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

Ultraderm Surgical gloves are formulated using natural rubber latex and contain 50 micrograms or less of total water extractable protein per gram

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Ultraderm Sterile Latex Surgical Gloves with Protein Content Labeling Claim, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Primary Skin Irritation	No potential for irritation	Biocompatibility tests were successfully performed on Ultraderm Surgical Gloves with Protein Content Labeling Claim. Gloves do not display any potential for irritation.
Systemic Toxicity	No toxic reactions to acute application	Gloves do not elicit any toxic reactions to acute application.
Intracutaneous Reactivity	No reactivity	Gloves show no reactivity.
Hemocompatibility	No lysis	Gloves are hemocompatible exhibiting no lysis.
Guinea Pig Maximization	No 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 D3577-98	Gloves meet or exceed requirements for rubber surgical gloves per ASTM D3577-98.
Barrier Defects	Meet or exceed requirements per 21 CFR §800.20, AQL = 2.5	Gloves meet or exceed requirements per 21 CFR §800.20, AQL = 2.5.
Protein Content Labeling Claim	50 micrograms or less of total water extractable protein per gram	Gloves meet requirements for protein claim of 50 micrograms or less of water extractable protein per gram.

Missing Information (Not Available in the Provided Text):

The provided text does not contain information regarding the following aspects, as it pertains to a medical device and not an AI/software-based device performance study:

Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The sample size for the training set
How the ground truth for the training set was established

This is expected as the document describes the substantial equivalence of a physical medical device (surgical gloves) and not a software algorithm or AI-powered system, which would typically involve such detailed study designs. The "studies" described are biocompatibility and physical property tests for the gloves themselves.

Summary

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XIV. SUMMARY OF SAFETY AND EFFECTIVENESS

Allegiance

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ULTRADERM STERILE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM

Manufacturer:	Allegiance Healthcare Sdn. Bhd.Plot 87, Kampung Jawa11900 Bayan LepasPenang, West Malaysia
Regulatory Affairs Contact:	Erica SethiAllegiance Healthcare Corporation1500 Waukegan Road, MP-WMMcGaw Park, IL 60085
Telephone:	(847) 785-3337
Date Summary Prepared:	3/26/99
Product Trade Name:	Ultraderm Sterile Latex Surgical Gloves with Protein ContentLabeling Claim
Common Name:	Surgical Glove
Classification:	Glove, Surgeon's
Predicate Devices:	Ultraderm Sterile Latex Surgical Gloves
Description:	Ultraderm Surgical gloves are formulated using natural rubber latexand contain 50 micrograms or less of total water extractable proteinper gram
Intended Use:	Ultraderm Sterile Latex Surgical Gloves with Protein ContentLabeling Claim are intended for use in environments within hospitalsand other healthcare facilities. The gloves are appropriate for useduring invasive and non-invasive medical procedures requiring sterilityThey are intended to be worn by operating room personnel toprotect a surgical wound from contamination.

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K991205

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Substantial Equivalence:	Ultraderm Sterile Latex Surgical Gloves with Protein ContentLabeling Claim are substantially equivalent to Ultraderm Sterile LatexSurgical Gloves in that they provide the following characteristics:- same intended use- same sizes, configuration, packaging- both made of natural rubber latex using same formulationand manufacturing process- same tensile strength and thickness profiles
Summary of Testing:
Test	Result
Primary SkinIrritation	Biocompatability tests were successfully performed onUltraderm Surgical Gloves with Protein Content Labeling Claim.Gloves do not display any potential for irritation.
Systemic Toxicity	Gloves do not elicit any toxic reactions to acute application.
Intracutaneous Reactivity	Gloves show no reactivity.
Hemocompatibility	Gloves are hemocompatible exhibiting no lysis.
Guinea Pig Maximization	Gloves do not display any potential for irritation.
Ultimate Elongation& Tensile Strength	Gloves meet or exceed requirements for rubber surgical glovesper ASTM D3577-98.
Barrier Defects	Gloves meet or exceed requirements per 21 CFR§800.20, AQL = 2.5.
Data/Test Method	Gloves meet requirements for protein claim of 50 micrograms or lessof water extractable protein per gram using ASTM Lowry test method

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 3 1999

Ms. Erica Sethi Manager, Requlatory Affairs Alleqiance Healthcare Corporation 1500 Waukegan Road McGraw Park, IL 60085

Re : K991205

Trade Name: Ultraderm Sterile Latex Powdered Surqical Gloves With Protein Content Labeling Claim (50 micrograms or less) Regulatory Class: I Product Code: KGO Dated: Auqust 5, 1999 Received: Auqust 9, 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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (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) regulation (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 regulation 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

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Page 2 - Ms. Sethi

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general 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,

Susa Runnon

Timothy 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 stylized font. To the left of the word is a symbol that resembles a plus sign made up of small dots. The word "Allegiance" is written in a bold, italicized font, with the "A" being larger than the other letters. The overall impression is that of a logo or brand name.

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

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Applicant:	Allegiance Healthcare Corporation
510(k) Number:	K991205
Device Name:	Ultraderm Sterile Latex Surgical Gloves with Protein Content Labeling Claim (50 micrograms or less)
Indications For Use:	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.

(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 X

Olin S. Lim

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number

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).