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. This latex glove contains 50 micrograms or less of total water extractable protein per gram. In addition, this glove has been tested for use with chemotherapy drugs.

Device Description

Positive Touch Powder Free Examination Gloves With Protein and Chemotherapy Labeling Claim are formulated using latex and are coated with a Polymer coating. These gloves are offered non-sterile in sizes X-small, Small, Medium, Large and X-large.

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for "Positive Touch Powder-Free Latex Examination Gloves With Protein & Chemotherapy Labeling Claim." As such, it reports on a device, not an algorithm or AI. Therefore, most of the requested fields are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
Primary Skin Irritation	(Not explicitly stated, but expected to be non-irritating)	Glove does not display irritation potential.
Guinea Pig Maximization	(Not explicitly stated, but expected to be non-sensitizing)	Glove does not display sensitization potential.
Ultimate Elongation & Tensile Strength	Meets or exceeds requirements per ASTM D3578-01 for rubber examination gloves.	Glove meets or exceeds requirements for rubber examination gloves per ASTM D3578-01.
Barrier Defects	Meets or exceeds requirements per 21 CFR §800.20 and ASTM D3578-01, AQL=2.5.	Glove meets or exceeds requirements per 21 CFR §800.20 and ASTM D3578-01, AQL=2.5.
Powder Level	Meets powder level requirements for "Powder Free" designation per ASTM D 3578-01.	Glove meets powder level requirements for "Powder Free" designation per ASTM D 3578-01.
Protein Labeling Claim	50 microgram or less of total water extractable protein per gram of glove.	Glove meets requirements for protein claim of 50 microgram or less of total water extractable protein per gram of glove using the ASTM Lowry test method (ASTM 5712-95).
Chemotherapy Drug Resistance	(Implied: tested for use with chemotherapy drugs according to ASTM F 739-99a)	This glove has been tested for use with chemotherapy drugs. (Further details would be in the ASTM F 739-99a report, which is not provided here).

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for each of the tests (e.g., how many gloves were tested for barrier defects, how many animals for irritation/sensitization). The data provenance is internal to the manufacturer, Allegiance Healthcare Corporation, based in McGaw Park, Illinois, USA. The study is prospective in nature, as it is a pre-market notification for a medical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device (gloves), not an AI/algorithm-based diagnostic or prognostic tool that requires expert interpretation for establishing ground truth. The tests are laboratory and physical performance tests against established standards.

4. Adjudication method for the test set

Not applicable. The tests performed are objective laboratory and physical measurements, not subjective evaluations requiring expert 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 a medical device (gloves), not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (gloves), not an algorithm.

7. The type of ground truth used

The ground truth for the device's performance is based on established industry standards and regulatory requirements, specifically:

ASTM D3578-01 (Standard Specification for Rubber Examination Gloves) for physical characteristics (elongation, tensile strength, barrier defects, powder level).
21 CFR §800.20 (Barriers) for barrier defects.
ASTM 5712-95 (Standard Test Method for Protein in Natural Rubber Latex Devices) for protein content.
ASTM F 739-99a (Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact) for chemotherapy drug resistance.
Standard toxicological testing methods (Primary Skin Irritation, Guinea Pig Maximization) for biocompatibility.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI/Machine Learning model that requires a training set. The "training" here refers to the development and manufacturing processes of the glove to meet specified standards.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the device's manufacturing and design would be the specifications and performance requirements derived from the standards listed above.

Summary

{0}------------------------------------------------

Ko24292

Image /page/0/Picture/2 description: The image shows the word "Allegiance" in a bold, stylized font. To the left of the word is a symbol resembling a plus sign, but it is made up of many small squares. The word "Allegiance" is written in all lowercase letters, and the letters are connected to each other.

STATEMENT OF SAFETY AND EFFECTIVENESS XIII.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN & CHEMOTHERAPY LABELING CLAIM

Manufacturer:	Allegiance Healthcare Corporation1500 Waukegan RoadMcGaw Park, Illinois USA
Regulatory Affairs Contact:	Erica Sethi1500 Waukegan Road, Bldg. WMMcGaw Park, IL 60085
Telephone:	(847) 785-3337
Date Summary Prepared:	11/20/02
Common Name:	Patient Examination Glove
Classification:	Glove, Examination (Latex)
Predicate Devices:	Positive Touch Powder-Free Latex Examination Gloves With Proteinand Chemotherapy Labeling Claim
Description:	Positive Touch Powder Free Examination Gloves With Protein andChemotherapy Labeling Claim are formulated using latex and are coatedwith a Polymer coating. These gloves are offered non-sterile in sizes X-small, Small, Medium, Large and X-large.
Intended Use:	Positive Touch Powder-Free Latex Examination Gloves With Protein andChemotherapy Labeling Claim are disposable devices intended formedical purposes that are worn on the examiner's hands or fingers toprevent contamination between patient and examiner. These gloves havebeen tested for use with chemotherapy drugs using ASTM F 739-99a.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the word "Allegiance" in a bold, stylized font. To the left of the word is a symbol resembling a plus sign, but it is made up of many small dots. The text is in black and the background is white.

STATEMENT OF SAFETY AND EFFECTIVENESS XIII.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (con't) POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM

Substantial Equivalence	Positive Touch Powder Free Examination Gloves With Protein andChemotherapy Labeling Claim are substantially equivalent to PositiveTouch Powder-Free Latex Examination Gloves in that they provide thefollowing characteristics:
	- intended use
	- size, design, product features
	- made of natural rubber latex

physical characteristics

Summary of Test Results:

Test	Result
Primary Skin Irritation	Glove does not display irritation potential.
Guinea Pig Maximization	Glove does not display sensitization potential.
Ultimate Elongation& Tensile Strength	Glove meets or exceeds requirements for rubberexamination gloves per ASTM D3578-01.
Barrier Defects	Glove meets or exceeds requirements per 21 CFR§800.20 and ASTM D3578-01, AQL=2.5.
Powder Level	Glove meets powder level requirements for "Powder Free"designation per ASTM D 3578-01.
Protein Labeling Claim	Glove meets requirements for protein claim of 50 microgram or lessof total water extractable protein per gram of glove using the ASTMLowry test method (ASTM 5712-95).

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 9 2003

Ms. Erica Sethi Manager, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road, Building WM McGaw Park, Illinois 60085

Re: K024292

Trade/Device Name: Positive Touch Powder-Free Latex Examination Gloves Contains 50 Micrograms or Less of Total Extractable Protein Per Gram and Chemotherapy Claim Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: November 20, 2002 Received: December 24, 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.

{3}------------------------------------------------

Page 2 - Ms. Sethi

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); 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). 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) you may obtain. 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 vour Timothy

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

{4}------------------------------------------------

K024 292

Allegiance

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2460

Page 1 of 1

Applicant:	Allegiance Healthcare Corporation
510(k) Number:	K024292
Device Name:	Positive Touch Powder-Free Latex Examination Gloves With Protein,Chemotherapy Labeling Claim
Indications For Use:	A patient examination glove is a disposable device intended for medicalpurposes that is worn on the examiner's hand or finger to prevent contaminationbetween patient and examiner. This latex glove contains 50 micrograms or lessof total water extractable protein per gram. In addition, this glove has beentested for use with chemotherapy drugs.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The Counter Use or (Per 21 CFR 801.109) (Division Sign-Off) Hospital. Division of Anesthesiolog Infection Control, D

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.