Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a disposable examination glove, and the description focuses on its physical properties and resistance to chemicals, with no mention of AI or ML.

Therapeutic

No
The device is a disposable exam glove intended to prevent contamination between patient and examiner, not to provide therapy or treatment.

Diagnostic

No

The device is described as an "exam glove" whose purpose is "worn on the examiner's hand to prevent contamination between patient and examiner." Its intended use is not to diagnose any condition or disease.

SaMD (Software as a Medical Device)

No

The device is a physical glove, not software. The description clearly outlines its material, physical characteristics, and intended use as a barrier worn on the hand.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for personal protection and infection control.
IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description: The device description confirms it is a "disposable... nitrile... powder-free... patient examination glove." This aligns with the intended use as a barrier device.
Performance Studies: The performance studies focus on the physical properties of the glove (dimensions, pinholes, etc.) and its resistance to permeation by certain drugs. These are relevant to its function as a protective barrier, not to the analysis of biological samples.

The testing for chemotherapy drugs and hazardous drugs is to demonstrate the glove's ability to protect the wearer from exposure to these substances, which is a function of a protective barrier, not an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs. Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: 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 Ifosfamide, 50 mg/ml Mitoxantrone HCl, 2 mg/ml Paclitaxel, 6 mg/ml Vincristine Sulfate, 1 mg/ml

CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 60 minutes: Carmustine, 3.3 mg/ml: No breakthrough up to 35.1 minutes.

CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 120 minutes: Thiotepa. 10 mg/ml: No breakthrough up to 107.2 minutes.

Warning: Not for use with Carmustine, Thiotepa

The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
Fentanyl Citrate Injection (50 mcg/5 ml)
Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

Product codes (comma separated list FDA assigned to the subject device)

LZA, LZC, OPJ, QDO

Device Description

The subject device is a disposable, 9.5" black-colored, chlorinated, nitrile, powder-free, textured, ambidextrous, non-sterile patient examination glove that is packed in a cardboard dispenser box.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiner (medical purposes)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing was conducted including Biocompatibility Testing according to ISO 10993-1:2018 (Surface Device, duration of contact A-Limited (≤24h)), specifically:

ISO 10993-23: Primary Skin Irritation (Results: No dermal irritation reactions - PASS)
ISO 10993-10: Dermal Sensitization (Results: Not a sensitizer - PASS)
ISO 10993-11: Systemic Toxicity (Results: Device extract does not induce acute systemic toxicity response - PASS)

Performance testing was conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and ASTM D6978-05 (2023) Standard Practice for Assessment of resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Tests conducted included:

Dimensions (Length, Palm Width Size, Finger thickness, Palm thickness, Cuff thickness) per ASTM D6319 (Results: PASS)
Physical Properties (Tensile Strength, Ultimate elongation before and after aging) per ASTM D6319 (Results: PASS)
Freedom from Pinholes per ASTM D6319, ASTM D5151 (Results: No leakage - PASS)
Residual Powder per ASTM D6124, ASTM D6319 (Results: ≤ 2 mg/glove - PASS)
Permeation by Chemotherapy Drugs per ASTM D6978 (Results: Refer to indicated table for specific drug breakthrough times - PASS)

Key results for chemotherapy drug permeation:

NO breakthrough detected up to 240 minutes for: 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), Ifosfamide (50 mg/ml), Mitoxantrone HCl (2 mg/ml), Paclitaxel (6 mg/ml), Vincristine Sulfate (1 mg/ml).
Breakthrough detected in less than 60 minutes for: Carmustine (3.3 mg/ml): No breakthrough up to 35.1 minutes.
Breakthrough detected in less than 120 minutes for: Thiotepa (10 mg/ml): No breakthrough up to 107.2 minutes.
NO breakthrough detected up to 240 minutes for Fentanyl Citrate Injection (50 mcg/5 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution.

No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not applicable for this type of device. Performance assessed by physical properties and permeation resistance.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K220373

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K213929, K200633

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Summary

0

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

December 17, 2024

O&M Halyard, Inc. Caitlin Senter Director. Global Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116

Re: K242558

Trade/Device Name: Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: November 18, 2024 Received: November 18, 2024

Dear Caitlin Senter:

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.

1

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

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

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

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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

2

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,

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

Indications for Use

510(k) Number (if known) K242558

Device Name

Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid

Indications for Use (Describe)

Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs. Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: 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 lfosfamide, 50 mg/ml Mitoxantrone HCl, 2 mg/ml Paclitaxel, 6 mg/ml Vincristine Sulfate, 1 mg/ml

CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 60 minutes: Carmustine, 3.3 mg/ml: No breakthrough up to 35.1 minutes.

CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 120 minutes: Thiotepa. 10 mg/ml: No breakthrough up to 107.2 minutes.

Warning: Not for use with Carmustine, Thiotepa

The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:

Fentanyl Citrate Injection (50 mcg/5 ml)
Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 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."

5

Image /page/5/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through them. To the right of the letters is the company name "Owens & Minor" in a light gray color.

510(k) Summary for K242558

This summary of 510(k) K242558 is being submitted in accordance with 21 CFR 807.92.

1. Date Summary was Prepared	December 13, 2024
2. 510(k) Submitter	O & M Halyard, Inc.
9120 Lockwood Blvd.
Mechanicsville, Virginia 23116
3. Primary Contact for this 510(k) Submission	Caitlin Senter, MS, RAC
Tel: 678-221-7330
Email: caitlin.senter@owens-minor.com
4. Marketed Common Name	Nitrile Powder-Free Exam Gloves
5. Device Submission Trade name and Description	Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
6. Device Common Name	Medical Exam Gloves
7. Device Product Code and Classification Name	LZA Class I, 21 CFR §880.6250 Patient Examination Glove
LZC Class I, 21 CFR §880.6250 Patient Examination Glove, Specialty;
OPJ Class I, 21 CFR §880.6250 Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
QDO Class I, 21 CFR §880.6250 Fentanyl and other opioid protection glove
8. Predicate Device	Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves (K220373)
9. Reference Devices	Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K213929)

Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove (K200633) |
| 11. Subject Device Description | The subject device is a disposable, 9.5" black-colored, chlorinated, nitrile,
powder-free, textured, ambidextrous, non-sterile patient examination glove
that is packed in a cardboard dispenser box. |
| | The devices follow consensus standards: |
| | ASTM D5151-06 Standard Test Method for Detection of Holes in Medical
Gloves |
| | ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for
Medical Applications |
| | ASTM D6124-06 Standard Test Method for Residual Powder on Medical
Gloves |
| | ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical
Gloves to Permeation by Chemotherapy Drugs |
| | ISO 10993-11: 2017 Biological evaluation of medical devices – Tests for
systemic toxicity |
| | ISO 10993-10: 2021 Biological evaluation of medical devices -Part 10: Tests
for skin sensitization |
| | ISO 10993-23: 2021 Biological evaluation of medical devices -Part 23: Tests
for irritation |

6

Image /page/6/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the letters. To the right of the letters, the words "Owens & Minor" are written in a gray color. The font used for the words is a serif font.

7

Image /page/7/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the name "Owens & Minor" in gray.

| 12. Indications for Use for
Halyard Black Nitrile Powder-
Free Exam Gloves with Textured
Grip Technology, Tested for Use
with Chemotherapy Drugs,
Fentanyl Citrate, Simulated
Gastric Acid and Fentanyl in
Simulated Gastric Acid | Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip
Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate,
Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable
devices intended for medical purposes that is worn on the examiner's hand to
prevent contamination between patient and examiner. |

--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:

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
Ifosfamide	50 mg/ml
Mitoxantrone HCl	2 mg/ml
Paclitaxel	6 mg/ml
Vincristine Sulfate	1 mg/ml

CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 60 minutes:

Carmustine	3.3 mg/ml: Do not use
------------	-----------------------

CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 120 minutes:

Thiotepa	10 mg/ml: Do not use
----------	----------------------

Warning: Not for use with Carmustine, Thiotepa

The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:

Fentanyl Citrate Injection	(50 mcg/5 ml) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
----------------------------	------------------------------------------------------------------------------------------

8

Image /page/8/Picture/0 description: The image is a logo for Owens & Minor. The logo consists of two parts: a maroon-colored symbol on the left and the company name "Owens & Minor" in gray on the right. The symbol on the left appears to be a stylized representation of the letters "OM" with horizontal lines running through it.

| 13. | Subject Device
Halyard Black
Nitrile Powder-Free
Exam Gloves with
Textured Grip | Predicate Device
K220373 | Reference Device
K213929 | Reference Device
K200633 | Comparison |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| FDA Product
Code | LZA, LZC, OPJ, QDO | LZA, OPJ, QDO | LZA, OPJ, QDO | LZA, QDO, LZC | Similar |
| FDA
Classification | Class I | Class I | Class I | Class I | Same |
| Regulation
Number | 880.6250 | 880.6250 | 880.6250 | 880.6250 | Same |
| Common Name | Non-Powdered
Patient Examination
Glove | Non-Powdered
Patient
Examination Glove | Non-Powdered
Patient
Examination Glove | Non-Powdered
Patient
Examination Glove | Same |
| Device Trade
Name | Halyard Black Nitrile
Powder-Free Exam
Gloves with
Textured Grip
Technology, Tested
for Use with
Chemotherapy
Drugs, Fentanyl
Citrate, Simulated
Gastric Acid and
Fentanyl in
Simulated Gastric
Acid | Get-A-
Grip/Rescue-Grip,
Nitrile Two Toned
Black/Green,
Diamond Grip
Technology,
Powder-Free, Non-
sterile,
Ambidextrous,
Beaded Cuff,
Medical Grade
Exam Gloves | Halyard Purple
Nitrile, Powder-
Free Exam Gloves | Halyard Black-Fire
Powder-Free
Nitrile Exam Glove | Similar |
| Intended Use | The device is a
disposable device
intended for
medical purposes
that is worn on the
examiner's hand to
prevent
contamination
between patient
and examiner.
These gloves were
tested for use with
chemotherapy
drugs, fentanyl
citrate, simulated
gastric acid and
fentanyl in
simulated gastric
acid as listed on the
label. | A Nitrile powder
free exam glove is
a disposable
device, worn on
the hand or finger
to prevent
contamination
between examiner
and patient or
victim.
This specialty
glove has also
been tested for
use with the
Opioid drugs
Fentanyl citrate,
Heroin, and both
Opioids in
simulated Gastric
Acid as listed on
the label. | The devices are
disposable devices
intended for
medical purposes
that is worn on
the examiner's
hand to prevent
contamination
between patient
and examiner.
These gloves were
tested for use
with
chemotherapy
drugs, fentanyl
citrate, simulated
gastric acid
fluid/fentanyl
citrate injection
mix 50/50
Solution as listed
on the label. | The devices are
disposable devices
intended for
medical purposes
that is worn on
the examiner's
hand to prevent
contamination
between patient
and examiner.
These gloves were
tested for use
with fentanyl
citrate as listed on
the label. | Similar |
| Technological
Characteristics | Colored, 9.5 inch,
chlorinated, nitrile,
powder-free,
textured,
ambidextrous, non-
sterile patient
examination glove | Colored, 9.5 inch,
chlorinated, nitrile,
powder-free,
textured,
ambidextrous,
non-sterile patient
examination glove | Colored, 9.5 inch,
chlorinated,
nitrile, powder-
free, textured
fingertip,
ambidextrous,
non-sterile patient
examination glove | Colored, 9.5 inch,
chlorinated,
nitrile, powder-
free, textured
fingertip,
ambidextrous,
non-sterile patient
examination glove | Similar |
| Sizes of gloves | XS, S, M, L, XL, XXL | XS, S, M, L, XL, XXL | XS, S, M, L, XL | XS, S, M, L, XL | Similar |
| Glove Length | 9.5 inch | 9.5 inch | 12 inch | 9.5 inch | Similar |
| Texture | Textured on dorsal
and palmar sides
through the
fingertips | Textured on dorsal
and palmar sides
through the
fingertips | Textured
fingertips | Textured
fingertips | Similar |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same |

9

Image /page/9/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a stylized, maroon-colored font, with horizontal lines running through the letters. To the right of the letters is the company name "Owens & Minor" in a gray, sans-serif font. The logo is clean and professional, and the colors are muted and sophisticated.

| 14. Standard | Subject Device
Halyard Black
Nitrile Powder-
Free Exam Gloves
with Textured Grip | Predicate Device K220373 | Reference Device
K213929 | Reference
Device
K200633 | Comparison | | | | | | | | | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--------------------------------|------------|--|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------|
| ASTM D6978-05
Standard
Practice for
Assessment of
Resistance of
Medical Gloves
to Permeation
by
Chemotherapy
Drugs | The following
chemotherapy
drugs and
concentration had
NO breakthrough
detected up to 240
minutes:
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
Ifosfamide, 50
mg/ml
Mitoxantrone HCl,
2 mg/ml
Paclitaxel, 6 mg/ml
Vincristine Sulfate,
1 mg/ml
CAUTION: The | This specialty glove has also
been tested for use with the
Opioid drugs Fentanyl citrate,
Heroin, and both Opioids in
simulated Gastric Acid.
Test Opioid Drug Concentration Minimum
Breakthrough Time Fentanyl citrate (injectable) (100mcg/2ml) >240 minutes Fentanyl citrate (injectable)

Heroin (100mcg/2ml)
+(saturated solution) >240 minutes Fentanyl citrate (injectable)
Heroin in Simulated Gastric
Acid Mix 100mcg/2ml
Saturated Solution into
simulated Gastric Acid >240 minutes | | | | | | | | | | | | | The following
chemotherapy
drugs and
concentration had
NO breakthrough
detected up to
240 minutes:
Azacitidine (25
mg/ml)
Bendamustine HCl
(5 mg/ml)
Bleomycin Sulfate
(15 mg/ml)
Bortezomib (1
mg/ml)
Busulfan (6
mg/ml)
Capecitabine (26
mg/ml)
Carboplatin (10
mg/ml) Carfilzomib
(2 mg/ml)
Cetuximab (2
mg/ml)
Chloroquine (50
mg/ml)
Cisplatin (1 | The following
drugs
showed not
breakthrough
at 240
minutes:
Fentanyl
Citrate, 100
mcg/2ml | Similar |

10

Image /page/10/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a bold, maroon font on the left side of the image. To the right of the letters is the company name "Owens & Minor" in a gray, serif font.

| following
chemotherapy
drug and
concentration
showed
breakthrough
detected in less
than 60 minutes:
Carmustine, 3.3
mg/ml: Do not use | mg/ml) Cladribine
(1 mg/ml)
Cyclophosphamide
(20 mg/ml)
Cyclosporin A (100
mg/ml)
Cytarabine
(Cytosine) (100
mg/ml) Cytovene
(Ganciclovir) (10
mg/ml)
Dacarbazine
(DTIC) (10 mg/ml)
Dactinomycin (0.5
mg/ml)
Daunorubicin HCl
(5 mg/ml)
Decitabine (5
mg/ml)
Docetaxel (10
mg/ml)
Doxorubicin HCl (2
mg/ml)
Epirubicin HCl
(Ellence) (2
mg/ml) Etoposide
(Toposar) (20
mg/ml)
Fludarabine (25
mg/ml) 5-
Fluorouracil (50
mg/ml)
Fulvestrant (50
mg/ml)
Gemcitabine (38
mg/ml)
Idarubicin (1
mg/ml) Ifosfamide
(50 mg/ml)
Irinotecan HCl (20
mg/ml) Leuprolide
Acetate Salt (5
mg/ml)
Mechlorethamine
HCl (1 mg/ml)
Melphalan (5
mg/ml)
Methotrexate (25
mg/ml) Mitomycin
C (0.5 mg/ml)
Mitoxantrone (2
mg/ml) Oxaliplatin
(5 mg/ml)
Paclitaxel (6
mg/ml)
Pemetrexed (25
mg/ml) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CAUTION: The
following
chemotherapy
drug and
concentration
showed
breakthrough
detected in less
than 120 minutes:
Thiotepa, 10
mg/ml: Do not use | |
| Warning: Not for
use with
Carmustine,
Thiotepa | |
| The following
hazardous drugs
(opioids) and
concentration had
NO breakthrough
detected up to 240
minutes:
Fentanyl Citrate
Injection (50 mcg/5
ml) Simulated
Gastric Acid
Fluid/Fentanyl
Citrate Injection
Mix 50/50 Solution | |

11

Image /page/11/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the "O". To the right of the letters is the company name "Owens & Minor" in a gray color. The font is sans-serif and the overall design is clean and professional.

| Biocompatibility
Sensitization

ISO 10993-10
	Under the
conditions of the
study, not a
sensitizer.	Under the conditions of the
study, not a sensitizer. Under
the conditions of the study,
not an irritant.	Raltitrexed (0.5 mg/ml) Retrovir
(10 mg/ml)
Rituximab (10 mg/ml)
Temsirolimus (25 mg/ml)
Topotecan HCl (1 mg/ml) Triclosan
(2 mg/ml)
Trisenox (1 mg/ml)
Vinblastine Sulfate
(1 mg/ml)
Vincristine (1 mg/ml)
Vinorelbine (10 mg/ml)
Zoledronic Acid
(0.8 mg/ml)
The following
chemotherapy
drugs and
concentration
showed
breakthrough
detected in less
than 90 minutes:
Carmustine (3.3
mg/ml) No
breakthrough up
to 55.3 minutes.
Thiotepa (10
mg/ml) No
breakthrough up
to 78.8 minutes.
Warning- Not for
use with
Carmustine and
ThioTEPA
No breakthrough
was detected up
to 240 minutes for
Fentanyl Citrate
Injection (100
mcg/2 ml) and
Simulated Gastric
Acid
Fluid/Fentanyl
Citrate Injection
Mix 50/50
Solution	Under the
conditions of the
study, not a
sensitizer. Under
the conditions of
the study	Under the
conditions of
the study,
not a
sensitizer.
Under the	Same
			irritant.	conditions of
the study,
not an
irritant.
Biocompatibility
Cytotoxicity
ISO 10993-5	Not Performed	Under the conditions of this
study, the test article extract
showed potential toxicity to
L929 cells. Cytotoxicity
concern was addressed by
acute systematic toxicity
testing.	Not Performed	Not
Performed	Different
from
K220373
Same as
K200633
and
K213929
Biocompatibility
Acute Systemic
Toxicity
ISO 10993-11	Under the
conditions of the
study, the device
extract does not
induce acute
systemic toxicity
response.	Under the conditions of this
study, there was no evidence
of acute systemic toxicity.	Under the
conditions of this
study, there was
no evidence of
acute systemic
toxicity.	Under the
conditions of
this study,
there was no
evidence of
acute
systemic
toxicity.	Same
Biocompatibility
Irritation
ISO 10993-23	Under the
conditions of the
study, not an
irritant.	Not Performed	Not Performed	Not
Performed	Different

12

Image /page/12/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the name "Owens & Minor" in a gray color.

15. SUMMARY OF NON-CLINICAL TESTING

Biocompatibility

Biocompatibility Testing according to ISO 10993-1:2018, the nature of body contact for the proposed device is Surface Device and duration of contact is A-Limited (≤24h). The following tests for the proposed device were conducted to evaluate the biocompatibility of Nitrile Disposable Examination Gloves as per Guidance for Industry and FDA Staff-Medical Guidance Manual issued on January 22, 2008.

ISO 10993-23: Primary Skin Irritation
ISO 10993-10: Dermal Sensitization
· ISO 10993-11: Systemic Toxicity

Performance Testing

Physical Performance testing of the proposed device were conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application testing was conducted to support the addition of the labeling claim. Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (2023) Standard Practice for Assessment of resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs and fentanyl citrate.

To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance to the relevant test methods cited below:

ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
• ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D6978-05 Standard Practice for Assessment of resistance of Medical Gloves to Permeation by . Chemotherapy Drugs

13

Image /page/13/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the name "Owens & Minor" in gray.

For the test result, we can find the product can meet the requirements as its intended use indicated.

Test Method	Standard	Acceptance Criteria	Results
Dimensions
(Length) (Width)
(Thickness)	ASTM D6319		PASS
	Length	≥230 mm
	Palm Width Size	X-Small: 60 – 80 mm
Small: 70 - 90 mm
Med: 85–105 mm
Large: 100 - 120 mm
X-Large: 110-130 mm
XX-Large: 120-140 mm
	Finger thickness	≥0.05 mm
	Palm thickness	≥0.05 mm
	Cuff thickness	≥0.05 mm
Physical Properties	ASTM D 6319	AQL 4.0
Before Aging
Tensile Strength: ≥14 MPa
Ultimate elongation: ≥500%
After Aging
Tensile Strength: ≥14 MPa
Ultimate elongation: ≥400%	PASS
Freedom from
Pinholes	ASTM D 6319
ASTM D 5151	AQL 2.5%
No leakage	PASS
Residual Powder	ASTM D 6124
ASTM D 6319	≤ 2 mg / glove	PASS
Permeation by
Chemotherapy Drugs	ASTM D6978	Refer to the above
table	PASS
Test for irritation	ISO 10993, Part 23	No dermal
irritation
reactions	PASS
Test for acute
systemic toxicity	ISO 10993, Part 11	Under the conditions
of the study, the
device extract does
not induce acute
systemic toxicity
response.	PASS
Test for skin
sensitization	ISO 10993, Part 10	No dermal reactions
indicative of delayed
contact
hypersensitivity.	PASS

14

Image /page/14/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the name "Owens & Minor" in a light gray color. The letters "OM" have horizontal lines going through them.

CLINICAL TEST CONCLUSION No clinical study is included in this submission.

17. CONCLUSION

The conclusion drawn from the nonclinical tests demonstrates that the subject device in K242558, Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K220373.