Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)

K261793 · Maxter Healthcare, Inc. · LZA · Sep 9, 2026 · General Hospital

Device Facts

• Record ID: K261793
• Device Name: Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)
• Applicant: Maxter Healthcare, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Sep 9, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

The Powder-free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue Color), are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile glove. In addition, these gloves were tested Tested for Use with Chemotherapy Drugs and Fentanyl Citrate in accordance with ASTM D6978-05(Re-approved 2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The Powder-free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black Color), are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile glove. In addition, these gloves were tested Tested for Use with Chemotherapy Drugs and Fentanyl Citrate in accordance with ASTM D6978-05(Re-approved 2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs

Device Story

Single-use, non-sterile, powder-free nitrile rubber latex (NBR) examination gloves; available in blue and black colors. Manufactured via continuous dipping process. Designed to provide a barrier between patient and examiner to prevent contamination. Tested for permeation resistance against chemotherapy drugs and fentanyl citrate per ASTM D6978-05. Used in clinical settings by healthcare examiners. Provides protection against chemical exposure during handling of hazardous drugs. Performance verified through bench testing for physical properties, freedom from holes, and biocompatibility.

Clinical Evidence

No clinical studies were conducted. Substantial equivalence is supported by bench performance testing, including physical properties (tensile strength, elongation), freedom from holes (ASTM D5151), residual powder content, and chemical permeation testing (ASTM D6978). Biocompatibility testing (ISO 10993-5, -10, -11, -23) confirms the device is non-irritant, non-sensitizing, and lacks acute systemic toxicity.

Technological Characteristics

Material: Nitrile Rubber Latex (NBR). Form factor: Examination glove, six sizes (XS-XXL), blue and black. Standards: ASTM D6319-19 (physical properties), ASTM D6978-05 (chemotherapy permeation), ASTM D3767-03 (dimensions), ASTM D5151-19 (holes), ASTM D6124-06 (powder). Non-sterile. Single-use. No software or electronic components.

Indications for Use

Indicated for use as a single-use, non-sterile, powder-free nitrile examination glove worn by examiners to prevent cross-contamination between patient and examiner. Tested for permeation resistance against specific chemotherapy drugs and fentanyl citrate per ASTM D6978-05 (2023). Contraindicated for use with Carmustine and Thiotepa due to low permeation breakthrough times.

Regulatory Classification

Identification

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

Predicate Devices

• Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs (K213040)

Submission Summary (Full Text)

{0}


September 9, 2026

Maxter Healthcare, Inc.
Sajeev Joseph
Senior Director- QA, RA, OSHA
14559 County Rd. 48
Rosharon, Texas 77583

Re: K261793

Trade/Device Name: Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)

Regulation Number: 21 CFR 880.6250

Regulation Name: Non-Powdered Patient Examination Glove

Regulatory Class: Class I, reserved

Product Code: LZA, LZC, OPJ, QDO

Dated: August 10, 2026

Received: August 10, 2026

Dear Sajeev Joseph:

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.

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"

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

{1}

K261793 - Sajeev Joseph

Page 2

(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-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).

{2}

K261793 - Sajeev Joseph

Page 3

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)

K261793

Device Name

Powder-free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue Color)

Indications for Use (Describe)

The Powder-free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue Color), are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile glove. In addition, these gloves were tested Tested for Use with Chemotherapy Drugs and Fentanyl Citrate in accordance with ASTM D6978-05(Re-approved 2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs

| Chemotherapy Drugs | Minimum Breakthrough Detection Time (Minutes) |
| --- | --- |
| Carmustine, 3.3 mg/mL (3,300 ppm) | 20.0 min. |
| Cisplatin, 1 mg/mL (1,000 ppm) | >240 min. |
| Cyclophosphamide, 20 mg/mL (20,000 ppm) | >240 min. |
| Cytarabine HCl, 100 mg/mL (100,000 ppm) | >240 min. |
| Dacarbazine (DTIC), 10 mg/mL (10,000 ppm) | >240 min. |
| Doxorubicin HCl, 2 mg/mL (2,000 ppm) | >240 min. |
| Etoposide, 20 mg/mL (20,000 ppm) | >240 min. |
| Fluorouracil, 50 mg/mL (50,000 ppm) | >240 min. |
| Ifosfamide, 50 mg/mL (50,000 ppm) | >240 min. |
| Methotrexate, 25 mg/mL (25,000 ppm) | >240 min. |
| Mitomycin C, 0.5 mg/mL (500 ppm) | >240 min. |
| Mitoxantrone HCl, 2 mg/mL (2,000 ppm) | >240 min. |
| Paclitaxel, 6 mg/mL (6,000 ppm) | >240 min. |
| Thiotepa, 10 mg/mL (10,000 ppm) | 18.7 min. |
| Vincristine Sulfate, 1 mg/mL (1,000 ppm) | >240 min. |

Fentanyl Citrate Breakthrough Detection Time

Fentanyl Citrate Injection, 100mcg/2 mL >240 min.

Warning: Please note that the following drugs have low permeation time. Carmustine: 20 minutes and Thiotepa: 18.7 minutes. Do not use with Carmustine or Thiotepa

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 1 of 4

PSC Publishing Services [phone]

EF

{4}

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 4

{5}

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)

K261793

Device Name

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

Indications for Use (Describe)

The Powder-free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black Color), are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile glove. In addition, these gloves were tested Tested for Use with Chemotherapy Drugs and Fentanyl Citrate in accordance with ASTM D6978-05(Re-approved 2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs

| Chemotherapy Drugs | Minimum Breakthrough Detection Time (Minutes) |
| --- | --- |
| Carmustine,3.3 mg/mL (3,300 ppm) | 40 min. |
| Cisplatin,1 mg/mL (1,000 ppm) | >240 min. |
| Cyclophosphamide,20 mg/mL (20,000 ppm) | >240 min. |
| Cytarabine HCl,100 mg/mL (100,000 ppm) | >240 min. |
| Dacarbazine (DTIC), 10 mg/mL (10,000 ppm) | >240 min. |
| Doxorubicin HCl,2 mg/mL (2,000 ppm) | >240 min. |
| Etoposide, 20 mg/mL (20,000 ppm) | >240 min. |
| Fluorouracil,50 mg/mL (50,000 ppm) | >240 min. |
| Ifosfamide,50 mg/mL (50,000 ppm) | >240 min. |
| Methotrexate,25 mg/mL (25,000 ppm) | >240 min. |
| Mitomycin C,0.5 mg/mL (500 ppm) | >240 min. |
| Mitoxantrone HCl,2 mg/mL (2,000 ppm) | >240 min. |
| Paclitaxel, 6 mg/mL (6,000 ppm) | >240 min. |
| Thiotepa, 10 mg/mL (10,000 ppm) | 60 min. |
| Vincristine Sulfate,1 mg/mL (1,000 ppm) | >240 min. |

Fentanyl Citrate Breakthrough Detection Time

Fentanyl Citrate Injection, 100mcg/2 mL

>240 min.

Warning: Please note that the following drugs have low permeation time. Carmustine: 40 minutes and Thiotepa: 60 minutes. Do not use with Carmustine or Thiotepa

These gloves were tested for use with Fentanyl Citrate as per ASTM D6978 with a minimum breakthrough detection time of >240 minutes

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

☐

Prescription Use (Part 21 CFR 801 Subpart D)

☑

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

FORM FDA 3881 (8/23)

Page 3 of 4

PSC Publishing Services [phone]

EF

{6}

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 4 of 4

{7}


## 510(k) Summary

**510(k) Number:** K261793

**Date Prepared:** 09/09/2026

**1.0 Submitter Information:** Maxter Healthcare Inc.
14559 County Road 48
Rosharon, Texas 77583, USA

**2.0 Contact Information:** Sajeev Joseph
Senior Director-QA, RA & OSHA
Cell: [phone]
Tel: [phone]
Toll-free: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.maxtergloves.com

**3.0 Correspondent Information:** Sajeev Joseph
Maxter Healthcare Inc.
14559, County Rd 48
Rosharon, Texas 77583
Phone: [phone]
Email: [e-mail]

### 4.0 Device Information

| **Trade Name:** | Powder-free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) |
| --- | --- |
| **Common Name:** | Powder-free Nitrile Patient Examination Gloves |
| **Classification Regulation:** | 21 CFR 880.6250 |
| **Classification Name:** | Powder-free patient examination gloves |
| **Classification Panel:** | General Hospital |

---Page 1 of 14

{8}


**Device Classification:** Class I **Product Code:** LZA, LZC, OPJ, QDO

## 5.0 Predicate Device

**510(k) Number:** K213040

**Trade name:** Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs

**Common name:** Patient Examination Glove

**Classification:** Class I

**Product Code:** LZA, LZC, OPJ, QDO

## 6.0 Description

The proposed device, Powder-free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color), is made from Nitrile Rubber Latex (NBR Latex). The gloves are made by continuous dipping and are stripped and packed into boxes through an automated manufacturing process.

The gloves are offered in six sizes, X-Small, S-Small, M-Medium, L-Large, XL- Extra Large, XXL- Extra Extra Large. The colors included for all the sizes are Blue and Black.

The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with Chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2023).

## 7.0 Indication for Use

### 7.1 For Powder-free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue Color)

The Powder-free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue Color), are intended **to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile glove.** In addition, these gloves were tested Tested for Use with Chemotherapy Drugs and Fentanyl Citrate in accordance with ASTM D6978-05(Reapproved 2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs

---Page 2 of 14

{9}


MAXTER

HEALTHCARE INC

# Chemotherapy Drug Breakthrough Detection Time (Blue Colored Gloves)

| Chemotherapy Drugs | Minimum Breakthrough Detection Time (Minutes) |
| --- | --- |
| Carmustine, 3.3 mg/mL (3,300 ppm) | 20.0 |
| Cisplatin, 1 mg/mL (1,000 ppm) | >240 min. |
| Cyclophosphamide, 20 mg/mL (20,000 ppm) | >240 min. |
| Cytarabine HCl, 100 mg/mL (100,000 ppm) | >240 min. |
| Dacarbazine (DTIC), 10 mg/mL (10,000 ppm) | >240 min. |
| Doxorubicin HCl, 2 mg/mL (2,000 ppm) | >240 min. |
| Etoposide, 20 mg/mL (20,000 ppm) | >240 min. |
| Fluorouracil, 50 mg/mL (50,000 ppm) | >240 min. |
| Ifosfamide, 50 mg/mL (50,000 ppm) | >240 min. |
| Methotrexate, 25 mg/mL (25,000 ppm) | >240 min. |
| Mitomycin C, 0.5 mg/mL (500 ppm) | >240 min. |
| Mitoxantrone HCl, 2 mg/mL (2,000 ppm) | >240 min. |
| Paclitaxel, 6 mg/mL (6,000 ppm) | >240 min. |
| Thiotepa, 10 mg/mL (10,000 ppm) | 18.7 |
| Vincristine Sulfate, 1 mg/mL (1,000 ppm) | >240 min. |

Page 3 of 14

{10}


MAXTER

HEALTHCARE INC

### Fentanyl Citrate Breakthrough Detection Time

Fentanyl Citrate Injection, 100mcg/2 mL >240 min.

Warning: Please note that the following drugs have low permeation time. Carmustine: 20 minutes and Thiotepa: 18.7 minutes. Do not use with Carmustine or Thiotepa

These gloves were tested for use with Fentanyl Citrate as per ASTM D6978 with a minimum breakthrough detection time of >240 minutes

### 7.2 For Powder-free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black Color)

The Powder-free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black Color), are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile glove. In addition, these gloves were tested Tested for Use with Chemotherapy Drugs and Fentanyl Citrate in accordance with ASTM D6978-05(Re-approved 2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs

Chemotherapy Drug Breakthrough Detection Time (Black Colored Gloves)

| Chemotherapy Drugs | Minimum Breakthrough Detection Time (Minutes) |
| --- | --- |
| Carmustine, 3.3 mg/mL (3,300 ppm) | 40.0 |
| Cisplatin, 1 mg/mL (1,000 ppm) | >240 min. |
| Cyclophosphamide, 20 mg/mL (20,000 ppm) | >240 min. |
| Cytarabine HCl, 100 mg/mL (100,000 ppm) | >240 min. |
| Dacarbazine (DTIC), 10 mg/mL (10,000 ppm) | >240 min. |
| Doxorubicin HCl, 2 mg/mL (2,000 ppm) | >240 min. |
| Etoposide, 20 mg/mL (20,000 ppm) | >240 min. |
| Fluorouracil, 50 mg/mL (50,000 ppm) | >240 min. |
| Ifosfamide, 50 mg/mL (50,000 ppm) | >240 min. |

Page 4 of 14

{11}


MAXTER

HEALTHCARE INC

| Methotrexate, 25 mg/mL (25,000 ppm) | >240 min. |
| --- | --- |
| Mitomycin C, 0.5 mg/mL (500 ppm) | >240 min. |
| Mitoxantrone HCl, 2 mg/mL (2,000 ppm) | >240 min. |
| Paclitaxel, 6 mg/mL (6,000 ppm) | >240 min. |
| Thiotepa, 10 mg/mL (10,000 ppm) | 60 |
| Vincristine Sulfate, 1 mg/mL (1,000 ppm) | >240 min. |

### Fentanyl Citrate Breakthrough Detection Time

Fentanyl Citrate Injection, 100mcg/2 mL >240 min.

Warning: Please note that the following drugs have low permeation time. Carmustine: 40 minutes and Thiotepa: 60 minutes. Do not use with Carmustine or Thiotepa

These gloves were tested for use with Fentanyl Citrate as per ASTM D6978 with a minimum breakthrough detection time of >240 minutes

### 8.0 Comparison to Predicate Device

A technological comparison of the proposed device Powder-free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) with the predicate device under 510(k) K213040 is outlined in Table 1.

| Table 1a: Comparison of Nitrile Patient Examination Gloves tested for use with Chemotherapy Drugs & Fentanyl Citrate | | | |
| --- | --- | --- | --- |
| Item | Proposed Device | Predicate (K213040) | Conclusion |
| Product Name | Powder-free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) | Nitrile Patient Examination Gloves Blue Colored Tested For Use With Chemotherapy Drugs. Nitrile Patient Examination Gloves Blue Violet Colored Tested For Use With Chemotherapy Drugs. | Same |

Page 5 of 14

{12}

**MAXTER**^{}[] HEALTHCARE INC

| | | Nitrile Patient Examination Gloves Black Colored Tested For Use with with Fentanyl Citrate. | |
| --- | --- | --- | --- |
| **Product Code** | LZA, LZC, OPJ, QDO | LZA, LZC, OPJ, QDO | Same |
| **Regulation No.** | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| **Class** | I | I | Same |
| **Indication For Use** | Powder-free Nitrile examination glove is intended to be worn on the hands of examiners to prevent contamination between patients and the examiner. This is a single-use, powder-free, non-sterile device. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Re-approved 2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | The nitrile examination glove is intended to be worn on the hands of examiners to prevent contamination between the patient and the examiner. This is a single-use, Powder-free, non-sterile device. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Re-approved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | Same |
| **Main Material** | Nitrile Rubber | Nitrile Rubber | Same |
| **Color** | Blue Black | Blue Blue Violet Black | Similar |
| **Size** | XS-Extra Small S-Small M-Medium L-Large XL- Extra Large XXL-Extra Extra Large | XS-Extra Small S-Small M-Medium L-Large X-Extra Large XXL-Extra Large | Same |
| **Dimensions: Length** | **Complies with:** ASTM D6319-19 XS 230mm min S 230mm min M 230mm min L 230mm min | **Complies with:** ASTM D6319-19 XS 220mm min S 220mm min M 230mm min L 230mm min | Similar |

Page 6 of 14

{13}

MAXTER HEALTHCARE INC

| | XL 230mm min XXL 230mm min | XL 230mm min XXL 230mm min | |
| --- | --- | --- | --- |
| **Dimensions:** **Width** | **Complies with:** ASTM D6319-19 XS 70±10mm S 80±10mm M 95±10mm L 110±10mm XL 120±10mm XXL ≥120mm | **Complies with:** ASTM D6319-19 XS 70±10mm S 80±10mm M 95±10mm L 110±10mm XL 120±10mm XXL ≥120mm | Same |
| **Dimensions:** **Thickness** | **Complies with:** ASTM D6319-19 **Palm:** 0.05mm min **Finger:** 0.10mm min | **Complies with:** ASTM D6319-19 **Palm:** 0.05mm min **Finger:** 0.11mm min | Similar |
| **Physical Properties** | **Complies with:** ASTM D6319-19 **Minimum Tensile Strength:** **Before Aging** ≥14 MPa, min **After Aging** ≥14 MPa, min | **Complies with:** ASTM D6319-19 **Minimum Tensile Strength:** **Before Aging** ≥14 MPa, min **After Aging** ≥14 MPa, min | Same |
| | **Elongation:** **Before Aging** 500%, min **After Aging** 400%, min | **Elongation:** **Before Aging** 500%, min **After Aging** 400%, min | Same |
| **Residual Powder** | **Follows:** ASTM D6319-19 <2 mg/glove | **Complies with:** ASTM D6319-19 <2 mg/glove | Same |
| **Freedom from Holes** | **Complies with:** ASTM D6319-19 Not exceeding 2.5 AQL | **Complies with:** ASTM D6319-19 Not exceeding 2.5 AQL | Same |
| **Contact Duration** | Limited <24 hours | Limited <24 hours | Same |
| **R_{x} Only or OTC** | OTC | OTC | Same |
| **Sterility** | Non-sterile | Non-sterile | Same |
| **Indications for Use** | | | |

Page 7 of 14

{14}


MAXTER

HEALTHCARE INC

| Item | Proposed device | Predicate device (K213040) | Discussion |
| --- | --- | --- | --- |
| Indication for Use | Powder-free Nitrile examination glove is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | Same |
| Biocompatibility | ISO 10993-5 At the neat extraction, the test article is considered cytotoxic. But with the progressive dilutions, the extraction is non-cytotoxic ISO 10993-10: Not a skin irritant ISO 10993-11 No acute systemic toxicity ISO 10993-23 No intracutaneous irritation The acute systemic toxicity, intracutaneous reactivity test and skin sensitization study results demonstrate that the device does not cause systemic toxicity and is non-irritant. | ISO 10993-10: Not a skin irritant Not a skin sensitizer. At the neat extraction, the test article is considered cytotoxic, but the acute systemic toxicity results demonstrate that the device will not cause a systemic effect. | Same |
| Labelling | Complied with: 21 CFR part 801 | Complied with: 21 CFR part 801 | Same |
| Chemotherapy Drugs (for Blue colored gloves) | Nitrile Patient Examination Gloves Tested For Use With | Nitrile Patient Examination Gloves Blue Violet Colored Tested For Use With | Similar |

Page 8 of 14

{15}

MAXTER HEALTHCARE INC

| | Chemotherapy Drugs and Fentanyl Citrate (Blue Color) | Chemotherapy Drugs Nitrile Patient Examination Gloves Black Colored Tested with Fentanyl Citrate | |
| --- | --- | --- | --- |
| | NA | Bleomycin Sulfate 15 mg/ml >240 min. | Similar |
| | Carmustine, 3.3 mg/ml 20 min | Carmustine (BCNU) 3.3 mg/ml 17.2 min. | |
| | Cisplatin 1.0 mg/ml >240 min. | Cisplatin 1.0 mg/ml >240 min. | |
| | Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. | Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. | |
| | Cytarabine HCl 100 mg/ml >240 min. | Cytarabine HCl 100 mg/ml >240 min. | |
| | Dacarbazine (DTIC)10.0 mg/ml >240 min. | Dacarbazine (DTIC)10.0 mg/ml >240 min. | |
| | NA | Daunorubicin 5.0 mg/ml >240 min. | |
| | NA | Docetaxel 10.0 mg/ml >240 min | |
| | Doxorubicin HCl 2.0 mg/ml >240 min. | Doxorubicin HCl 2.0 mg/ml >240 min. | |
| | Etoposide (Toposar) 20.0 mg/ml >240 min. | Etoposide (Toposar) 20.0 mg/ml >240 min. | |
| | Fluorouracil 50.0 mg/ml >240 min | Fluorouracil 50.0 mg/ml >240 min. | |
| | NA | Gemcitabine 38 mg/ml>240 min. | |
| | NA | Idarubicin 1 mg/ml >240 min. | |
| | Ifosfamide 50.0 mg/ml >240 min. | Ifosfamide 50.0 mg/ml >240 min. | |
| | NA | Irinotecan 20.0 mg/ml >240 min. | |
| | NA | Mechlorethamine HCl 1.0 mg/ml>240 min. | |
| | NA | Melphalan 5 mg/ml >240 min. | |
| | Methotrexate 25 mg/ml >240 min. | Methotrexate 25 mg/ml >240 min. | |

Page 9 of 14

{16}


MAXTER

HEALTHCARE INC

| | Mitomycin C. 0.5 mg/ml >240 | Mitomycin C. 0.5 mg/ml >240 | |
| --- | --- | --- | --- |
| | Mitoxantrone 2.0 mg/ml >240 min. | Mitoxantrone 2.0 mg/ml >240 min. | |
| | Paclitaxel (Taxol) 6.0 mg/ml >240 min. | Paclitaxel (Taxol) 6.0 mg/ml >240 min. | |
| | Thiotepa 10.0 mg/ml 18.7 min. | Thiotepa 10.0 mg/ml 13.9 min. | |
| | Vincristine Sulfate, 1 mg/ml (1,000 ppm)>240 min | Vincristine Sulfate 1.0 mg/ml >240 min. | |
| Fentanyl Citrate | Fentanyl Citrate 100mcg/2ml >240 minutes | Fentanyl Citrate 100mcg/2ml >240 minutes | Same |
| Chemotherapy Drugs (for Black Colored Gloves) | Nitrile Patient Examination Gloves Black Colored Tested For Use With Chemotherapy Drugs and Fentanyl Citrate | Nitrile Patient Examination Gloves Blue Violet Colored Tested For Use With Chemotherapy Drugs Nitrile Patient Examination Gloves Black Colored Tested with Fentanyl Citrate | Similar |
| | NA | Bleomycin Sulfate 15 mg/ml >240 min. | Similar |
| | Carmustine, 3.3 mg/ml 40 min | Carmustine (BCNU) 3.3 mg/ml 17.2 min. | |
| | Cisplatin 1.0 mg/ml >240 min. | Cisplatin 1.0 mg/ml >240 min. | |
| | Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. | Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min. | |
| | Cytarabine HCl 100 mg/ml >240 min. | Cytarabine HCl 100 mg/ml >240 min. | |
| | Dacarbazine (DTIC)10.0 mg/ml >240 min. | Dacarbazine (DTIC)10.0 mg/ml >240 min. | |
| | NA | Daunorubicin 5.0 mg/ml >240 min. | |
| | NA | Docetaxel 10.0 mg/ml >240 min | |
| | Doxorubicin HCl 2.0 mg/ml >240 min. | Doxorubicin HCl 2.0 mg/ml >240 min. | |
| | Etoposide (Toposar) 20.0 mg/ml >240 min. | Etoposide (Toposar) 20.0 mg/ml >240 min. | |

Page 10 of 14

{17}

**MAXTER**^{}[] HEALTHCARE INC

| | Fluorouracil 50.0 mg/ml >240 min | Fluorouracil 50.0 mg/ml >240 min. | |
| --- | --- | --- | --- |
| | NA | Gemcitabine 38 mg/ml >240 min. | |
| | NA | Idarubicin 1 mg/ml >240 min. | |
| | Ifosfamide 50.0 mg/ml >240 min. | Ifosfamide 50.0 mg/ml >240 min. | |
| | NA | Irinotecan 20.0 mg/ml >240 min. | |
| | NA | Mechlorethamine HCl 1.0 mg/ml >240 min. | |
| | NA | Melphalan 5 mg/ml >240 min. | |
| | Methotrexate 25 mg/ml >240 min. | Methotrexate 25 mg/ml >240 min. | |
| | Mitomycin C. 0.5 mg/ml >240 | Mitomycin C. 0.5 mg/ml >240 | |
| | Mitoxantrone 2.0 mg/ml >240 min. | Mitoxantrone 2.0 mg/ml >240 min. | |
| | Paclitaxel (Taxol) 6.0 mg/ml >240 min. | Paclitaxel (Taxol) 6.0 mg/ml >240 min. | |
| | Thiotepa 10.0 mg/ml 60 min. | Thiotepa 10.0 mg/ml 13.9 min. | |
| | Vincristine Sulfate, 1 mg/ml (1,000 ppm) >240 min | Vincristine Sulfate 1.0 mg/ml >240 min. | |
| | Fentanyl Citrate 100mcg/2ml >240 minutes | Fentanyl Citrate 100mcg/2ml >240 minutes | Same |
| **Shelf Life of the Gloves** | Max 3 years from manufacturing date | Information is not available | Not applicable |

**Table 2b: Discussion on Particulars Where the Proposed and the Predicate device Properties are Similar and not the Same**

| Particulars | Results for the Proposed Device | Results for the Predicate (K213040) | Rationale why the difference does not affect the safety and efficacy of the proposed device |
| --- | --- | --- | --- |
| **Color** | The color stated in the submission are Blue Black | Blue Blue Violet Black | Blue violet is an additional color in K213040 and the proposed device covers only blue and black |

Page 11 of 14

{18}

**MAXTER**^{}[] HEALTHCARE INC

| **Dimensions: Length** | The minimum length for size XS and S is 230 mm | The minimum length for size XS and S is 220 mm | Both the proposed and predicate device meets the requirements of ASTM D 6319 |
| --- | --- | --- | --- |
| **Dimensions: Thickness** | Finger thickness is min 0.10mm | Finger thickness is min 0.11mm | The difference is marginal and both the devices meet the requirements of ASTM D 6319 (0.05 mm minimum) |
| **Chemotherapy Drugs Break Through Time (BTT)** | Tested for 15 chemotherapy drugs | Tested for 23 Chemotherapy drugs | For the tested chemotherapy drugs for the proposed device, the BTT is same for proposed and predicate device |
| **Shelf Life of Gloves** | 3 years from the date of manufacturing | Information is not available from 510k summary | 3-year shelf life is proposed based on the accelerated aging stability studies following ASTM D 7160 guidelines. This will be amended based on the real time stability studies. |

## 9.0 Technological Characteristic Discussion

The proposed device has the same intended use, operating principle, and fundamental scientific technology as the predicate device. Differences between the proposed device and the predicate are limited to color options, certain dimensional specifications, updated ASTM references, and chemotherapy permeation test results. These differences do not alter the mechanism of action, patient-contacting materials, intended use, or performance characteristics and therefore do not raise new questions of safety or effectiveness.

## 10.0 Clinical Testing

No clinical studies were conducted.

## 11.0 Non-Clinical Testing

### 11.1 Bench Performance Testing

| Items | Standard | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Palm width | ASTM D3767-03(2020) | XS (70±10mm) S (80±10mm) M (95±10mm) | Pass |

Page 12 of 14

{19}


MAXTER

HEALTHCARE INC

| | | L (110±10mm) XL (120±10mm) XXL (≥120mm) | |
| --- | --- | --- | --- |
| Length | ASTM D3767-03(2020) | XS (220mm min) S (220mm min) M (230mm min) L (230mm min) XL (230mm min) XXL (230mm min) | Pass |
| Thickness | ASTM D3767-03(2020) | Finger: min 0.10mm Palm: min 0.05mm | Pass |
| Freedom from holes | ASTM D5151-19 | Freedom from hole AQL 2.5 | Pass |
| Physical Properties (before aging) | | | |
| Tensile Strength | ASTM D412-16 | ≥14MPa | Pass |
| Ultimate Elongation | ASTM D412-16 | ≥500% | Pass |
| Physical Properties (after aging) | | | |
| Tensile Strength | ASTM D412-16 | ≥14MPa | Pass |
| Ultimate Elongation | ASTM D412-16 | ≥400% | Pass |
| Residual Powder Content | ASTM D6124-06(2017) | ≤2mg per glove | Pass |
| Chemical Permeation Testing, Chemotherapy drugs and Fentanyl Citrate | ASTM D6978-05(2023) | Report the BTT (Breakthrough Time) for the drugs/chemicals tested | >240 minutes for all drugs tested except for Carmustine and Thiotepa |

### 11.2 Biocompatibility Testing

| Items | Standard | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Cytotoxicity | ISO 10993-5 | Cytotoxic at neat and non-cytotoxic from 1:32 dilutions for Blue colored gloves Cytotoxic at neat and non-cytotoxic from 1:8 dilutions for Black colored gloves | Under conditions of the study, the extract from the device at neat is cytotoxic |
| Acute Systemic | ISO 10993-11 | Non-acute systemic | Under |

Page 13 of 14

{20}


| Toxicity | | Toxicity for blue and black colored gloves | conditions of the study, did not show acute systemic toxicity |
| --- | --- | --- | --- |
| Intracutaneous Reactivity | ISO 10993-23:2021 | Non- Irritant for blue and black colored gloves | Under the conditions of the study the gloves were found non-irritant |
| Skin Sensitization | ISO 10993-10:2021 | Non-Sensitizer for blue and black colored gloves | Under the conditions of the study the gloves were found to be not creating skin sensitization |

## 12.0 Shelf- Life Comparison

Shelf-life information for the predicate device is not publicly available in the FDA 510(k) database. The proposed device includes a shelf life supported by accelerated aging studies conducted in accordance with applicable consensus standards and will be validated with real time studies. The inclusion of shelf-life data for the proposed device does not affect the intended use, technological characteristics, or performance of the device relative to the predicate. Rather, it demonstrates that the proposed device maintains its safety and performance throughout the labeled shelf-life period and therefore does not impact the determination of substantial equivalence.

## 13.0 Conclusion

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

Page 14 of 14