gastric Acid.

### 6.0 Indications for Use

Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid is a disposable device intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use.

In addition, these gloves were tested for use with Chemotherapy drugs, Fentanyl, and gastric acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

{7}------------------------------------------------

Plant 1 : Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA

Plant 2 : Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA

E-mail : [e-mail] Website: www.ecomediglove.com.my

TEL [phone]

FAX [phone]

SST NO. : A11-1808-21015730

| No. | Chemotherapy Drug Concentration | Minimum Breakthrough<br>detection time in Minutes |
|-----|------------------------------------------------------|---------------------------------------------------|
| 1 | Bendamustine HCl 5mg/ml (5,000ppm) | >240 minutes |
| 2 | Bleomycin Sulfate 15mg/ml (15,000ppm) | >240 minutes |
| 3 | Busulfan 6mg/ml (6,000 ppm) | >240 minutes |
| 4 | Carboplatin 10mg/ml (10,000 ppm) | >240 minutes |
| 5 | Carfilzomib 2mg/ml (2,000ppm) | >240 minutes |
| 6 | Carmustine 3.3mg/ml (3,300 ppm) | 22.0 minutes |
| 7 | Cetuximab 2mg/ml (2,000 ppm) | >240 minutes |
| 8 | Cisplatin 1mg/ml (1,000ppm) | >240 minutes |
| 9 | Cladribine 1mg/ml (1,000ppm) | >240 minutes |
| 10 | Cyclophosphamide, 20 mg/ml (20,000ppm) | >240 minutes |
| 11 | Cytarabine (Cytosine), (100,000ppm) | >240 minutes |
| 12 | Dacarbazine, 10mg/ml (10,000ppm) | >240 minutes |
| 13 | Daunorubicin, HCI, 5mg/ml (5,000 ppm) | >240 minutes |
| 14 | Decitabine, 5mg/ml (5,000 ppm) | >240 minutes |
| 15 | Docetaxel 10mg/ml (10,000ppm) | >240 minutes |
| 16 | Doxorubicin HCI, 2mg/ml (2,000 ppm) | >240 minutes |
| 17 | Epirubicin HCl, 2mg/ml (2,000 ppm) | >240 minutes |
| 18 | Etoposide, 20mg/ml (20,000 ppm) | >240 minutes |
| 19 | Fludarabine Phosphate, 25mg/ml (25,000 ppm) | >240 minutes |
| 20 | Fluorouracil, 50 mg/ml (50,000 ppm) | >240 minutes |
| 21 | Gemcitabine, HCI, 38mg/ml (38,000 ppm) | >240 minutes |
| 22 | Idarubicin HCI, 1mg/ml (1,000ppm) | >240 minutes |
| 23 | Ifosfamide, 50mg/ml (50,000 ppm) | >240 minutes |
| 24 | Irinotecan, HCI, 20mg/ml (20,000ppm) | >240 minutes |
| 25 | Mechlorethamine HCl, 1 mg/ml (1,000 ppm) | >240 minutes |
| 26 | Melphalan HCI, 5mg/ml (5,000 ppm) | >240 minutes |
| 27 | Methotrexate, 25mg/ml (25,000 ppm) | >240 minutes |
| 28 | Mitomycin C, 0.5mg/ml (500 ppm) | >240 minutes |
| 29 | Mitoxantrone HCI, 2mg/ml (2,000 ppm) | >240 minutes |
| 30 | Oxaliplatin, 5mg/ml (5,000ppm) | >240 minutes |
| 31 | Paclitaxel, 6mg/ml (6,000ppm) | >240 minutes |
| 32 | Paraplatin, 10mg/ml (10,000 ppm) | >240 minutes |
| 33 | Pemetrexed, 25mg/ml (25,000 ppm) | >240 minutes |
| 34 | Raltitrexed, 0.5mg/ml (500 ppm) | >240 minutes |
| 35 | Thiotepa, 10mg/ml (10,000 ppm) | 34.2 minutes |
| 36 | Topotecan, 1mg/ml (1,000 ppm) | >240 minutes |
| No. | Chemotherapy Drug Concentration | Minimum Breakthrough<br>detection time in Minutes |
| 38 | Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 minutes |
| 39 | Vidaza (Azacytidine) 25mg/ml (25,000 ppm) | >240 minutes |
| 40 | Vinblastine Sulfate, 1mg/ml (1,000 ppm) | >240 minutes |
| 41 | Vincristine Sulfate 1mg/ml (1,000 ppm) | >240 minutes |
| 42 | Zoledronic Acid, 0.8mg/ml (800 ppm) | >240 minutes |
| No. | Other Drugs, Fentanyl and Gastric Acid Concentration | Minimum Breakthrough<br>detection time in Minutes |
| 1 | Cytovene (Ganciclovir), 10,000ppm) | >240 minutes |
| 2 | Retrovir 10mg/ml (10,000 ppm) | >240 minutes |
| 3 | Triclosan, 3mg/ml (3,000 ppm) | >240 minutes |
| 4 | Fentanyl Citrate Injection<br>100mcg/2ml | >240 minutes |
| 5 | Simulated Gastric Acid | >240 minutes |

{8}------------------------------------------------

g. Perak Darul Ridzuan. MALAYSIA

00 Taiping. Perak Darul Ridzuan. MALAYSIA

E-mail : [[e-mail]](mailto:[e-mail]) Website: [www.ecomediglove.com.my](http://www.ecomediglove.com.my)

**SST NO.:** A11-1808-21015730

The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time.

Carmustine (BCNU) (3.3mg/ml)- Minimum Breakthrough detection time 22.0 minutes. Thiotepa (10ug/ml) - Minimum Breakthrough detection time 34.2 minutes.

WARNING: Not for use with Carmustine and ThioTepa

{9}------------------------------------------------

aiping. Perak Darul Ridzuan. MALAYSIA

4600 Taiping. Perak Darul Ridzuan. MALAYSIA

ecomedialove.com.my

TEL [phone]

SST NO. : A11-1808-21015730

FAX [phone]

## 7.0 Summary of the Technological Characteristics

# Comparison of Proposed and Predicate Devices

| Characteristics | Acceptance Criteria | Subject Device<br>Powder Free Nitrile<br>Examination Glove Blue<br>with Low Dermatitis<br>Potential Claim, Tested for<br>use with Chemotherapy<br>Drugs, Fentanyl and<br>Gastric Acid | Predicate Device<br>Powder Free Examination<br>Gloves (Blue) with Low<br>Dermatitis Claim and with<br>Tested for use with<br>Chemotherapy Drugs<br>Claims<br>K181066 | Comparison<br>Analysis |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZA, LZC, QDO and OPJ | LZA, LZC, QDO and OPJ | LZA, LZC | The subject device<br>and predicate device<br>have differences<br>with the addition of<br>QDO & OPJ for the<br>subject device. |
| Regulation<br>Number | 880.6250 | 880.6250 | 880.6250 | Same |
| Device<br>Classification | Class 1 | Class 1 | Class 1 | Same |
| Intended use | A powder-free patient<br>examination glove is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand or<br>finger to prevent<br>contamination between patient<br>and examiner. The device is<br>for over-the-counter use. | A powder-free patient<br>examination glove is a<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand<br>or finger to prevent<br>contamination between<br>patient and examiner. The<br>device is for over-the-<br>counter use. | A powder-free patient<br>examination glove is a<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand<br>or finger to prevent<br>contamination between<br>patient and examiner. The<br>device is for over-the-counter<br>use. | Same |
| Material use | Nitrile compound | Nitrile compound | Nitrile compound | Same |
| Color | Blue | Blue | Blue | Same |
| Sterility | Non sterile | Non sterile | Non sterile | Same |
| Single use | Single use | Single use | Single use | Same |
| Surface | Finger Textured | Finger Textured | Finger Textured | Same |
| Cuffing Beading | Rolled Beading | Rolled Beading | Rolled Beading | Same |
| Design | Ambidextrous | Ambidextrous | Ambidextrous | Same |

{10}------------------------------------------------

# ECO Medi Glove Sdn. Bhd. (815262-D)

Plant 1 : Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA

Plant 2 : Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA

E-mail : [e-mail] Website: www.ecomediglove.com.my

TEL [phone]

FAX [phone]

SST NO. : A11-1808-21015730

| Characteristics | Acceptance Criteria | Subject Device<br>Powder Free Nitrile<br>Examination Glove Blue<br>with Low Dermatitis<br>Potential Claim, Tested<br>for use with<br>Chemotherapy Drugs,<br>Fentanyl and Gastric<br>Acid | Predicate Device<br>Powder Free Examination<br>Gloves (Blue) with Low<br>Dermatitis Claim and with<br>Tested for use with<br>Chemotherapy<br>Drugs Claims<br>K181066 | Comparison<br>Analysis | | | | | | | |
|-------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------|-------------------|----------------------------------|--------------------------------|------|
| Dimensions | | | | | | | | | | | |
| Reference Standard<br>ASTN D6319-19 | Size<br>Length<br>(min)<br>Width<br>(±10mm) | Size<br>Length<br>(min)<br>Width<br>(±10mm) | Size<br>Length<br>(min)<br>Width<br>(±10mm) | Different:<br><br>Additional sizes<br>XXS, XS, and XXL<br>were added to the<br>subject device.<br><br>The XXS and XS<br>are applicable for<br>smaller hand sizes<br>users.<br><br>The XXL is<br>applicable for<br>larger hand sizes<br>users. | | | | | | | |
| | XXS<br>XS<br>S<br>M<br>L<br>XL<br>XXL | Not indicated<br>220mm<br>220mm<br>230mm<br>230mm<br>230mm<br>230mm | Not indicated<br>70mm<br>80mm<br>95mm<br>110mm<br>120mm<br>130mm | | XXS<br>XS<br>S<br>M<br>L<br>XL<br>XXL | 220mm<br>220mm<br>220mm<br>230mm<br>230mm<br>230mm<br>230mm | 65mm<br>70mm<br>80mm<br>95mm<br>110mm<br>120mm<br>130mm | S<br>M<br>L<br>XL | 220mm<br>230mm<br>230mm<br>230mm | 85mm<br>95mm<br>105mm<br>115mm | |
| | Thickness<br>Palm<br>Finger Tip | Min 0.05mm<br>Min 0.05mm | Thickness<br>Palm<br>Finger Tip | Min 0.05mm<br>Min 0.05mm | Thickness<br>Palm<br>Finger Tip | Min 0.05mm<br>Min 0.05mm | | | | | |
| | | | | | | | | | | | Same |
| | | | | | | | | | | | |
| | | | Before<br>Ageing<br>After<br>Aging at<br>70°C for<br>168 hrs<br>@ 100°C<br>for 22 hrs | Before<br>Ageing<br>After<br>Aging at<br>70°C for<br>168 hrs<br>@ 100°C<br>for 22 hrs | Before<br>Ageing<br>After<br>Aging at<br>70°C for<br>168 hrs<br>@ 100°C<br>for 22 hrs | | | | | | |
| | Tensile<br>Strength<br>(MPa)<br>Ultimate<br>Elongation | 14min<br>500min | 14min<br>400min | Tensile<br>Strength<br>(MPa)<br>Ultimate<br>Elongation | 14min<br>500min | 14min<br>400min | Tensile<br>Strength<br>(MPa)<br>Ultimate<br>Elongation | 14min<br>500min | 14min<br>400min | | |

{11}------------------------------------------------

# · (815262-D)

Plant 1 : Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA

Plant 2 : Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA

E-mail : [e-mail] Website: www.ecomediglove.com.my

TEL [phone]

SST NO. : A11-1808-21015730

FAX [phone]

| Characteristics | Acceptance<br>Criteria | Subject Device<br>Powder Free Nitrile<br>Examination Glove Blue<br>with Low Dermatitis<br>Potential Claim, Tested for<br>use with Chemotherapy<br>Drugs, Fentanyl and<br>Gastric Acid | Predicate Device<br>Powder Free Examination<br>Gloves (Blue) with Low<br>Dermatitis Claim and<br>with Tested for use with<br>Chemotherapy Drugs<br>Claims<br>K181066 | Comparison<br>Analysis |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Freedom from Pinholes<br>ASTM D5151-19 | AQL 2.5 Inspection<br>Level G-1 | Passes AQL 1.5 Inspection<br>Level: G1 | Passes AQL 1.5 Inspection<br>Level: G1 | Same |
| Residual Powder<br>ASTM D6124-06 | ≤2.0 mg/glove | ≤2 mg/glove | ≤2 mg/glove | Same |
| Dermal Irritation<br>ISO 10993-23:2021 | Under the conditions<br>of the study, the<br>device is not an<br>irritant. | Under the conditions of this<br>study, the test article was a non-<br>irritant. | Under the conditions of this<br>study, the test article was a<br>non-irritant. | Same |
| Dermal Sensitization<br>ISO 10993-10: 2021 | Under the conditions<br>of the study, the<br>device is not a<br>sensitizer. | Under the conditions of this<br>study, the test article was a non-<br>sensitizer. | Under the conditions of this<br>study, the test article was a<br>non-sensitizer. | Same |
| Acute Systemic Toxicity<br>ISO 10993-11 | Under the conditions<br>of this study, the test<br>article does not induce<br>systemic toxicity. | Under the conditions of this<br>study, the test article did not<br>induce any systemic toxicity. | Under the conditions of this<br>study, the test article did not<br>induce any systemic toxicity. | Same |
| Low Dermatitis Potential<br>claim<br>Modified Draize 95 Test | No clinical evidence<br>presence of residual<br>chemical additives<br>that may induce type<br>IV allergy in human<br>subject. | There was no clinical evidence<br>of the presence of residual<br>chemical additives at the level<br>that may induce type IV allergy<br>in the un-sensitized general user<br>population in the test articles. | There was no clinical evidence<br>of the presence of residual<br>chemical additives at the level<br>that may induce type IV<br>allergy in the un-sensitized<br>general user population in the<br>test articles. | Same |

{12}------------------------------------------------

# (815262-D)

Plant 1 : Lot 32586, No. 118, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA

Plant 2 : Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA

E-mail : [e-mail] Website: www.ecomediglove.com.my

TEL [phone]

SST NO. : A11-1808-21015730

| FAX [phone] | |
|--------------------|--|

| No. | Characteristics | Acceptance<br>Criteria | Subject Device<br>Powder Free Nitrile<br>Examination Glove<br>Blue with Low<br>Dermatitis<br>Potential Claim,<br>Tested for use with<br>Chemotherapy<br>Drugs, Fentanyl<br>and Gastric Acid | Reference Predicate<br>Halyard Lavender,<br>Powder-Free<br>Exam Gloves<br>Tested for Use<br>with<br>Chemotherapy<br>Drugs and<br>Fentanyl Citrate<br>K202622 | Predicate Device<br>Powder Free<br>Examination<br>Gloves (Blue) with<br>Low Dermatitis<br>Claim and with<br>Tested for use with<br>Chemotherapy<br>Drugs Claims<br>K181066 | Comparison<br>Analysis |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | Chemotherapy Drug Permeation | | | Minimum Breakthrough detection time in Minutes | | |
| Test | | | | | | |
| No. | Chemotherapy<br>Drug/Concentration | | | | | |
| 1 | Bendamustine HCl<br>5mg/ml (5,000ppm) | | >240 minutes | >240 minutes | / | Same |
| 2 | Bleomycin Sulfate<br>15mg/ml (15,000ppm) | | >240 minutes | >240 minutes | / | Same |
| 3 | Busulfan<br>6mg/ml (6,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 4 | Carboplatin<br>10mg/ml (10,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 5 | Carfilzomib<br>2mg/ml (2,000ppm) | | >240 minutes | >240 minutes | / | Same |
| 6 | Carmustine<br>3.3mg/ml (3,300 ppm) | | 22.0 minutes | 0.3 minutes | 12.9 minutes | Similar |
| 7 | Cetuximab<br>2mg/ml (2,000 ppm) | Standards<br>Practice for<br>Assessment of | >240 minutes | >240 minutes | / | Same |
| 8 | Cisplatin<br>1mg/ml (1,000ppm) | resistance of<br>Medical Glove<br>to Permeation | >240 minutes | >240 minutes | >240 minutes | Same |
| 9 | Cladribine<br>1mg/ml (1,000ppm) | by<br>Chemotherapy | >240 minutes | >240 minutes | / | Same |
| 10 | Cyclophosphamide<br>20 mg/ml (20,000ppm) | drugs<br>ASM D6978-<br>05 | >240 minutes | >240 minutes | >240 minutes | Same |
| 11 | Cytarabine (Cytosine)<br>(100,000ppm) | | >240 minutes | >240 minutes | / | Same |
| 12 | Dacarbazine<br>10mg/ml (10,000ppm) | | >240 minutes | >240 minutes | / | Same |
| 13 | Daunorubicin HCI<br>5mg/ml (5,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 14 | Decitabine<br>5mg/ml (5,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 15 | Docetaxel<br>10mg/ml (10,000ppm) | | >240 minutes | >240 minutes | / | Same |
| 16 | Doxorubicin HCI<br>2mg/ml (2,000 ppm) | | >240 minutes | >240 minutes | >240 minutes | Same |
| 17 | Epirubicin HCl<br>2mg/ml (2,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 18 | Etoposide<br>20mg/ml (20,000 ppm) | | >240 minutes | >240 minutes | >240 minutes | Same |
| 19 | Fludarabine Phosphate<br>25mg/ml (25,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 20 | Fluorouracil<br>50 mg/ml (50,000 ppm) | | >240 minutes | >240 minutes | >240 minutes | Same |
| 21 | Gemcitabine, HCI<br>38mg/ml (38,000 ppm) | | >240 minutes | >240 minutes | / | Same |
| 22 | Idarubicin HCI<br>1mg/ml (1,000ppm) | | >240 minutes…