These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

Coated Sterile Latex Powder-free Surgical gloves are formulated using natural rubber latex and are coated with a nitrile coating. These are offered powder-free and sterile.

AI/ML Overview

This document describes the safety and effectiveness of "Coated Sterile Latex Powder-Free Surgical Gloves." It does not pertain to an AI device or a study involving human readers or algorithms. Therefore, much of the requested information about AI model performance, expert ground truth, adjudication methods, and sample sizes for training/test sets is not applicable.

However, I can extract information related to the acceptance criteria and the summary of testing for this medical device.

Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implicit from "meets or exceeds requirements" or regulations)	Reported Device Performance
Systemic Toxicity	Gloves should not elicit any toxic reactions to acute application.	Gloves do not elicit any toxic reactions to acute application.
Intracutaneous Reactivity	Gloves should show no reactivity.	Gloves show no reactivity.
Guinea Pig Maximization	Gloves should not display any potential for irritation.	Gloves do not display any potential for irritation.
Ultimate Elongation & Tensile Strength	Meet or exceed requirements for rubber surgical gloves per ASTM D3577-99.	Gloves meet or exceed requirements for rubber surgical gloves per ASTM D3577-99.
Barrier Defects	Exceed requirements per 21 CFR §800.20, AQL = 2.5.	Gloves exceed requirements per 21 CFR §800.20, AQL = 2.5.
Powder Level	Meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-97 (values below 4 mg of residual powder per glove).	Results generated values below 4 mg of residual powder per glove.

Information Not Applicable or Not Provided for this Device:

Sample size used for the test set and the data provenance: Not specified, as this is a physical medical device, not an AI model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Device performance is measured through physical and chemical tests, not expert consensus on images/data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For physical medical devices, "ground truth" is established through standardized laboratory tests and regulatory requirements (e.g., ASTM standards, CFR regulations).
The sample size for the training set: Not applicable. This is not an AI model.
How the ground truth for the training set was established: Not applicable. This is not an AI model.

Summary

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队99217/

XIV. SUMMARY OF SAFETY AND EFFECTIVENESS

Allegiance

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES

Manufacturer:	Allegiance Healthcare Sdn. Bhd.Plot 87, Kampung Jawa11900 Bayan LepasPenang, West Malaysia
Regulatory Affairs Contact: Erica Sethi	Allegiance Healthcare Corporation1500 Waukegan Road, MP-WMMcGaw Park, IL 60085
Telephone:	(847) 785-3337
Date Summary Prepared:	6/16/99
Product Trade Name:	Undetermined
Common Name:	Surgical Glove
Classification:	Glove, Surgeon's
Predicate Devices:	Ultrafree Sterile Latex Powder-Free Surgical Gloves
Description:	Coated Sterile Latex Powder-free Surgical gloves are formulatedusing natural rubber latex and are coated with a nitrile coating.These are offered powder-free and sterile.
Intended Use:	Coated Sterile Latex Powder-Free Surgical Gloves areintended for use in environments within hospitals and otherhealthcare facilities. The gloves are appropriate for use duringinvasive and non-invasive medical procedures requiring sterility.They are intended to be worn by operating room personnel toprotect a surgical wound from contamination.

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Substantial Equivalence:	Coated Sterile Latex Powder-Free Surgical Gloves are substantially equivalent to Ultrafree Sterile Latex Powder-Free Surgical Gloves in that they provide the following characteristics:- same intended use- same sizes, configuration, packaging- both made of natural rubber latex- same tensile strength and thickness profiles
Summary of Testing:
Test	Result
Systemic Toxicity	Gloves do not elicit any toxic reactions to acute application.
Intracutaneous Reactivity	Gloves show no reactivity.
Guinea Pig Maximization	Gloves do not display any potential for irritation.
Ultimate Elongation& Tensile Strength	Gloves meet or exceed requirements for rubber surgical gloves per ASTM D3577-99.
Barrier Defects	Gloves exceed requirements per 21 CFR§800.20, AQL = 2.5.
Data/Test Method	Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-97-Standard test method for residual powder on medical gloves. Results generated values below 4 mg of residual powder per glove.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the words "Public Health Service". The text is in a bold, sans-serif font. The words are arranged on a single line.

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SED 1 4 1999

Ms. Erica Sethi Manager, Regulatory Affairs Alleqiance Healthcare Corporation 1500 Waukeqan Road McGaw Park, Illinois 60085

Re : K992171 Coated Sterile Latex Powder-Free Surgical Trade Name: Gloves with Protein Content Labeling Claim (50 micrograms or less) Requlatory Class: · 4 · Product Code: KGO Dated: August 18, 1999 Received: August 19, 1999

Dear Ms. Sethi:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 -Ms. Sethi

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sia equivalence of your device to a legally marketed predicate device results in a classification for your marketed production of mits 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact che Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to che regulation chercica) Missions information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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Image /page/4/Picture/1 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a symbol that looks like a plus sign made up of small dots. The word is in black and the background is white. The font is slightly slanted to the right.

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:
Device Name:	Coated Sterile Latex Powder-Free Surgical GlovesWith Protein Content Labeling Claim (50 micrograms or less)
Indications For Use:	These gloves are intended for use in environments within hospitalsand other healthcare facilities. The gloves are appropriate for use duringinvasive as well as non-invasive medical procedures requiring sterility.They are intended to be worn by operating room personnel to protect asurgical wound from contamination.

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	Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)	or Over-The Counter Use ✓
	(Division Sign-Off)Division of Dental, Infection Control,and General Hospital Devices
510(k) Number	K992171

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).