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.

Device Description

The Powder Free Non Sterile Examination gloves with a protein label claim are formulated using in-house compounded latex and offered non-sterile.

AI/ML Overview

This document describes the safety and effectiveness of the Allegiance Non-Sterile Powder-Free Latex Examination Glove With Protein Labeling Claim.

Acceptance Criteria and Reported Device Performance:

The device's performance is primarily evaluated against the ASTM Standard Specification for Rubber Examination Gloves D3578-95 and FDA regulations (21 CFR §800.20 and 21 CFR 807.97).

Acceptance Criteria / Test	Reported Device Performance
Biocompatibility
Primary Skin Irritation (ISO 10993-1 / USP XXIII)	Acceptable criterion for primary skin irritation. (Passed)
Intracutaneous Reactivity (ISO 10993-1 / USP XXIII)	Glove does not elicit irritation following intradermal injection of extracts.
Skin Sensitization (Kligman Maximization method)	Glove does not display sensitization potential to produce skin sensitization.
Physical Characteristics (ASTM D3578-95)
Ultimate Elongation & Tensile Strength	Glove meets or exceeds requirements for rubber examination gloves per ASTM D3578-95.
Barrier Defects (using FDA 1000 mL test method, 21 CFR §800.20)	Glove meets or exceeds requirements per 21 CFR §800.20 and ASTM D3578-95, AQL=4.0.
Protein Label Claim (ASTM 5712-95)
Low protein claim designation (50 mcg or less total water extractable protein per gram per glove)	Gloves meet requirements for a low protein claim designation of 50 micrograms or less of total water extractable protein per gram per glove using the ASTM Lowry test method (ASTM 5712-95).
Powder-Free Designation
Powder level (below 2mg/glove cornstarch using vacuum filtration method + negative iodine test)	Gloves meet powder level requirements for "Powder Free" designation using the vacuum filtration method plus a negative iodine test. Results generated values below the 2mg/glove cornstarch.
Dimensions (Medium Glove)
Length (min. cm)	min. 23.0
Width (cm)	9.8-10.0 (reported); ASTM D3578-95 value not specified for comparison
Thickness: Cuff (min. mm)	0.13 mm (min.)
Thickness: Palm (min. mm)	0.19 mm (min.)
Thickness: Finger (min. mm)	0.20 mm (min.)

Study Details:

Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for barrier defects, number of subjects for skin irritation tests).
- The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). The manufacturing and chlorination facilities are located in Malaysia, suggesting tests might have been conducted there or on products from those facilities.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document as it pertains to medical device testing against established standards (ASTM, ISO, FDA regulations), rather than diagnostic algorithm evaluation requiring expert consensus on images/data. The "ground truth" is defined by the objective measurement techniques and criteria outlined in the referenced standards.
Adjudication method for the test set:
- Not applicable in this context. The evaluation is based on objective measurements against predefined thresholds in established standards.
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 (examination glove), not an AI-based diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used:
- The ground truth is based on established industry standards and regulatory requirements, including:
  - ASTM Standard Specification for Rubber Examination Gloves D3578-95
  - ISO 10993-1 / USP XXIII (for biocompatibility)
  - 21 CFR §800.20 (FDA 1000 mL leak test method)
  - ASTM 5712-95 (for protein level determination)
The sample size for the training set:
- Not applicable. This device does not involve machine learning or a training set in the conventional sense.
How the ground truth for the training set was established:
- Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its head and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Maryalice Smith Regulatory Affairs Manager JUL 28 1997 Allegiance Healthcare Corporation 1500 Waukeqan Road #K McGraw Park, Illinois 60085

K972291 Re : Trade Name: Alleqiance Non Sterile Powder Free Latex Examination Glove With Protein Labeling Claim Requlatory Class: I Product Code: LYY Dated: May 28, 1997 Received: June 19, 1997

Dear Ms. Smith:

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 registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) 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 obligation you might have under sections 531 \

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Page 2 - Ms. Smith

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 requlation (21 CFR Part 801 and additionally 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 one regarders fication" (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,

Patriccia Guerite/for

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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NO.306 6.9/18

JUL.14.1997" 9:55AM

Image /page/2/Picture/2 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 squares. The word is in black and the background is white.

Allegiance Healthcare Corporation 1500 Waukagan Road McGaw Park, Illinols 60085-6787
847.473.1600 FAX: 847.785.2460

Page 1 of 1

Applicant:	Allegiance Healthcare Corporation
510(k) Number (if known)	K972291
Device Name:	Non Sterile Powder-Free Latex Examination Gloves with a Protein Label 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.

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

(Division Sign-Off
Division of Dental, Infection Control, and General Hospital Devices	Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number	4972291
Prescription Use(Per 21 CFR 801.109)	cr
	Over-The Counter Uss

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JUL 28 1997

K972291 XIII.510(k) SUMMARY Allegiance Healthcare Corporation Applicant: 1500 Waukegan Road, Bldg. K McGaw Park, IL 60085 Contact Person: Maryalice Smith, (847) 785-3322 2. Manufacturing and Allegiance Healthcare Sdn. Bhd. Chlorination Facility: Plot 87 Kampung Jawa Bayan Lepas, Penang, West Malaysia 11900 Digitcare Corporation Sdn. Bhd. 3. Chlorination Facility: Lot 3 Jalan 1/113A, Batu 4 1/2, Jalan Kelang Lama, Kilang Yee Seng, 58000 Kuala Lumpur, Malaysia Maxi Support Sdn. Bhd. 99-L Lorong Perak 4, Kawasan Perusahaan Mergong. 05150 Alor Setar, Kedah Darul Aman, Malaysia.

1. The Powder-Free Non-Sterile Latex Examination Gloves, with a protein label claim, are substantially equivalent to the Flexam Powdered Non-Sterile Examination Glove in regard to the material, design, physical characteristics and intended use.
  A battery of performance tests were conducted, verifying the acceptability of this product for its intended use. The Powder-Free Non-Sterile Latex Examination Gloves with a protein label claim were subjected to biological evaluation. The gloves passed the acceptability criteria for primary skin irritation, intracutaneous reactivity and skin sensitization as outlined in ISO 10993 1/USP XXIII. In addition, the product was found acceptable based on chemical analysis of materials. Test methods for inspection of gloves and for chemical, biocompatibility and physical testing are listed in Appendix C of this document. The leak test method employed is the FDA 1000 mL test method which is described in 21 CFR §800.20.

This product meets the requirement specified in ASTM Standard Specification for Rubber Examiniation Gloves D3578-95.

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XIII. 510(k) SUMMARY (Con't)

7. Physical Characteristics:

See Appendix C, Page 37 for detailed summary

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This product will be marketed non-sterile in sizes small, medium, large and 8. extra large.. Dimensions of the medium glove is as follows:

Size: Medium
Length (cm)	min. 23.0	min. 23.0
Width (cm)	9.8-10.0	8.5-10.5
Thickness (cm)
Cuff	0.13 mm(min.)	NA
Palm	0.19 mm(min.)	0.08 mm (min.)
Finger	0.20 mm(min.)	0.08 mm (min.)

1. Powder manufactured by Roquette America, Inc., Keokuk, Iowa 52632, (NDA 85-356) is used during manufacture. Powders which may be present due to the manufacturing process are removed through chlorination. The Quality Assurance method is included in Appendix E. No special claims are made for this product and the product is not expiration dated.

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Image /page/5/Picture/2 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a symbol that resembles a plus sign made up of small squares. The word "Allegiance" is written in all caps and is slightly slanted to the right.

XIV. STATEMENT OF SAFETY AND EFFECTIVENESS

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVESWITH A PROTEIN LABEL CLAIM

Manufacturer:	Allegiance Healthcare Sdn. Bhd.Plot 87 Kampung JawaBayan LepasPenang, West Malaysia 11900
Regulatory Affairs Contact:	Maryalice Smith1500 Waukegan Road, Bldg. KMcGaw Park, IL 60085
Telephone:	(847) 785-3322
Date Summary Prepared:	May, 1997
Product Trade Name:	Powder-Free Non-Sterile Latex Examination Gloves with aProtein Label Claim
Common Name:	Patient Examination Glove
Classification:	Glove, Examination (Latex)
Predicate Devices:	Flexam Examination Gloves (latex).
Description:	The Powder Free Non Sterile Examination gloves with aprotein label claim are formulated using in-housecompounded latex and offered non-sterile.
Intended Use:	Powder-Free Non-Sterile Latex Examination gloves with aprotein label claim. Gloves are a disposable deviceintended for medical purposes that are worn on theexaminer's hand or finger to prevent contaminationbetween patient and examiner.

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Image /page/6/Picture/2 description: The image shows the word "Allegiance" in a stylized, bold, black font. To the left of the word is a graphic of a cluster of small squares arranged in a pattern that resembles a starburst or a stylized flower. The word "Allegiance" is written in a slightly italicized font, giving it a sense of movement or dynamism.

XIV. STATEMENT OF SAFETY AND EFFECTIVENESS

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (con't) POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVES WITH A PROTEIN LABEL CLAIM

Substantial Equivalence	Powder Free Non-Sterile Examination Gloves with aprotein label claim are substantially equivalent to theFlexam Non-Sterile Examination Gloves in that theyprovide the following characteristics:- intended use- size, configuration, packaging- made of natural rubber latex- tensile strength and thickness profiles
Summary of Testing:	Test	Result
	Intracutaneous Reactivity	Glove does not elicitirritation followingintradermal injection ofextracts.
	Kligman Maximization	Glove does not displaysensitization potential toproduce skin sensitization
	Ultimate Elongation& Tensile Strength	Glove meets or exceedsrequirements for rubber

Barrier Defects

examination gloves per ASTM D3578-95.

Glove meets or exceeds requirements per 21 CFR

ASTM D3578-95, AQL=4.0.

§800.20 and

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Image /page/7/Picture/2 description: The image contains the word "Allegiance" in a stylized, bold, black font. To the left of the word is a graphic that resembles a plus sign made up of small squares. The word is slightly slanted upwards from left to right, giving it a dynamic appearance. The overall design is simple yet impactful, with the focus on the brand name.

XIV. STATEMENT OF SAFETY AND EFFECTIVENESS

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (con't) POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVES WOTH A PROTEIN LABEL CLAIM

Summary of Testing:

Test

Data/Test Method

Gloves meet powder level requirements for "Powder Free" designation using the vacuum filtration method plus a negative iodine test. Results generated values below the 2mg/glove cornstarch.

Result

Gloves meet requirements for a low protein claim designation of 50 microgram or less of total water extractable protein per gram per glove using the ASTM Lowry test method (ASTM 5712-95).

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.