K Number

Device Name

GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]

Manufacturer

Glove One, LLC

Date Cleared

2025-06-03

(175 days)

Product Code

LZA LZC OPJ QDO

Regulation Number

880.6250

Intended Use

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. These gloves were tested for use with chemotherapy drugs and fentanyl citrate per ASTM D6978-05 (Reapproved 2019) Standard Practices for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Description

GLOVEONE™, Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for Use with Chemotherapy Drugs and Fentanyl] are Class I patient examination gloves, bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all current specifications listed under the ASTM D6319-19 (2023), Standard Specification for Nitrile Examination Gloves for Medical Application and comply with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs per ASTM D6978-05. The powder-free gloves are made from Nitrile (NBR) latex and are green in color. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff, and single use only. The product is not manufactured using natural rubber latex. GLOVEONE™, Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for Use with Chemotherapy Drugs and Fentanyl] include glove sizes: X-Small, Small, Medium, Large, and X-Large.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K193666

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No.
This document describes medical examination gloves, which are physical objects and do not contain any software or computational intelligence.

Therapeutic

No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.

Diagnostic

This device is a patient examination glove, intended to prevent contamination between patient and examiner. It is a barrier device, not one used for diagnosis.

SaMD (Software as a Medical Device)

The device is a physical product (nitrile examination gloves) and does not contain any software components. The summary describes physical properties, test results for material performance, and biocompatibility, not software functions.

IVD (In Vitro Diagnostic)

No.
This device is a patient examination glove, which is a barrier device for medical purposes. It does not perform any in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

LZA, LZC, OPJ, QDO

Device Description

GLOVEONE™, Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for Use with Chemotherapy Drugs and Fentanyl] are Class I patient examination gloves, bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all current specifications listed under the ASTM D6319-19 (2023), Standard Specification for Nitrile Examination Gloves for Medical Application and comply with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs per ASTM D6978-05. The powder-free gloves are made from Nitrile (NBR) latex and are green in color. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff, and single use only. The product is not manufactured using natural rubber latex.
GLOVEONE™, Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for Use with Chemotherapy Drugs and Fentanyl] include glove sizes: X-Small, Small, Medium, Large, and X-Large.

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 / Not Found

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)

Biocompatibility Testing

ISO 10993-23: 2021 Biological Evaluation of Medical Devices, Part 23 – Tests for Irritation: Pass - Under the conditions of the study, the subject device is not a primary skin irritant.
ISO 10993-10:2021 Biological Evaluation of Medical Devices Part 10: Test for Skin Sensitization: Pass - Under the conditions of the study, the subject device is not a primary skin sensitizer.
ISO 10993-5: 2009 Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity: Failed - Under the conditions of the study, the subject device is cytotoxic.
ISO 10993-11: 2017 Biological Evaluation of Medical Devices Part 11: Test for Systemic Toxicity: Pass - Under the conditions of the study, the subject device does not exhibit acute systemic toxicity.

Specification Performance Testing

Dimension (length, width, thickness): Test Method: ASTM D6319-19 (2023), Inspection Level: S-2, Acceptance Criteria: AQL 4.0, Results: Pass.
Tensile strength and Ultimate Elongation: Test Method: ASTM D6319-19 (2023), Inspection Level: S-2, Acceptance Criteria: AQL 4.0, Results: Pass.
Water Leak: Test Method: ASTM D5151-19 (2023) and ASTM D6319-19 (2023), Inspection Level: G-1, Acceptance Criteria: AQL 2.5, Results: Pass.
Powder Residue: Test Method: ASTM D6124-06 (2022), Inspection Level: N/A, Acceptance Criteria: 240 min unless specified):**
- Cisplatin 1 mg/ml (1,000 ppm)
- Cyclophosphamide 20 mg/ml (20,000 ppm)
- Dacarbazine 10 mg/ml (10,000 ppm)
- Doxorubicin HCL 2 mg/ml (2,000 ppm)
- Etoposide 20 mg/ml (20,000 ppm)
- Fluorouracil 50 mg/ml (50,000 ppm)
- Ifosamide 50 mg/ml (50,000 ppm)
- Mitroxantrone HCL 2 mg/ml (2,000 ppm)
- Paclitaxel 6 mg/ml (16,000 ppm)
- Vincristine Sulfate 1 mg/ml (1,000 ppm)
- Carmustine 3.3 mg/ml (3,000 ppm): 12.3 minutes (21.2, 12.8, 12.6)
- Thiotepa 10 mg/ml (10,000 ppm): 13.4 minutes (17.1, 15.4, 13.4)
Fentanyl Tested:
- Fentanyl Citrate Injection, 100 mcg/2 mL: >240 min

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

Not Found

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.

K193666

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.

Not Found

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

FDA 510(k) Clearance Letter - GLOVEONE™ Powder-Free Nitrile Examination Gloves

Page 1

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

Doc ID # 04017.07.05

June 3, 2025

Glove One, LLC
℅ Terrie Heidemann
Consultant
Terrie M Heidemann
3085 N Broadway
Escondido, California 92026

Re: K243796
Trade/Device Name: GLOVEONE™ Powder-Free Nitrile Examination Gloves - Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]
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: April 28, 2025
Received: May 1, 2025

Dear Terrie Heidemann:

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.

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K243796 - Terrie Heidemann Page 2

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

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

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

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

Page 3

K243796 - Terrie Heidemann 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,

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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K243796

Device Name
GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]

Indications for Use (Describe)

Chemotherapy Drug Tested

Cisplatin 1 mg/ml (1,000 ppm) - Breakthrough Time (minutes): >240 min
Cyclophosphamide 20 mg/ml (20,000 ppm) - >240 min
Dacarbazine 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
Ifosamide 50 mg/ml (50,000 ppm) - >240 min
Mitroxantrone HCL 2 mg/ml (2,000 ppm) - >240 min
Paclitaxel 6 mg/ml (16,000 ppm) - >240 min
Vincristine Sulfate 1 mg/ml (1,000 ppm) - >240 min
Carmustine 3.3 mg/ml (3,000 ppm) - 12.3 minutes
Thiotepa 10 mg/ml (10,000 ppm) > 240 min - 13.4 minutes

Fentanyl Tested
Fentanyl Citrate Injection, 100 mcg/2 mL - Breakthrough Time (minutes): >240 min

WARNING: The following drugs have low permeation times:
Carmustine (BCNU) (3.3 mg/ml) 12.3 minutes
Thiotepa (THT) (10.0 mg/ml) 13.4 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 1 of 2

Page 5

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 2 of 2

Page 6

K243796
Page 1 of 13

510(k) SUMMARY

[AS REQUIRED BY 21CFR807.92(c)]

Summary Preparation Date: 29May2025

Type of 510(k) Submission
Traditional

Device Classification: Class I

510(k) Number: K243796

Device Name/Classification

Name of Device: GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]

Common Name: Patient Examination Glove, Specialty

Classification Name: Polymer Patient Exam Glove, Medical Gloves with Chemotherapy/Fentanyl Labeling Claims

Product Code: LZA, LZC, OPJ, QDO

Classification Panel: General Hospital

Regulation #: 21 CFR 880.6250

Predicate Device

Medline Powder-Free Nitrile Examination Gloves(Tested for use with Chemotherapy Drugs and Fentanyl)- Regular Cuff – K193666

Product Code: LZA, OPJ, QDO

Applicant Name:
Medline Industries, Inc.
Three Lakes Drive
Northfield, IL 60093

Registration Number: 1417592

Page 7

K243796

510(k) SUMMARY

[AS REQUIRED BY 21CFR807.92(c)]

Submitter / 510(k) Sponsor

Summary Preparation Date: 29May2025

Type of 510(k) Submission
Traditional

Device Classification: Class I

510(k) Number: K243796

Device Name/Classification

Name of Device: GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]

Common Name: Patient Examination Glove, Specialty

Classification Name: Polymer Patient Exam Glove, Medical Gloves with Chemotherapy/Fentanyl Labeling Claims

Product Code: LZA, LZC, OPJ, QDO

Classification Panel: General Hospital

Regulation #: 21 CFR 880.6250

Predicate Device

Medline Powder-Free Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)- Regular Cuff – K193666

Product Code: LZA, OPJ, QDO

Applicant Name:
Medline Industries, Inc.
Three Lakes Drive
Northfield, IL 60093

Registration Number: 1417592

Page 1 of 13

Page 8

K243796
Page 2 of 13

Device Description

GLOVEONE™, Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for Use with Chemotherapy Drugs and Fentanyl] include glove sizes: X-Small, Small, Medium, Large, and X-Large.

Table 1: GLOVEONE™ Powder-Free Nitrile Examination Gloves

Glove Type	Model Number	Size	Glove Count
GLOVEONE™ Powder Free, Nitrile Exam Glove – Nonsterile	GO1111-100	Extra-Small	100
	GO1111-200		200
	GO1112-100	Small	100
	GO1112-200		200
	GO1113-100	Medium	100
	GO1113-200		200
	GO1114-100	Large	100
	GO1114-200		200
	GO1115-100	Extra-Large	100
	GO1115-200		200

The gloves are designed and manufactured in accordance with the ASTM D6319-19 (2023) Standard Specification for Nitrile Examination Gloves for Medical Application and are tested for use with chemotherapy drugs as well as for use with Fentanyl per ASTM D6978-05 (Reapproved 2019).

Physical Description

GLOVEONE™ (Green Colored), Nitrile, powder free, non-sterile, textured fingertips, ambidextrous, beaded cuff, examination gloves with online chlorination on the grip side.

Indications for Use

Page 9

K243796

Device Description

GLOVEONE™, Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for Use with Chemotherapy Drugs and Fentanyl] include glove sizes: X-Small, Small, Medium, Large, and X-Large.

Table 1: GLOVEONE™ Powder-Free Nitrile Examination Gloves

Glove Type	Model Number	Size	Glove Count
GLOVEONE™ Powder Free, Nitrile Exam Glove – Non-sterile	GO1111-100	Extra-Small	100
	GO1111-200		200
	GO1112-100	Small	100
	GO1112-200		200
	GO1113-100	Medium	100
	GO1113-200		200
	GO1114-100	Large	100
	GO1114-200		200
	GO1115-100	Extra-Large	100
	GO1115-200		200

Physical Description

GLOVEONE™ (Green Colored), Nitrile, powder free, non-sterile, textured fingertips, ambidextrous, beaded cuff, examination gloves with online chlorination on the grip side.

Indications for Use

Page 2 of 13

Page 10

K243796
Page 3 of 13

Chemotherapy Drug Tested	Breakthrough Time (minutes)
Cisplatin 1 mg/ml (1,000 ppm)	> 240 min
Cyclophosphamide 20 mg/ml (20,000 ppm)	> 240 min
Dacarbazine 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
Ifosamide 50 mg/ml (50,000 ppm)	> 240 min
Mitroxantrone HCL 2 mg/ml (2,000 ppm)	> 240 min
Paclitaxel 6 mg/ml (16,000 ppm)	> 240 min
Vincristine Sulfate 1 mg/ml (1,000 ppm)	>240 min
Carmustine 3.3 mg/ml (3,000 ppm)	12.3 minutes(21.2, 12.8, 12.6)
Thiotepa 10 mg/ml (10,000 ppm)	13.4 minutes(17.1, 15.4, 13.4)

Fentanyl Tested	Breakthrough Time (minutes)
Fentanyl Citrate Injection, 100 mcg/2 mL	>240 min

WARNING: Not for use with Carmustine or Thiotepa

The following drugs have low permeation times:
Carmustine (BCNU) (3.3 mg/ml) 12.3 minutes
Thiotepa (THT) (10.0 mg/ml) 13.4 minutes

Page 11

K243796

Chemotherapy Drug Tested	Breakthrough Time (minutes)
Cisplatin 1 mg/ml (1,000 ppm)	> 240 min
Cyclophosphamide 20 mg/ml (20,000 ppm)	> 240 min
Dacarbazine 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
Ifosamide 50 mg/ml (50,000 ppm)	> 240 min
Mitroxantrone HCL 2 mg/ml (2,000 ppm)	> 240 min
Paclitaxel 6 mg/ml (16,000 ppm)	> 240 min
Vincristine Sulfate 1 mg/ml (1,000 ppm)	>240 min
Carmustine 3.3 mg/ml (3,000 ppm)	12.3 minutes (21.2, 12.8, 12.6)
Thiotepa 10 mg/ml (10,000 ppm)	13.4 minutes (17.1, 15.4, 13.4)

Fentanyl Tested	Breakthrough Time (minutes)
Fentanyl Citrate Injection, 100 mcg/2 mL	>240 min

WARNING: Not for use with Carmustine or Thiotepa

The following drugs have low permeation times:

Carmustine (BCNU) (3.3 mg/ml) 12.3 minutes

Thiotepa (THT) (10.0 mg/ml) 13.4 minutes

Page 3 of 13

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K243796
Page 4 of 13

Comparison of Technological Characteristics

Device Characteristics	Proposed Device	Medline Predicate Device	Comparison Analysis
Product Name	GLOVEONE™, Powder Free, Nitrile Examination Glove – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]	Medline Powder-Free Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) – Regular Cuff	N/A
510(k)	K243796	K193666	N/A
Product Owner	GLOVEONE™	Medline Industries, Inc.	N/A
Product Code	LZA, LZC, OPJ, QDO	LZA, OPJ, QDO	Similar
Intended Use	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. These gloves were tested for use with Chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) 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. These gloves were tested for use with Chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.	Same
Regulation Number	21 CFR 880.6250	21 CFR 880.6250	Same
Materials	Powder-Free Nitrile	Powder-Free Nitrile	Same
Color	Green	Blue	Similar
Sizes	xs-small,small, medium, large, x-large	xs-small,small, medium, large, x-large	Same
Dimensions– Length	Complies with: ASTM D6319-19 (2023) 220mm min	Complies with: ASTM D6319-10 220mm min	Same
Dimensions – Width	Complies with: ASTM D6319-19 (2023) 70mm min	Complies with: ASTM D6319-10 70mm min	Same
Dimensions– Thickness	Complies with: ASTM D6319-19 (2023) Palm – 0.05 mm min Finger – 0.05mm min	Complies with: ASTM D6319-10 Palm – 0.05 mm min Finger – 0.05mm min	Same
Physical Properties	Complies with: ASTM D6319-19 (2023) minimum Tensile Strength: Before Aging ≥ 14 MPa, min After Aging ≥ 14 MPa, Min Elongation:	Complies with: ASTM D6319-10 minimum Tensile Strength: BeforeAging ≥ 14 MPa, min After Aging ≥ 14 MPa, Min Elongation:	Same

Page 13

K243796

Comparison of Technological Characteristics

Device Characteristics	Proposed Device	Medline Predicate Device	Comparison Analysis
Product Name	GLOVEONE™, Powder Free, Nitrile Examination Glove – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]	Medline Powder-Free Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) – Regular Cuff	N/A
510(k)	K243796	K193666	N/A
Product Owner	GLOVEONE™	Medline Industries, Inc.	N/A
Product Code	LZA, LZC, OPJ, QDO	LZA, OPJ, QDO	Similar
Intended Use	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. These gloves were tested for use with Chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) 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. These gloves were tested for use with Chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.	Same
Regulation Number	21 CFR 880.6250	21 CFR 880.6250	Same
Materials	Powder-Free Nitrile	Powder-Free Nitrile	Same
Color	Green	Blue	Similar
Sizes	xs-small, small, medium, large, x-large	xs-small, small, medium, large, x-large	Same
Dimensions– Length	Complies with: ASTM D6319-19 (2023) 220mm min	Complies with: ASTM D6319-10 220mm min	Same
Dimensions – Width	Complies with: ASTM D6319-19 (2023) 70mm min	Complies with: ASTM D6319-10 70mm min	Same
Dimensions– Thickness	Complies with: ASTM D6319-19 (2023) Palm – 0.05 mm min Finger – 0.05mm min	Complies with: ASTM D6319-10 Palm – 0.05 mm min Finger – 0.05mm min	Same
Physical Properties	Complies with: ASTM D6319-19 (2023) minimum Tensile Strength: Before Aging ≥ 14 MPa, min After Aging ≥ 14 MPa, Min Elongation:	Complies with: ASTM D6319-10 minimum Tensile Strength: Before Aging ≥ 14 MPa, min After Aging ≥ 14 MPa, Min Elongation:	Same

Page 4 of 13

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K243796
Page 5 of 13

Device Characteristics	Proposed Device	Medline Predicate Device	Comparison Analysis
	Before Aging 500% min. After Aging 400%, min.	Before Aging 500% min. After Aging 400%, min.
Freedom from Holes	Complies with: ASTM D6319-19 (2023) and ASTM D5151-19 G-1, AQL 1.5	Complies with: ASTMD6319-10 andASTM D5151-06 G-1, AQL 1.5	Same
Powder or Powder-Free	Powder-Free	Powder-Free	Same
Residual Powder	Complies with: ASTM D6319-19 (2023) ≤ 2 mg per glove	Complies with: ASTM D6319-10 ≤ 2 mg per glove	Same
Contact Durations	Limited ≤ 24 hours	Limited ≤ 24 hours	Same
Biocompatibility	AAMI/ANSI/ISO 10993-11: Under the conditions of the study, the subject device is not acutely toxic.	AAMI/ANSI/ISO 10993-11: Under the conditions of the study, the subject device is not acutely toxic.	Same
	AAMI/ANSI/ISO 10993-10: Under the conditions of the study, the subject device is not a primary skin sensitizer.	AAMI/ANSI/ISO 10993-10: Under the conditions of the study, the subject device is not a primary skin sensitizer.
	AAMI/ANSI/ISO 10993-23: Under the conditions of the study, the subject device is not a primary skin irritant.	AAMI/ANSI/ISO 10993-10: Under the conditions of the study, the subject device is not a primary skin irritant.
	AAMI/ANSI/ISO 10993-05: Under the conditions of the study, the subject device is cytotoxic.	AAMI/ANSI/ISO 10993-05: Under the conditions of the study, the subject device is cytotoxic.
Sterility	Non-sterile	Non-sterile	Same
Rx Only or OTC	Over the Counter	Over the Counter	Same

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Device Characteristics	Proposed Device	Medline Predicate Device	Comparison Analysis
	Before Aging 500% min. After Aging 400%, min.	Before Aging 500% min. After Aging 400%, min.
Freedom from Holes	Complies with: ASTM D6319-19 (2023) and ASTM D5151-19 G-1, AQL 1.5	Complies with: ASTMD6319-10 and ASTM D5151-06 G-1, AQL 1.5	Same
Powder or Powder-Free	Powder-Free	Powder-Free	Same
Residual Powder	Complies with: ASTM D6319-19 (2023) ≤ 2 mg per glove	Complies with: ASTM D6319-10 ≤ 2 mg per glove	Same
Contact Durations	Limited ≤ 24 hours	Limited ≤ 24 hours	Same
Biocompatibility	AAMI/ANSI/ISO 10993-11: Under the conditions of the study, the subject device is not acutely toxic.	AAMI/ANSI/ISO 10993-11: Under the conditions of the study, the subject device is not acutely toxic.	Same
	AAMI/ANSI/ISO 10993-10: Under the conditions of the study, the subject device is not a primary skin sensitizer.	AAMI/ANSI/ISO 10993-10: Under the conditions of the study, the subject device is not a primary skin sensitizer.
	AAMI/ANSI/ISO 10993-23: Under the conditions of the study, the subject device is not a primary skin irritant.	AAMI/ANSI/ISO 10993-10: Under the conditions of the study, the subject device is not a primary skin irritant.
	AAMI/ANSI/ISO 10993-05: Under the conditions of the study, the subject device is cytotoxic.	AAMI/ANSI/ISO 10993-05: Under the conditions of the study, the subject device is cytotoxic.
Sterility	Non-sterile	Non-sterile	Same
Rx Only or OTC	Over the Counter	Over the Counter	Same

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Tested Chemotherapy Drugs and Fentanyl Citrate
• Cisplatin 1 mg/ml (1,000 ppm)	• Cisplatin 1 mg/ml (1,000 ppm)	• Cisplatin 1 mg/ml (1,000 ppm)
• Cyclophosphamide 20 mg/ml (20,000 ppm)	• Cyclophosphamide 20 mg/ml (20,000 ppm)	• Cyclophosphamide 20 mg/ml (20,000 ppm)
• Dacarbazine 10 mg/ml (10,000 ppm)	• Dacarbazine 10 mg/ml (10,000 ppm)	• Dacarbazine 10 mg/ml (10,000 ppm)
• Doxorubicin HCL 2 mg/ml (2,000 ppm)	• Doxorubicin HCL 2 mg/ml (2,000 ppm)	• Doxorubicin HCL 2 mg/ml (2,000 ppm)
• Etoposide 20 mg/ml (20,000 ppm)	• Etoposide 20 mg/ml (20,000 ppm)	• Etoposide 20 mg/ml (20,000 ppm)
• Fluorouracil 50 mg/ml (50,000 ppm)	• Fluorouracil 50 mg/ml (50,000 ppm)	• Fluorouracil 50 mg/ml (50,000 ppm)
• Ifosamide 50 mg/ml (50,000 ppm)	• Ifosamide 50 mg/ml (50,000 ppm)	• Ifosamide 50 mg/ml (50,000 ppm)
• Mitroxantrone HCL 2 mg/ml (2,000 ppm)	• Mitroxantrone HCL 2 mg/ml (2,000 ppm)	• Mitroxantrone HCL 2 mg/ml (2,000 ppm)

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Tested Chemotherapy Drugs and Fentanyl Citrate
• Cisplatin 1 mg/ml (1,000 ppm)	• Cisplatin 1 mg/ml (1,000 ppm)	• Cisplatin 1 mg/ml (1,000 ppm)
• Cyclophosphamide 20 mg/ml (20,000 ppm)	• Cyclophosphamide 20 mg/ml (20,000 ppm)	• Cyclophosphamide 20 mg/ml (20,000 ppm)
• Dacarbazine 10 mg/ml (10,000 ppm)	• Dacarbazine 10 mg/ml (10,000 ppm)	• Dacarbazine 10 mg/ml (10,000 ppm)
• Doxorubicin HCL 2 mg/ml (2,000 ppm)	• Doxorubicin HCL 2 mg/ml (2,000 ppm)	• Doxorubicin HCL 2 mg/ml (2,000 ppm)
• Etoposide 20 mg/ml (20,000 ppm)	• Etoposide 20 mg/ml (20,000 ppm)	• Etoposide 20 mg/ml (20,000 ppm)
• Fluorouracil 50 mg/ml (50,000 ppm)	• Fluorouracil 50 mg/ml (50,000 ppm)	• Fluorouracil 50 mg/ml (50,000 ppm)
• Ifosamide 50 mg/ml (50,000 ppm)	• Ifosamide 50 mg/ml (50,000 ppm)	• Ifosamide 50 mg/ml (50,000 ppm)
• Mitroxantrone HCL 2 mg/ml (2,000 ppm)	• Mitroxantrone HCL 2 mg/ml (2,000 ppm)	• Mitroxantrone HCL 2 mg/ml (2,000 ppm)

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Device Characteristics	Proposed Device	Medline Predicate Device	Comparison Analysis
	mg/ml (2,000 ppm)	mg/ml (2,000 ppm)
	• Paclitaxel 6 mg/ml (16,000 ppm)	• Paclitaxel 6 mg/ml (16,000 ppm)
	• Vincristine Sulfate 1 mg/ml (1,000 ppm)	• Vincristine Sulfate 1 mg/ml (1,000 ppm)
	• Carmustine 3.3 mg/ml (3,000 ppm)	• Carmustine 3.3 mg/ml (3,000 ppm)
	• Thiotepa 10 mg/ml (10,000 ppm)	• Thiotepa 10 mg/ml (10,000 ppm)
	• Fentanyl Citrate Injection 100 mcg/2 ml	• Fentanyl Citrate Injection 100 mcg/2 ml
		Medline evaluated 38 additional drugs which are not being claimed as part of the GLOVEONE™ submission
		• Arsenic Trioxide 1.0 mg/ml (1,000 ppm)
		• Azacitidine (Vidaza) 25.0 mg/ml (25,000 ppm0
		• Bendamustine 5.0 mg/ml (5,000 ppm)
		• Bleomycin 15.0 mg/ml (15,000 ppm)
		• Bortezomib 1.0 mg/ml (1,000 ppm)
		• Busulfan 6.0 mg/ml (6,000 ppm)
		• Carboplatin 10 mg/ml (10,000 ppm)
		• Carfilzomib 2.0 mg/ml (2,000 ppm)
		• Cetuximab 2.0 mg/ml (2,000 ppm)
		• Cytarabine 100.0 mg/ml (100,000 ppm)
		• Cytovene 10.0 mg/ml (10,000 ppm)
		• Daunorubicin 5.0 mg/ml (5,000 ppm)
		• Decitabine 5.0 mg/ml (5,000 ppm)

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Device Characteristics	Proposed Device	Medline Predicate Device	Comparison Analysis
	mg/ml (2,000 ppm)	mg/ml (2,000 ppm)
	• Paclitaxel 6 mg/ml (16,000 ppm)	• Paclitaxel 6 mg/ml (16,000 ppm)
	• Vincristine Sulfate 1 mg/ml (1,000 ppm)	• Vincristine Sulfate 1 mg/ml (1,000 ppm)
	• Carmustine 3.3 mg/ml (3,000 ppm)	• Carmustine 3.3 mg/ml (3,000 ppm)
	• Thiotepa 10 mg/ml (10,000 ppm)	• Thiotepa 10 mg/ml (10,000 ppm)
	• Fentanyl Citrate Injection 100 mcg/2 ml	• Fentanyl Citrate Injection 100 mcg/2 ml
		Medline evaluated 38 additional drugs which are not being claimed as part of the GLOVEONE™ submission
		• Arsenic Trioxide 1.0 mg/ml (1,000 ppm)
		• Azacitidine (Vidaza) 25.0 mg/ml (25,000 ppm0
		• Bendamustine 5.0 mg/ml (5,000 ppm)
		• Bleomycin 15.0 mg/ml (15,000 ppm)
		• Bortezomib 1.0 mg/ml (1,000 ppm)
		• Busulfan 6.0 mg/ml (6,000 ppm)
		• Carboplatin 10 mg/ml (10,000 ppm)
		• Carfilzomib 2.0 mg/ml (2,000 ppm)
		• Cetuximab 2.0 mg/ml (2,000 ppm)
		• Cytarabine 100.0 mg/ml (100,000 ppm)
		• Cytovene 10.0 mg/ml (10,000 ppm)
		• Daunorubicin 5.0 mg/ml (5,000 ppm)
		• Decitabine 5.0 mg/ml (5,000 ppm)

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Device Characteristics	Proposed Device	Medline Predicate Device	Comparison Analysis
		• Docetaxel 10.0 mg/ml (10,000 ppm)
		• Epirubicin (Ellence) 2.0 mg/ml (2,000 ppm)
		• Fludarabine 25.0 mg/ml (25,000 ppm)
		• Fulvestrant 50.0 mg/ml (50,000 ppm)
		• Gemcitabine (Gemzar) 38.0 mg/ml (38,000 ppm)
		• Idarubicin 1.0 mg/ml (1,000 ppm)
		• Irinotecan 20.0 mg/ml (20,000 ppm)
		• Mechlorethamine HCL 1.0 mg/ml (1,000 ppm)
		• Melphalan 5.0 mg/ml (5,000 ppm)
		• Methotrexate 25.0 mg/ml (25,000 ppm)
		• Mitomycin C 0.5 mg/ml (50 ppm)
		• Oxaliplatin 2.0 mg/ml (2,000 ppm)
		• Paraplatin 10.0 mg/ml (10,000 ppm)
		• Pemetrexed Disodium 25.0 mg/ml (25,000 ppm)
		• Pertuzumab 30.0 mg/ml (30,000 ppm)
		• Raltitrexed 0.5 mg/ml (500 ppm)
		• Retrovir 10 mg/ml (10,000 ppm)
		• Rituximab 10 mg/ml (10,000 ppm)
		• Temsirolimus 25.0 mg/ml (25,000 ppm)
		• Topotecan HCl 1.0 mg/ml (1,000 ppm)
		• Trastuzumab 21.0 mg/ml (21,000 ppm)
		• Trisonex 1.0 mg/ml (1,000 ppm)
		• Vinblastine 1 mg/ml

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Device Characteristics	Proposed Device	Medline Predicate Device	Comparison Analysis
		• Docetaxel 10.0 mg/ml (10,000 ppm)
		• Epirubicin (Ellence) 2.0 mg/ml (2,000 ppm)
		• Fludarabine 25.0 mg/ml (25,000 ppm)
		• Fulvestrant 50.0 mg/ml (50,000 ppm)
		• Gemcitabine (Gemzar) 38.0 mg/ml (38,000 ppm)
		• Idarubicin 1.0 mg/ml (1,000 ppm)
		• Irinotecan 20.0 mg/ml (20,000 ppm)
		• Mechlorethamine HCL 1.0 mg/ml (1,000 ppm)
		• Melphalan 5.0 mg/ml (5,000 ppm)
		• Methotrexate 25.0 mg/ml (25,000 ppm)
		• Mitomycin C 0.5 mg/ml (50 ppm)
		• Oxaliplatin 2.0 mg/ml (2,000 ppm)
		• Paraplatin 10.0 mg/ml (10,000 ppm)
		• Pemetrexed Disodium 25.0 mg/ml (25,000 ppm)
		• Pertuzumab 30.0 mg/ml (30,000 ppm)
		• Raltitrexed 0.5 mg/ml (500 ppm)
		• Retrovir 10 mg/ml (10,000 ppm)
		• Rituximab 10 mg/ml (10,000 ppm)
		• Temsirolimus 25.0 mg/ml (25,000 ppm)
		• Topotecan HCl 1.0 mg/ml (1,000 ppm)
		• Trastuzumab 21.0 mg/ml (21,000 ppm)
		• Trisonex 1.0 mg/ml (1,000 ppm)
		• Vinblastine 1 mg/ml

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Device Characteristics	Proposed Device	Medline Predicate Device	Comparison Analysis
		(1,000 ppm)
		• Vinorelbine 10 mg/ml (10,000 ppm)
		• Zoledronic Acid 0.8 mg/ml (800 ppm)

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Device Characteristics	Proposed Device	Medline Predicate Device	Comparison Analysis
		(1,000 ppm)
		• Vinorelbine 10 mg/ml (10,000 ppm)
		• Zoledronic Acid 0.8 mg/ml (800 ppm)

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Summary of non-clinical testing

Biocompatibility Testing

Name of Test/Citation	Purpose	Acceptance Criteria	Results
ISO 10993-23: 2021 Biological Evaluation of Medical Devices, Part 23 – Tests for Irritation	Irritation Testing	Pass/Fail	Pass - Under the conditions of the study, the subject device is not a primary skin irritant
ISO 10993-10:2021 Biological Evaluation of Medical Devices Part 10: Test for Skin Sensitization	Sensitization Testing	Pass/Fail	Pass - Under the conditions of the study, the subject device is not a primary skin sensitizer
ISO 10993-5: 2009 Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity	Cytotoxicity Testing	Pass/Fail	Failed - Under the conditions of the study, the subject device is cytotoxic
ISO 10993-11: 2017 Biological Evaluation of Medical Devices Part 11: Test for Systemic Toxicity	Acute Systemic Toxicity Testing	Pass/Fail	Pass - Under the conditions of the study, the subject device does not exhibit acute systemic toxicity

Specification Performance Testing

Characteristics	Reference Test Method & Sampling	Inspection Level	Acceptance Criteria	Results
Dimension (length, width, thickness)	ASTM D6319-19 (2023)	S-2	AQL 4.0	Pass
Tensile strength and Ultimate Elongation	ASTM D6319-19 (2023)	S-2	AQL 4.0	Pass
Water Leak	ASTM D5151-19 (2023) and ASTM D6319-19 (2023)	G-1	AQL 2.5	Pass
Powder Residue	ASTM D6124-06 (2022)	N/A	240 min
Cyclophosphamide 20 mg/ml (20,000 ppm)	> 240 min
Dacarbazine 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
Ifosamide 50 mg/ml (50,000 ppm)	> 240 min
Mitroxantrone HCL 2 mg/ml (2,000 ppm)	> 240 min
Paclitaxel 6 mg/ml (16,000 ppm)	> 240 min
Vincristine Sulfate 1 mg/ml (1,000 ppm)	>240 min
Carmustine 3.3 mg/ml (3,000 ppm)	12.3 minutes(21.2, 12.8, 12.6)
Thiotepa 10 mg/ml (10,000 ppm)	13.4 minutes(17.1, 15.4, 13.4)

Fentanyl Tested	Breakthrough Time (minutes)
Fentanyl Citrate Injection, 100 mcg/2 mL	> 240 min

Summary of Clinical Testing

Clinical testing is not required for this device.

Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] are as safe, as effective and performs as well as or better than the legally marketed predicate device.

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Chemotherapy Drug Tested	Breakthrough Time (minutes)
Cisplatin 1 mg/ml (1,000 ppm)	> 240 min
Cyclophosphamide 20 mg/ml (20,000 ppm)	> 240 min
Dacarbazine 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
Ifosamide 50 mg/ml (50,000 ppm)	> 240 min
Mitroxantrone HCL 2 mg/ml (2,000 ppm)	> 240 min
Paclitaxel 6 mg/ml (16,000 ppm)	> 240 min
Vincristine Sulfate 1 mg/ml (1,000 ppm)	>240 min
Carmustine 3.3 mg/ml (3,000 ppm)	12.3 minutes (21.2, 12.8, 12.6)
Thiotepa 10 mg/ml (10,000 ppm)	13.4 minutes (17.1, 15.4, 13.4)

Fentanyl Tested	Breakthrough Time (minutes)
Fentanyl Citrate Injection, 100 mcg/2 mL	> 240 min

Summary of Clinical Testing

Clinical testing is not required for this device.

Conclusion

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