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

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

The provided text describes the acceptance criteria and test results for "Powder-Free Latex Examination Gloves with Protein & Chemotherapy Labeling Claim."

Here's a breakdown of the requested information based on the document:

1. A table of acceptance criteria and the reported device performance

Test	Acceptance Criteria	Reported Device Performance
Primary Skin Irritation	(Implicit: Does not display irritation potential)	Glove does not display irritation potential.
Sensitization Potential (Guinea Pig Max)	(Implicit: Does not display sensitization potential)	Glove does not display sensitization potential.
Ultimate Elongation & Tensile Strength	Meets or exceeds requirements per ASTM D3578-00.	Glove meets or exceeds requirements for rubber examination gloves per ASTM D3578-00.
Barrier Defects	Meets or exceeds requirements per 21 CFR §800.20 and ASTM D3578-00, AQL=2.5.	Glove meets or exceeds requirements per 21 CFR §800.20 and ASTM D3578-00, AQL=2.5.
Powder Level	Meets requirements for "Powder Free" designation per ASTM D 3578-00.	Glove meets powder level requirements for "Powder Free" designation per ASTM D 3578-00.
Protein Labeling Claim	50 microgram or less of total water extractable protein per gram of glove per ASTM 5712-95.	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 Permeation (Intended Use)	Tested for use with chemotherapy drugs using ASTM F 739-99a.	These gloves have been tested for use with chemotherapy drugs using ASTM F 739-99a. (Note: The document states that it was tested but does not explicitly provide a pass/fail criteria or specific permeation results in the summary of test results section).

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

The document does not explicitly state the sample sizes used for each test or the data provenance (e.g., country of origin, retrospective/prospective). It refers to specific ASTM standards (D3578-00, 5712-95, F 739-99a) and 21 CFR §800.20, which would typically define the sampling plans. The manufacturer is Allegiance Healthcare Sdn. Bhd. located in Penang, West Malaysia, suggesting the data may originate from Malaysia or internal corporate testing.

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)

This section is not applicable to this device. The tests described are laboratory performance tests for physical properties and chemical composition of gloves, not diagnostic tests requiring expert interpretation for ground truth. The "ground truth" here is objective measurement against established standards.

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

This section is not applicable to this device, as adjudication is typically relevant for subjective expert assessments, which are not involved in these performance tests. The evaluation is based on meeting predefined objective standards.

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

This section is not applicable to this device. This is a medical device (patient examination gloves), not an AI-assisted diagnostic tool. Therefore, MRMC studies or AI involvement are irrelevant.

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

This section is not applicable to this device. As mentioned, this is not an algorithm or AI-based device.

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

The "ground truth" for this device's performance tests is based on objective measurement against established industry standards and regulations. These include:

ASTM D3578-00 (Standard Specification for Rubber Examination Gloves)
21 CFR §800.20 (Barriers)
ASTM 5712-95 (Standard Test Method for the Total Protein in Natural Rubber Latex and its Concentrates by the Lowry Method)
ASTM F 739-99a (Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact)

8. The sample size for the training set

This section is not applicable to this device. There is no concept of a "training set" for physical test results of examination gloves. The manufacturing process and quality control would involve ongoing testing, but not in the sense of a training set for an AI model.

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

This section is not applicable to this device for the same reasons as (8).

Summary

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SEP 2 4 2001

Image /page/0/Picture/1 description: The image shows the word "Allegiance" in a stylized font. The word is written in black and appears to be slightly italicized. There is a symbol to the left of the word that looks like a plus sign made up of small circles.

STATEMENT OF SAFETY AND EFFECTIVENESS XIII.

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

Manufacturer:

Allegiance Healthcare Sdn. Bhd. Plot 87 Kampung Jawa Bayan Lepas Penang, West Malaysia 11900

Regulatory Affairs Contact:

Erica Sethi 1500 Waukegan Road, Bldg. WM McGaw Park, IL 60085

Telephone:

(847) 785-3337

June 21, 2001

Date Summary Prepared:

Common Name:

Classification:

Predicate Devices:

Description:

Intended Use:

Patient Examination Glove

Glove, Examination (Latex)

Positive Touch Powder-Free Latex Examination Gloves With Protein and Chemotherapy Labeling Claim

10/214

Powder-Free Latex Examination Gloves With Protein and Chemotherapy Labeling Claim are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs using ASTM F 739-99a.

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Image /page/1/Picture/0 description: The image contains 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 squares. The word "Allegiance" is written in a dark color, possibly black or a dark shade of gray. The font appears to be bold and slightly italicized.

STATEMENT OF SAFETY AND EFFECTIVENESS XIII.

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

Substantial Equivalence

Powder Free Examination Gloves With Protein and Chemotherapy Labeling Claim are substantially equivalent to Positive Touch Powder-Free Latex Examination Gloves in that they provide the following characteristics:

intended use
size, design, product features
made of natural rubber latex
physical characteristics

Summary of Test Results:

Test

Result

Glove does not display irritation potential.

Glove does not display sensitization potential. Guinea Pig Maximization

Ultimate Elongation & Tensile Strength

Primary Skin Irritation

Barrier Defects

Powder Level

Protein Labeling Claim

Glove meets or exceeds requirements for rubber examination gloves per ASTM D3578-00.

Glove meets or exceeds requirements per 21 CFR $800.20 and ASTM D3578-00, AQL=2.5.

Glove meets powder level requirements for "Powder Free" designation per ASTM D 3578-00.

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).

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2001

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

Re: K012149

Trade/Device Name: Powder-Free Latex Examination Gloves with Protein, Chemotherapy Labeling Claim Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: June 21, 2001 Received: July 10, 2001

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 (section 531-542 of the Act; 21); CFR 1000-1050.

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) 594-4618. 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 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.

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/0 description: The image shows the word "Allegiance" in a bold, italicized font. To the left of the word is a symbol that resembles a plus sign, but it is made up of many small dots. The word is in black, and the background is white.

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:	K012149
Device Name:	Powder-Free Latex Examination Gloves With Protein, Chemotherapy 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. 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __________(Per 21 CFR 801.109)	or	Over-The Counter Use __________
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Signature
(Division Sign-Off) (Division Sign-Un)
Division of Dental, Infection Control,
Division of Dental, Devices Division of Dollars and General Hospital V 015 510(k) Number ------

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.