← Product Code [LZA](/productcode/LZA) · K260867

# Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) (K260867)

_Hartalega NGC Sdn. Bhd. · LZA · Jun 17, 2026 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K260867

## Device Facts

- **Applicant:** Hartalega NGC Sdn. Bhd.
- **Product Code:** [LZA](/productcode/LZA.md)
- **Decision Date:** Jun 17, 2026
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for Use

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Blue) is a non-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. Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Black) is a non-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.

## Device Story

Disposable, non-sterile, powder-free nitrile examination gloves (blue and black variants). Used by healthcare professionals in clinical settings to prevent cross-contamination. Tested for permeation resistance against various chemotherapy drugs and fentanyl citrate per ASTM D6978. Provides a physical barrier; protects the wearer from exposure to hazardous drugs. Modification adds a 5-year shelf-life claim supported by real-time aging data. Healthcare providers use the gloves during patient examinations and drug handling; performance data (breakthrough times) informs safe handling practices and duration of use.

## Clinical Evidence

No clinical data required. Evidence consists of bench testing, including real-time 5-year shelf-life stability testing (ASTM D7160), physical property testing (ASTM D6319), barrier integrity (ASTM D5151), and chemotherapy drug/fentanyl citrate permeation testing (ASTM D6978).

## Technological Characteristics

Material: Nitrile latex. Form: Powder-free, ambidextrous, non-sterile. Standards: ASTM D6319 (dimensions, physical properties), ASTM D5151 (freedom from holes), ASTM D6124 (residual powder), ASTM D6978 (chemotherapy permeation). Shelf life: 5 years (real-time).

## Regulatory 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 Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Black) ([K200019](/device/K200019.md))

## Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

June 17, 2026

Hartalega NGC Sdn. Bhd
Nor Akmar Yusoff
Manager - Regulatory Affairs
Contact Address

Re: K260867

Trade/Device Name: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)

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: May 22, 2026

Received: May 22, 2026

Dear Nor Akmar Yusoff:

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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K260867 - Nor Akmar Yusoff

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

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K260867 - Nor Akmar Yusoff

Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

**BIFENG QIAN - S** FDA

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)

K260867

Device Name

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue);

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)

Indications for Use (Describe)

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Blue) is a non-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.

The list of Chemotherapy Drugs tested (with breakthrough time) are:

|  Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes  |
| --- | --- |
|  Carmustine (3.3 mg/ml) | 20.0  |
|  Cisplatin (1.0 mg/ml) | >240  |
|  Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240  |
|  Dacarbazine (10.0 mg/ml) | >240  |
|  Doxorubicin Hydrochloride (2.0 mg/ml) | >240  |
|  Etoposide (Toposar) (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 (Taxol) (6.0 mg/ml) | >240  |
|  Thiotepa (10.0 mg/ml) | 54.0  |
|  Vincristine Sulfate (1.0 mg/ml) | >240  |
|  5-Azacytidine (25.0 mg/ml) | >240  |
|  Carboplatin (10.0 mg/ml) | >240  |
|  Docetaxel (10 mg/ml) | >240  |
|  Epirubicin (2.0 mg/mL) | >240  |
|  Gemcitabine (38 mg/ml) | >240  |
|  Ifosfamide (50 mg/ml) | >240  |
|  Irinotecan (20 mg/ml) | >240  |
|  Mitoxantrone (2.0 mg/ml) | >240  |
|  Oncovin (1.0 mg/ml) | >240  |
|  Oxaliplatin (5 mg/ml) | >240  |
|  Vinorelbine (10 mg/ml) | >240  |

Caution: Testing showed a minimum breakthrough time of 20.0 minutes with Carmustine and 54.0 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  |

FORM FDA 3881 (8/23)

Page 1 of 3

PSC Publishing Services (301) 443-6740

EF

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Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Black) is a non-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.

The list of Chemotherapy Drugs tested (with breakthrough time) are:

|  Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes  |
| --- | --- |
|  Carmustine (3.3 mg/ml) | 25.0  |
|  Cisplatin (1.0 mg/ml) | >240  |
|  Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240  |
|  Dacarbazine (10.0 mg/ml) | >240  |
|  Doxorubicin Hydrochloride (2.0 mg/ml) | >240  |
|  Etoposide (Toposar) (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 (Taxol) (6.0 mg/ml) | >240  |
|  Thiotepa (10.0 mg/ml) | 55.7  |
|  Vincristine Sulfate (1.0 mg/ml) | >240  |
|  5-Azacytidine (25.0 mg/ml) | >240  |
|  Carboplatin (10.0 mg/ml) | >240  |
|  Docetaxel (10 mg/ml) | >240  |
|  Epirubicin (2.0 mg/mL) | >240  |
|  Gemcitabine (38 mg/ml) | >240  |
|  Ifosfamide (50 mg/ml) | >240  |
|  Irinotecan (20 mg/ml) | >240  |
|  Mitoxantrone (2.0 mg/ml) | >240  |
|  Oncovin (1.0 mg/ml) | >240  |
|  Oxaliplatin (5 mg/ml) | >240  |
|  Vinorelbine (10 mg/ml) | >240  |

Caution: Testing showed a minimum breakthrough time of 25.0 minutes with Carmustine and 55.7 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  |

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.

FORM FDA 3881 (8/23)

Page 2 of 3

PSC Publishing Services (301) 443-6740

EF

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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  
PRAStaff@fda.hhs.gov

*'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 3 of 3

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# 510(k) SUMMARY

FOR K260867

# NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH
CHEMOTHERAPY DRUG AND FENTANYL CITRATE (BLUE)

# NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH
CHEMOTHERAPY DRUG AND FENTANYL CITRATE (BLACK)

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

# SUBMITTER INFORMATION

Name : Hartalega NGC Sdn. Bhd.
Address : No. 1, Persiaran Tanjung,
Kawasan Perindustrian Tanjung,
43900 Sepang, Selangor Darul Ehsan,
Malaysia
Phone Number : (603) 8707 3000
Fax Number : (603) 6280 2533
Contact Person : Kuan Mun Leong
Date Prepared : February 27, 2026

# CORRESPONDENT AND/OR PREPARER INFORMATION

Contact Name : Nor Akmar Yusoff
Contact Title : Manager – Regulatory Affairs
Phone Number : (603) 8707 3000
Fax Number : (603) 6280 2533
Contact Email : akmar.yusoff@hartalega.com.my

# DEVICE IDENTIFICATION

Common Name of the Device : Examination Glove
Trade Name (Proprietary Name) : Nitrile Powder Free Examination Glove Tested for Use with
Chemotherapy Drug and Fentanyl Citrate (Blue);
Nitrile Powder Free Examination Glove Tested for Use with
Chemotherapy Drug and Fentanyl Citrate (Black)
Device Class : 1
Product Code : LZA, LZC, QDO, OPJ
Regulation Number : 21 CFR 880.6250

# PREDICATE DEVICE INFORMATION

510(k) Number : K200019
Manufacturer : Hartalega NGC Sdn. Bhd.
Trade Name (Proprietary Name) : Nitrile Powder Free Examination Glove Tested for Use with

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Chemotherapy Drug and Fentanyl Citrate (Blue);

Nitrile Powder Free Examination Glove Tested for Use with

Chemotherapy Drug and Fentanyl Citrate (Black)

Device Class : 1

Product Code : LZA, LZC, QDO

Regulation Number : 21 CFR 880.6250

## DESCRIPTION OF THE DEVICE:

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Blue) is a disposable single-use, non- sterile, blue-colored and powder-free examination glove made from nitrile latex. Gloves meet the specification of ASTM D6319 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978.

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Black) is a disposable single-use, non- sterile, black-colored and powder-free examination glove made from nitrile latex. Gloves meet the specification of ASTM D6319 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978.

## 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 Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Blue) and Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Black). Refer below table for detail:

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

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# INDICATIONS FOR USE:

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a non-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.

The list of Chemotherapy Drugs tested (with breakthrough time) are:

|  Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes  |
| --- | --- |
|  Carmustine (3.3 mg/ml) | 20.0  |
|  Cisplatin (1.0 mg/ml) | > 240  |
|  Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240  |
|  Dacarbazine (10.0 mg/ml) | > 240  |
|  Doxorubicin Hydrochloride (2.0 mg/ml) | > 240  |
|  Etoposide (Toposar) (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 (Taxol) (6.0 mg/ml) | > 240  |
|  Thiotepa (10.0 mg/ml) | 54.0  |
|  Vincristine Sulfate (1.0 mg/ml) | > 240  |
|  5-Azacytidine, 25 mg/ml | > 240  |
|  Carboplatin, 10 mg/ml | > 240  |
|  Docetaxel, 10 mg/ml | > 240  |
|  Epirubicin, 2 mg/ml | > 240  |
|  Gemcitabine, 38 mg/ml | > 240  |
|  Ifosfamide, 50 mg/ml | > 240  |
|  Irinotecan, 20 mg/ml | > 240  |
|  Mitoxantrone, 2 mg/ml | > 240  |
|  Oncovin, 1.0mg/ml | > 240  |
|  Oxaliplatin, 5 mg/ml | > 240  |
|  Vinorelbine, 10 mg/ml | > 240  |

Caution: Testing showed a minimum breakthrough time of 20.0 minutes with Carmustine and 54.0 minutes with Thiotepa.

Warning: Do not use with Carmustine.

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

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Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) is a non-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.

The list of Chemotherapy Drugs tested (with breakthrough time) are:

|  Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes  |
| --- | --- |
|  Carmustine (3.3 mg/ml) | 25.0  |
|  Cisplatin (1.0 mg/ml) | > 240  |
|  Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240  |
|  Dacarbazine (10.0 mg/ml) | > 240  |
|  Doxorubicin Hydrochloride (2.0 mg/ml) | > 240  |
|  Etoposide (Toposar) (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 (Taxol) (6.0 mg/ml) | > 240  |
|  Thiotepa (10.0 mg/ml) | 55.7  |
|  Vincristine Sulfate (1.0 mg/ml) | > 240  |
|  5-Azacytidine, 25 mg/ml | > 240  |
|  Carboplatin, 10 mg/ml | > 240  |
|  Docetaxel, 10 mg/ml | > 240  |
|  Epirubicin, 2 mg/ml | > 240  |
|  Gemcitabine, 38 mg/ml | > 240  |
|  Ifosfamide, 50 mg/ml | > 240  |
|  Irinotecan, 20 mg/ml | > 240  |
|  Mitoxantrone, 2 mg/ml | > 240  |
|  Oncovin, 1.0mg/ml | > 240  |
|  Oxaliplatin, 5 mg/ml | > 240  |
|  Vinorelbine, 10 mg/ml | > 240  |

Caution: Testing showed a minimum breakthrough time of 25.0 minutes with Carmustine and 55.7 minutes with Thiotepa.

Warning: Do not use with Carmustine.

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

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# TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE:

|  Characteristics and Parameters | Subject Device |   | Predicate Device (K200019) |   | Discussion  |
| --- | --- | --- | --- | --- | --- |
|  Trade Name | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Black) |   | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Black) |   | Same  |
|  Applicant | Hartalega NGC Sdn. Bhd. |   | Hartalega NGC Sdn. Bhd. |   | Same  |
|  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 | **Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Blue)** A non-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. |   | **Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Blue)** A non-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 Fentanyl Citrate Performance | **Chemotherapy Drug and Concentration** | **Minimum Breakthrough Detection Time in Minutes** | **Chemotherapy Drug and Concentration** | **Minimum Breakthrough Detection Time in Minutes** | Different Performance for Carmustine and Thiotepa were updated following the Year 5 chemotherapy drug and Fentanyl Citrate permeation testing result. Results showed minor numerical variation, however the results remain consistent with the established risk profile and existing warning or precaution statements. The planned labeling update does not modify existing warnings or  |
|   |  Carmustine (3.3 mg/ml) | 20.0 | Carmustine (3.3 mg/ml) | 23.3  |   |
|   |  Cisplatin (1.0 mg/ml) | > 240 | Cisplatin (1.0 mg/ml) | > 240  |   |
|   |  Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 | Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240  |   |
|   |  Dacarbazine (10.0 mg/ml) | > 240 | Dacarbazine (10.0 mg/ml) | > 240  |   |
|   |  Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 | Doxorubicin Hydrochloride (2.0 mg/ml) | > 240  |   |
|   |  Etoposide (Toposar) (20.0 mg/ml) | > 240 | Etoposide (Toposar) (20.0 mg/ml) | > 240  |   |
|   |  Fluorouracil (50.0 mg/ml) | > 240 | Fluorouracil (50.0 mg/ml) | > 240  |   |
|   |  Methotrexate (25.0 mg/ml) | > 240 | Methotrexate (25.0 mg/ml) | > 240  |   |
|   |  Mitomycin C (0.5 mg/ml) | > 240 | Mitomycin C (0.5 mg/ml) | > 240  |   |
|   |  Paclitaxel (Taxol) (6.0 mg/ml) | > 240 | Paclitaxel (Taxol) (6.0 mg/ml) | > 240  |   |
|   |  Thiotepa (10.0 mg/ml) | 54.0 | Thiotepa (10.0 mg/ml) | 58.2  |   |
|   |  Vincristine Sulfate (1.0 mg/ml) | > 240 | Vincristine Sulfate (1.0 mg/ml) | > 240  |   |
|   |  5-Azacytidine, 25 mg/ml | > 240 | 5-Azacytidine, 25 mg/ml | > 240  |   |
|   |  Carboplatin, 10 mg/ml | > 240 | Carboplatin, 10 mg/ml | > 240  |   |
|   |  Docetaxel, 10 mg/ml | > 240 | Docetaxel, 10 mg/ml | > 240  |   |
|   |  Epirubicin, 2 mg/ml | > 240 | Epirubicin, 2 mg/ml | > 240  |   |
|   |  Gemcitabine, 38 mg/ml | > 240 | Gemcitabine, 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, 2 mg/ml | > 240 | Mitoxantrone, 2 mg/ml | > 240  |   |
|   |  Oncovin, 1.0mg/ml | > 240 | Oncovin, 1.0mg/ml | > 240  |   |
|   |  Oxaliplatin, 5 mg/ml | > 240 | Oxaliplatin, 5 mg/ml | > 240  |   |

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|  Characteristics and Parameters | Subject Device |   | Predicate Device (K200019) |   | Discussion  |
| --- | --- | --- | --- | --- | --- |
|   | Vinorelbine, 10 mg/ml | > 240 | Vinorelbine, 10 mg/ml | > 240 | precautions and does not introduce any new or increased risks to users. The labeling update reflects updated test data only, and the glove continues to perform as intended, maintaining its established functional and safety characteristics.  |
|   |  **Fentanyl Citrate and Concentration** | **Minimum Breakthrough Detection Time in Minutes** | **Fentanyl Citrate and Concentration** | **Minimum Breakthrough Detection Time in Minutes**  |   |
|   |  Fentanyl Citrate Injection (100mcg/2ml) | > 240 | Fentanyl Citrate Injection (100mcg/2ml) | > 240  |   |
|   |  **Blue** Caution: Testing showed an average breakthrough time of 20.0 minutes with Carmustine and 54.0 with Thiotepa Warning: Do not use with Carmustine |   | **Blue** Caution: Testing showed an average breakthrough time of 23.3 minutes with Carmustine and 58.2 with Thiotepa Warning: Do not use with Carmustine  |   |   |
|  Indication for Use | **Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Black)** A non-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. |   | **Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Black)** A non-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 Fentanyl Citrate Performance | **Chemotherapy Drug and Concentration** | **Minimum Breakthrough Detection Time in Minutes** | **Chemotherapy Drug and Concentration** | **Minimum Breakthrough Detection Time in Minutes** | Same  |
|   |  Carmustine (3.3 mg/ml) | 25.0 | Carmustine (3.3 mg/ml) | 25.0  |   |
|   |  Cisplatin (1.0 mg/ml) | > 240 | Cisplatin (1.0 mg/ml) | > 240  |   |
|   |  Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 | Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240  |   |
|   |  Dacarbazine (10.0 mg/ml) | > 240 | Dacarbazine (10.0 mg/ml) | > 240  |   |
|   |  Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 | Doxorubicin Hydrochloride (2.0 mg/ml) | > 240  |   |
|   |  Etoposide (Toposar) (20.0 mg/ml) | > 240 | Etoposide (Toposar) (20.0 mg/ml) | > 240  |   |
|   |  Fluorouracil (50.0 mg/ml) | > 240 | Fluorouracil (50.0 mg/ml) | > 240  |   |
|   |  Methotrexate (25.0 mg/ml) | > 240 | Methotrexate (25.0 mg/ml) | > 240  |   |
|   |  Mitomycin C (0.5 mg/ml) | > 240 | Mitomycin C (0.5 mg/ml) | > 240  |   |
|   |  Paclitaxel (Taxol) (6.0 mg/ml) | > 240 | Paclitaxel (Taxol) (6.0 mg/ml) | > 240  |   |
|   |  Thiotepa (10.0 mg/ml) | 55.7 | Thiotepa (10.0 mg/ml) | 55.7  |   |
|   |  Vincristine Sulfate (1.0 mg/ml) | > 240 | Vincristine Sulfate (1.0 mg/ml) | > 240  |   |
|   |  5-Azacytidine, 25 mg/ml | > 240 | 5-Azacytidine, 25 mg/ml | > 240  |   |
|   |  Carboplatin, 10 mg/ml | > 240 | Carboplatin, 10 mg/ml | > 240  |   |
|   |  Docetaxel, 10 mg/ml | > 240 | Docetaxel, 10 mg/ml | > 240  |   |
|   |  Epirubicin, 2 mg/ml | > 240 | Epirubicin, 2 mg/ml | > 240  |   |
|   |  Gemcitabine, 38 mg/ml | > 240 | Gemcitabine, 38 mg/ml | > 240  |   |

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|  Characteristics and Parameters | Subject Device |   | Predicate Device (K200019) |   | Discussion  |
| --- | --- | --- | --- | --- | --- |
|   | Hosfamide, 50 mg/ml | > 240 | Hosfamide, 50 mg/ml | > 240 |   |
|   |  Irinotecan, 20 mg/ml | > 240 | Irinotecan, 20 mg/ml | > 240  |   |
|   |  Mitoxantrone, 2 mg/ml | > 240 | Mitoxantrone, 2 mg/ml | > 240  |   |
|   |  Oncovin, 1.0mg/ml | > 240 | Oncovin, 1.0mg/ml | > 240  |   |
|   |  Oxaliplatin, 5 mg/ml | > 240 | Oxaliplatin, 5 mg/ml | > 240  |   |
|   |  Vinorelbine, 10 mg/ml | > 240 | Vinorelbine, 10 mg/ml | > 240  |   |
|   |  |   |   |   |   |
|   | **Fentanyl Citrate and Concentration** | **Minimum Breakthrough Detection Time in Minutes** | **Fentanyl Citrate and Concentration** | **Minimum Breakthrough Detection Time in Minutes** |   |
|   |  Fentanyl Citrate Injection (100mcg/2ml) | > 240 | Fentanyl Citrate Injection (100mcg/2ml) | > 240  |   |
|   | **Black** Caution: Testing showed an average breakthrough time of 25.0 minutes with Carmustine and 55.7 with Thiotepa Warning: Do not use with Carmustine |   | **Black** Caution: Testing showed an average breakthrough time of 25.0 minutes with Carmustine and 55.7 with Thiotepa Warning: Do not use with Carmustine |   |   |
|  **Type of use** | Over the counter use |   | Over the counter use |   | Same  |
|  **Materials** | Nitrile |   | Nitrile |   | Same  |
|  **Color** | Blue Black |   | Blue Black |   | Same  |
|  **Design** | • Single Use • Non-Sterile • Powder-Free • Ambidextrous |   | • Single Use • Non-Sterile • Powder-Free • Ambidextrous |   | Same  |
|  **Sterility** | Non-Sterile |   | Non-Sterile |   | Same  |
|  **Freedom from holes** | Meets ASTM D5151-19 (2023): AQL 2.5 |   | Meets ASTM D5151-06(2015): AQL 2.5 |   | Same  |
|  **Length** | Meets ASTM D6319-19 (2023): Overall Length: ≥ 230 mm |   | Meets ASTM D6319-10 (2015): Overall Length: ≥ 230 mm |   | Same  |
|  **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) |   | Same  |
|  **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 |   | Same  |

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|  Characteristics and Parameters | Subject Device | Predicate Device (K200019) | Discussion  |
| --- | --- | --- | --- |
|  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 % | Same  |
|  Powder residual | Meets ASTM D6319-19 (2023) & ASTM D6124-06 (2022): Residual Powder: ≤ 2 mg per glove | Meets ASTM D6319-10 (2015) & ASTM D6124-06 (2017): Residual Powder: ≤ 2 mg per glove | Same  |
|  Primary Skin Irritation ISO 10993-10/ 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 Oral Toxicity Study ISO 10993-11 | Under the conditions of the study, the device does not induce acute systemic toxicity response. | Under the conditions of the study, the device does not induce acute systemic toxicity response. | Same  |
|  Expiration date labelling claim | 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 labeling claim on both blue and black glove variants. Additionally, for blue glove variant 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  |

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|  Characteristics and Parameters | Subject Device | Predicate Device (K200019) | Discussion  |
| --- | --- | --- | --- |
|   |  |  | statements. Real-time aging data support the proposed labeling, and the modification does not affect the safety or effectiveness of the device.  |

## SUMMARY OF NON-CLINICAL TESTING:

The subject devices and the predicate devices share the same intended use, identical material and identical manufacturing, and therefore share the same chemotherapy drug and Fentanyl Citrate permeation testing, biocompatibility characteristics and compliance with ASTM D6319.

The expiration date labeling 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, and ASTM D5151, and demonstrated continued compliance with physical property and barrier integrity requirements through the labeled shelf life.

|  Testing Performed | 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 | - Conform to ASTM D6319 tensile strength of at least minimum 14 MPa and ultimate elongation of at least minimum 500% - Freedom from holes per ASTM D5151 (AQL ≤2.5) | Pass  |
|  *Chemotherapy Drug Permeation and Fentanyl Citrate (ASTM D6978) | 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 | No adverse impact on chemotherapy drug and fentanyl permeation performance was observed following 5 years of real-time aging. The results continue to support the previously cleared labeling claims for the black glove variant. For the blue glove variant, the labeling has been updated to reflect the 5-year real-time aged chemotherapy drug permeation  |

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|  Testing Performed | Purpose | Criteria | Result  |
| --- | --- | --- | --- |
|   |  |  | results. The existing warning statement remains applicable and unchanged, as the updated results do not introduce new risks and continue to ensure end-user safety.  |

*Chemotherapy Drug and Fentanyl Citrate permeation testing in accordance with ASTM D6978 was performed on gloves aged through the full 5-year real-time shelf life.*

The following testing was previously performed on the physically identical predicate device.

|  Test | Purpose | Criteria | Result  |
| --- | --- | --- | --- |
|  Standard Test Method for Detection of Holes in Medical Gloves ASTM D6319-10 (2015) | To demonstrate glove integrity | Freedom from holes AQL 2.5 | Pass  |
|  Standard Test Method for Residual Powder on Medical Gloves ASTM D6124-06 (2017) | To demonstrate the gloves are 'powder free' | Average less than 2 mg/glove | Pass  |
|  Dimensional Conformance ASTM D6319-10 (2015) | 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 D6319-10 (2015) | 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 10993-10 | To demonstrate low potential for skin irritation | Under the conditions of the study, not an irritant. | Pass  |

{16}

|  Test | Purpose | Criteria | Result  |
| --- | --- | --- | --- |
|  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  |
|  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 (Cytoxan) (20 mg/ml) Dacarbazine (10 mg/ml) Doxorubicin Hydrochloride (2 mg/ml) Etoposide (Toposar) (20 mg/ml) Fluorouracil (50 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Paclitaxel (Taxol) (6 mg/ml) Thiotepa (10 mg/ml) Vincristine Sulfate (1 mg/ml) 5-Azacytidine, 25 mg/ml Carboplatin, 10 mg/ml Docetaxel, 10 mg/ml Epirubicin, 2 mg/ml Gemcitabine, 38 mg/ml Ifosfamide, 50 mg/ml Irinotecan, 20 mg/ml Mitoxantrone HCl, 2 mg/ml Oncovin, 1.0mg/ml Oxaliplatin, 5 mg/ml Vinorelbine, 10 mg/ml Fentanyl Citrate Injection, 100 mcg/2mL | N/A | **Carmustine Minimum breakthrough time:** Blue 23.3 minutes Black: 25.0 minutes **Thiotepa Minimum breakthrough time:** Blue: 58.2 minutes Black: 55.7 minutes No breakthrough detected during 240-minute test duration for remaining tested chemotherapy drugs and fentanyl citrate  |

### CLINICAL PERFORMANCE DATA:

Not applicable. There was no clinical data required to support the subject devices as the indication for use is equivalent to the predicate devices.

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# CONCLUSION:

The conclusions drawn from the non-clinical testing demonstrate that the subject device are as safe, as effective, and performs as well as or better than the legally marketed predicate device K200019, Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Blue) and Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Black).

---

**Source:** [https://fda.innolitics.com/device/K260867](https://fda.innolitics.com/device/K260867)

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