A 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. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.

Device Description

Nitrile Powder-Free Examination Gloves are formulated using nitrile and offered powder-free.

AI/ML Overview

This document describes the safety and effectiveness of "Nitrile Powder-Free Examination Gloves" and does not relate to artificial intelligence or machine learning devices. Therefore, most of the requested information (e.g., sample sizes for test and training sets, expert qualifications, MRMC studies, standalone algorithm performance, adjudication methods, details about AI-related ground truth) is not applicable to this submission.

However, I can extract and present the information that is relevant to the acceptance criteria and the summary of testing for these medical gloves.

Acceptance Criteria and Device Performance for Nitrile Powder-Free Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Primary Skin Irritation	Not explicitly stated, but implied as "no irritation"	Gloves show no irritation.
Guinea Pig Maximization	Not explicitly stated, but implied as "no potential for irritation"	Gloves do not display any potential for irritation.
Tensile Strength	Meet or exceed requirements per ASTM D6319-00a	Gloves meet or exceed requirements per ASTM D6319-00a.
Barrier Defects	Meet or exceed requirements per 21 CFR§800.20 and ASTM D6319-00a	Gloves meet or exceed requirements per 21 CFR§800.20 and ASTM D6319-00a.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: Not specified in the provided document for any of the tests.
Data Provenance: Not specified. Standard practice for these tests is typically prospective testing of manufactured batches.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable as this is not an AI/ML device requiring expert ground truth for interpretation of complex data. The "ground truth" for glove performance tests is determined by standardized physical and biological testing methodologies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. These are laboratory tests with objective outcomes based on established standards, not subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" is established by the specified standards and regulations:
- Primary Skin Irritation & Guinea Pig Maximization: Biological tests to assess skin reactions, interpreted by trained personnel following toxicological guidelines (implied).
- Tensile Strength: Objective measurement against specifications defined in ASTM D6319-00a.
- Barrier Defects: Objective measurement against specifications defined in 21 CFR§800.20 (Pinholes in Medical Gloves) and ASTM D6319-00a.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device.

Summary of Safety and Effectiveness Explanation (Based on Provided Text):

The "Nitrile Powder-Free Examination Gloves" were determined to be substantially equivalent to the predicate device (Flexam Nitrile T Ambi Examination Gloves, Allegiance Healthcare Corp.) based on shared characteristics and testing results. The device's safety and effectiveness were demonstrated by laboratory testing confirming:

No primary skin irritation.
No potential for irritation in a guinea pig maximization test.
Conformity to or exceeding the tensile strength requirements of ASTM D6319-00a.
Conformity to or exceeding the barrier defect requirements of 21 CFR§800.20 and ASTM D6319-00a.

These tests ensure the gloves perform their intended function of preventing contamination and protecting the wearer, without causing adverse biological reactions, and meet the mechanical and barrier integrity standards for medical examination gloves.

Summary

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XIII. SUMMARY OF SAFETY AND EFFECTIVENESS

Allegiance

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS NITRILE POWDER-FREE EXAMINATION GLOVES

1222

Applicant/Sponsor: Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085

Regulatory Affairs Contact: Erica Sethi Allegiance Healthcare Corporation 1500 Waukegan Road, Bldg. WM McGaw Park, IL 60085

Telephone: (847) 785-3337

Date Summary Prepared: August 9, 2002

Product Trade Name: Undetermined

Common Name: Examination Glove

Classification: Patient Examination Glove

Predicate Devices: Flexam Nitrile T Ambi Examination Gloves, Allegiance Healthcare Corp.

Description: Nitrile Powder-Free Examination Gloves are formulated using nitrile and offered powder-free.

Intended Use: These examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.

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Substantial Equivalence: Nitrile Powder-Free Examination Gloves are substantially equivalent to Allegiance Healthcare's Flexam Nitrile T Ambi Examination Gloves in that they provide the following characteristics:

same intended use
same sizes
both made of nitrile
both offered beaded and powder-free
both worn to protect the wearer against exposure to chemotherapy drugs

Summary of Testing:

Test	Result
Primary Skin Irritation	Gloves show no irritation.
Guinea Pig Maximization	Gloves do not display any potential for irritation.
Tensile Strength	Gloves meet or exceed requirements per ASTM D6319-00a.
Barrier Defects	Gloves meet or exceed requirements per 21 CFR§800.20and ASTM D6319-00a.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design of three abstract human figures, possibly representing a family or community.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 11 2002

Ms. Erica Sethi Quality & Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road McGraw Park, Illinois 60085

Re: K022765

Trade/Device Name: Powder-Free Blue Nitrile Examination Gloves with Tested For Use with Chemotherapy Drugs Labeling Claim Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: 80 LZA Dated: September 4, 2002 Received: September 6, 2002

Dear Ms. Sethi:

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 (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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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.

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Page 2 - Ms. Sethi

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Palaciu Coccinitffe

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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cGaw Park, Illinois 60085-6 FAX: 847 785 7

Page 1 of 1

Allegiance Healthcare Corporation Applicant:

KO22765 510(k) Number:

Undetermined Powder-Free Blue Nitrile Examination Device Name: Glove with Tested For use with Citem THERAPY DRUGS LABELING CLAIM Indications For Use: A 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. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use

Qiu S. Lin

n of Anesthesiology, General Hospital, n Control, Dental De

510(k) Number: K022765

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.