Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff

K251319 · Hartalega NGC Sdn. Bhd. · LZA · Jul 30, 2025 · General Hospital

Device Facts

• Record ID: K251319
• Device Name: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff
• Applicant: Hartalega NGC Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Jul 30, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) - Extended Cuff, is a sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Sterile, blue, powder-free nitrile examination gloves; single-use; ambidextrous. Designed to prevent cross-contamination between patient and examiner. Tested for permeation resistance against various chemotherapy drugs and fentanyl citrate per ASTM D6978. Used in clinical settings by healthcare professionals. Provides a physical barrier; protects the wearer from exposure to hazardous drugs. Extended cuff version available for increased coverage. Output is the physical barrier provided by the glove material.

Clinical Evidence

No clinical data. Bench testing only. Compliance demonstrated via ASTM standards for physical properties (tensile strength, elongation), integrity (freedom from holes), residual powder, and biocompatibility (ISO 10993-23, 10993-10, 10993-11). Permeation resistance tested per ASTM D6978.

Technological Characteristics

Material: Nitrile. Form factor: Sterile, powder-free, blue, ambidextrous. Dimensions: Meets ASTM D6319-19 (2023). Sterilization: Radiation (10^-6 SAL). Connectivity: None. Software: None.

Indications for Use

Indicated for use as a sterile, disposable, patient examination glove worn on the examiner's hand to prevent contamination between patient and examiner. Tested for resistance to permeation by specific chemotherapy drugs and fentanyl citrate per ASTM D6978.

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

• Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K201531)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

July 30, 2025

Hartalega NGC Sdn. Bhd.
Mahalia Liyana Mat Harun
Manager - Regulatory Affairs
No. 1, Persiaran Tanjung, Kawasan Perindustrian Tanjung
Sepang, Selangor Darul Ehsan 43900
Malaysia

Re: K251319

Trade/Device Name: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff

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: July 3, 2025

Received: July 3, 2025

Dear Mahalia Liyana Mat Harun:

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

{1}

K251319 - Mahalia Liyana Mat Harun
Page 2

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 (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 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.

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 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

{2}

K251319 - Mahalia Liyana Mat Harun
Page 3

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

{3}

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)
K251319

Device Name
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue);
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) - Extended Cuff

Indications for Use (Describe)
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) - Extended Cuff, is a sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
| --- | --- |
| Carmustine (3.3 mg/ml) | 38.3 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin HCl (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mytomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 78.6 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Vidaza (5-Azacytidine), 25 mg/ml | >240 |
| Busulfan, 6 mg/ml | >240 |
| Carboplatin, 10 mg/ml | >240 |
| Docetaxel, 10 mg/ml | >240 |
| Epirubicin HCl, 2 mg/ml | >240 |
| Gemcitabine HCl, 38 mg/ml | >240 |
| Ifosfamide, 50 mg/ml | >240 |
| Irinotecan, 20 mg/ml | >240 |
| Mitoxantrone HCl, 2 mg/ml | >240 |
| Oxaliplatin, 5 mg/ml | >240 |
| Vinorelbine, 10 mg/ml | >240 |

Fentanyl Citrate and Concentration
Minimum Breakthrough Detection Time in Minutes
Fentanyl Citrate Injection (100mcg/2ml)
>240

Caution: Testing showed a minimum breakthrough time of 38.3 minutes with Carmustine and 78.6 minutes with Thiotepa.
Warning: Do not use with Carmustine

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)

FORM FDA 3881 (8/23)
Page 1 of 2
PSC Publishing Services [phone]

{4}

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

{5}

K251319

# 510(k) SUMMARY FOR K251319

(The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92)

## APPLICANT INFORMATION

Date Prepared : July 29, 2025
Name : Hartalega NGC Sdn. Bhd.
Address : No. 1, Persiaran Tanjung,
Kawasan Perindustrian Tanjung,
43900 Sepang, Selangor Darul Ehsan,
Malaysia
Establishment Registration Number : 3011200663

## CORRESPONDENT AND/OR PREPARER INFORMATION

Contact Name : Mahalia Liyana Mat Harun
Contact Title : Manager – Regulatory Affairs
Phone Number : (603) 8707 3000
Fax Number : (603) 3271 0135
Contact Email : [e-mail]

## DEVICE IDENTIFICATION

Common Name of the Device : Examination Glove
Trade Name (Proprietary Name) : Sterile Nitrile Powder Free Examination Glove Tested for Use with
Chemotherapy Drugs and Fentanyl Citrate (Blue),
Sterile Nitrile Powder Free Examination Glove Tested for Use with
Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff
Device Class : 1
Product Code : LZA, LZC, QDO, OPJ
Regulation Number : 21 CFR 880.6250
Reason for 510(k) Submission : New device

Page 1 of 8

{6}

K251319

# PREDICATE DEVICE INFORMATION

510(k) Number : K201531
Manufacturer : Hartalega Sdn. Bhd.
Trade Name (Proprietary Name) : Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Device Class : 1
Product Code : LZA, LZC
Regulation Number : 21 CFR 880.6250

# DESCRIPTION OF THE DEVICE:

Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff, are disposable, single-use, sterile, blue-colored, and powder-free examination gloves made from nitrile latex.

# INDICATIONS FOR USE:

Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff, is a sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
| --- | --- |
| Carmustine (3.3 mg/ml) | 38.3 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin HCl (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 78.6 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Vidaza (5-Azacytidine), 25 mg/ml | >240 |

Page 2 of 8

{7}

K251319

| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
| --- | --- |
| Busulfan, 6 mg/ml | >240 |
| Carboplatin, 10 mg/ml | >240 |
| Docetaxel, 10 mg/ml | >240 |
| Epirubicin HCl, 2 mg/ml | >240 |
| Gemcitabine HCl, 38 mg/ml | >240 |
| Ifosfamide, 50 mg/ml | >240 |
| Irinotecan, 20 mg/ml | >240 |
| Mitoxantrone HCl, 2 mg/ml | >240 |
| Oxaliplatin, 5 mg/ml | >240 |
| Vinorelbine, 10 mg/ml | >240 |

Caution: Testing showed a minimum breakthrough time of 38.3 minutes with Carmustine and 78.6 minutes with Thiotepa.

Warning: Do not use with Carmustine.

| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
| --- | --- |
| Fentanyl Citrate Injection, 100 mcg/2ml | >240 |

Page 3 of 8

{8}

K251319

TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE:

| Characteristics and Parameters | Subject Device (1) | Subject Device (2) | Predicate Device (K201531) | Discussion |
| --- | --- | --- | --- | --- |
| Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff |
| Trade Name | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Similar |
| Applicant | Hartalega NGC Sdn. Bhd. | Hartalega Sdn. Bhd. | Different |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO | Same |
| Classification | 1 | 1 | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Regulation Name | Non-Powdered Patient Examination Glove | Non-Powdered Patient Examination Glove | Same |
| Indications for Use | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) - Extended Cuff, is a sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | A sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate. | Same |
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes | The performance level for Carmustine and Thiotepa between subject device and predicate device is comparable.
An additional 11 chemotherapy drugs were tested on the subject device |
| Carmustine (3.3 mg/ml) | 38.3 | Carmustine (3.3 mg/ml) | 26.3 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 | Cisplatin (1.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 | Cyclophosphamide (20.0 mg/ml) | >240 |
| Doxorubicin HCl (2.0 mg/ml) | >240 | Dacarbazine (10.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 | Doxorubicin HCl (2.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 | Etoposide (20.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 | Fluorouracil (50.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 | Methotrexate (25.0 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 | Mitomycin C (0.5 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 78.6 | Paclitaxel (6.0 mg/ml) | >240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 | Vincristine Sulfate (1.0 mg/ml) | >240 |
| Vidaza (5-Azacytidine), 25 mg/ml | >240 | Vidaza (5-Azacytidine), 25 mg/ml | >240 |
| Busulfan, 6 mg/ml | >240 | Busulfan, 6 mg/ml | >240 |
| Carboplatin, 10 mg/ml | >240 | Carboplatin, 10 mg/ml | >240 |
| Docetaxel, 10 mg/ml | >240 | Docetaxel, 10 mg/ml | >240 |
| Epirubicin HCl, 2 mg/ml | >240 | Epirubicin HCl, 2 mg/ml | >240 |
| Gemcitabine HCl, 38 mg/ml | >240 | Gemcitabine HCl, 38 mg/ml | >240 |
| Ifosfamide, 50 mg/ml | >240 | Ifosfamide, 50 mg/ml | >240 |
| Irinotecan, 20 mg/ml | >240 | Irinotecan, 20 mg/ml | >240 |
| Mitoxantrone HCl, 2 mg/ml | >240 | Mitoxantrone HCl, 2 mg/ml | >240 |

Page 4 of 8

{9}

K251319

| Characteristics and Parameters | Subject Device (1) | | Subject Device (2) | | Predicate Device (K201531) | | Discussion |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff | Thiotepa (10.0 mg/ml) | Vincristine Sulfate (1.0 mg/ml) | 97.1 | 240 | |
| | Oxaliplatin, 5 mg/ml | > 240 | Caution: Please note that Carmustine and Thiotepa have extremely low permeation times of 26.3 minutes and 97.1 minutes respectively.
Warning: Do not use with Carmustine. | Caution: Please note that Carmustine and Thiotepa have extremely low permeation times of 26.3 minutes and 97.1 minutes respectively.
Warning: Do not use with Carmustine and Thiotepa | | | |
| | Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes | Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes | Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes | Same |
| | Fentanyl Citrate Injection (100mcg/2ml) | > 240 | Fentanyl Citrate Injection (100mcg/2ml) | > 240 | | | |
| | | | | | | | |
| Type of use | Over the counter use | | Over the counter use | | Same | | |
| Materials | Nitrile | | Nitrile | | Same | | |
| Color | Blue | | Blue | | Same | | |
| Design | • Single Use
• Sterile
• Powder-Free
• Ambidextrous | | • Single Use
• Sterile
• Powder-Free
• Ambidextrous | | Same | | |
| Sterility | Sterile | | Sterile | | Same | | |
| Sterilization | Radiation | | Radiation | | Same | | |
| Sterility Assurance Level (SAL) | 10^{6} SAL | | 10^{6} SAL | | Same | | |
| Freedom from holes | Meets ASTM D5151-19 (2023):
AQL 1.5 | | Meets ASTM D5151-06(2015):
AQL 1.5 | | Similar | | |
| Length | Meets ASTM D6319-19 (2023):
Overall Length: ≥ 230 mm | Meets ASTM D6319-19 (2023):
Overall Length: ≥ 260 mm | Meets ASTM D6319-10 (2015):
Overall Length: ≥ 230 mm | Meets ASTM D6319-10 (2015):
Overall Length: ≥ 230 mm | Both subject devices meet the overall length specification in accordance with ASTM D6319. Subject Device (2) features an extended cuff design, with a minimum length of 260 mm, compared to 230 mm for the predicate device. This dimensional difference does not impact the safety or performance of the subject device, as all devices comply with | | |

Page 5 of 8

{10}

K251319

| Characteristics and Parameters | Subject Device (1) | | Subject Device (2) | | Predicate Device (K201531) | Discussion |
| --- | --- | --- | --- | --- | --- | --- |
| | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff | | |
| | | | | | | applicable standard requirements. |
| Width | Meets ASTM D6319-19 (2023):
XS: 60 – 80 (mm)
S: 70 – 90 (mm)
M: 85 – 105 (mm)
L: 100 – 120 (mm)
XL: 110 – 130 (mm) | | Meets ASTM D6319-10 (2015):
XS: 60 – 80 (mm)
S: 70 – 90 (mm)
M: 85 – 105 (mm)
L: 100 – 120 (mm)
XL: 110 – 130 (mm) | | Similar | |
| Thickness | Meets ASTM D6319-19 (2023):
Palm Thickness: ≥ 0.05 mm
Finger Thickness: ≥ 0.05 mm | | Meets ASTM D6319-10 (2015):
Palm Thickness: ≥ 0.05 mm
Finger Thickness: ≥ 0.05 mm | | Similar | |
| Physical Properties | Meets ASTM D6319-19 (2023):
Tensile Strength Before Aging: ≥ 14 MPa
Tensile Strength After Aging: ≥ 14 MPa
Ultimate Elongation Before Aging: ≥ 500 %
Ultimate Elongation After Aging: ≥ 400 % | | Meets ASTM D6319-10 (2015)
Tensile Strength Before Aging: ≥ 14 MPa
Tensile Strength After Aging: ≥ 14 MPa
Ultimate Elongation Before Aging: ≥ 500 %
Ultimate Elongation After Aging: ≥ 400 % | | Similar | |
| Powder residual | Meets ASTM D6319-19 (2023) & ASTM D6124-06 (2017):
Residual Powder: ≤ 2 mg per glove | | Meets ASTM D6124-06 (2017):
Residual Powder: ≤ 2 mg per glove | | Similar | |
| Primary Skin Irritation ISO 10993-23 | Under the conditions of the study, the device is not an irritant | | Under the conditions of the study, the device is not an irritant | | Same | |
| Dermal Sensitization ISO 10993-10 | Under the conditions of the study, the device is not a sensitizer | | Under the conditions of the study, the device is not a sensitizer | | Same | |
| Acute Systemic Toxicity Test ISO 10993-11 | Under the conditions of this study, the device showed no evidence of acute systemic toxicity | | Under the conditions of this study, the device showed no evidence of acute systemic toxicity | | Same | |

Page 6 of 8

{11}

K251319

# SUMMARY OF NON-CLINICAL TESTING:

Non-clinical testing was performed to verify that the subject devices meet the acceptance criteria of the performance test and all design specifications. The test results demonstrated that the subject device complies with the following standards as shown below.

| Test | Purpose | Criteria | Result |
| --- | --- | --- | --- |
| Standard Test Method for Detection of Holes in Medical Gloves ASTM D5151-19(R2023) | To demonstrate glove integrity | Freedom from holes
AQL 1.5% | Pass |
| Standard Test Method for Residual Powder on Medical Gloves ASTM D6124-06(R2022) | To demonstrate the gloves are ‘powder free’ | Average less than 2 mg/glove | Pass |
| Dimensional Conformance ASTM D6319(R2023) | 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% | Pass |
| Tensile Performance ASTM D6319(R2023) | 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% | 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 Systemic Toxicity ISO 10993-11 | To demonstrate low acute systemic toxicity | Under the conditions of the study, no acute systemic toxicity. | Pass |
| 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:
Carmustine (3.3 mg/ml)
Cisplatin (1 mg/ml)
Cyclophosphamide (20 mg/ml)
Dacarbazine (10 mg/ml)
Doxorubicin HCl (2 mg/ml)
Etoposide (20 mg/ml)
Fluorouracil (50 mg/ml)
Methotrexate (25 mg/ml)
Mitomycin C (0.5 mg/ml)
Paclitaxel (6 mg/ml)
Thiotepa (10 mg/ml)
Vincristine Sulfate (1 mg/ml)
Vidaza (5-Azacytidine), 25 mg/ml
Busulfan, 6 mg/ml
Carboplatin, 10 mg/ml
Docetaxel, 10 mg/ml
Epirubicin HCl, 2 mg/ml | N/A | Carmustine
Minimum breakthrough time: 38.3 minutes

Thiotepa
Minimum breakthrough time: 78.6 minutes

No breakthrough detected during 240-minute test duration for remaining tested chemotherapy drugs and fentanyl citrate |

Page 7 of 8

{12}

K251319

| Test | Purpose | Criteria | Result |
| --- | --- | --- | --- |
| | Gemcitabine HCl, 38 mg/ml
Ifosfamide, 50 mg/ml
Irinotecan, 20 mg/ml
Mitoxantrone HCl, 2 mg/ml
Oxaliplatin, 5 mg/ml
Vinorelbine, 10 mg/ml
Fentanyl Citrate Injection, 100 mcg/2mL | | |

## CLINICAL PERFORMANCE DATA:

Not applicable.

## CONCLUSION:

The conclusions drawn from the non-clinical testing demonstrates that the subject devices (Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff) are as safe, as effective and perform as well as or better than the legally marketed predicate device K201531, Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue).

Page 8 of 8