The Powder Free Latex Examination Gloves, Non-Sterile (Protein Content Labeling 50 µg/g or less) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Powder Free Latex Examination Gloves, Non Sterile (Protein Content Labeling 50 ug/q or less) is Class I Device, Code No. 80LYY. These gloves are made of natural rubber latex. Based on the protein content test result obtained the aloves are well bellow 50 ug/g and support our protein content labeling claim.

AI/ML Overview

The provided text describes a 510(k) summary for "Glovetex Powder Free Latex Examination Gloves, Non Sterile (Protein Content Labeling Claim 50ug/g or less)". This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study on a new device's performance against detailed acceptance criteria for an AI/algorithm.

The "acceptance criteria" and "device performance" in this context refer to the physical and chemical properties of the gloves themselves, compared against established standards for examination gloves and the specific protein content claim. The "study" described is the testing conducted on the gloves to demonstrate conformance to these standards and the protein content claim.

Here's an attempt to structure the information based on the provided request, interpreting "acceptance criteria" and "device performance" in the context of this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Claim)	Reported Device Performance
Material	Natural Rubber Latex
Sterility	Non-Sterile
Protein Content Labeling Claim (Total Water Extractable Protein)	50 µg/g or less (stated to be "well below 50 ug/g" based on test results)
Compliance with ASTM D 3578 (Standard Specification for Rubber Examination Gloves)	Meets
Compliance with FDA 1000ml Water Leak Test	Meets
Intended Use (Prevention of contamination between patient and examiner)	Meets (As per intended use statement)

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size used for each specific test (e.g., protein content, ASTM D 3578, water leak test). It generally states that "The result of the performance testing... are detailed in this submission."

Sample Size: Not explicitly stated for the test set of gloves.
Data Provenance: The manufacturing company is PT. WRP Buana Multicorpora, located in Indonesia. The testing would have been conducted by or for this manufacturer. The document doesn't specify if the data is retrospective or prospective, but performance testing for a 510(k) submission typically involves prospective testing of production samples.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This type of information (number of experts, their qualifications, and ground truth establishment) is typically relevant for studies involving human interpretation (e.g., image analysis, clinical diagnosis). For the physical and chemical testing of examination gloves, "ground truth" is established by laboratory measurements and adherence to specified testing protocols (e.g., ASTM standards). Therefore, this question is not directly applicable in the conventional sense to this device. The "experts" would be qualified laboratory technicians or engineers performing the tests.

4. Adjudication Method for the Test Set

Again, adjudication methods like 2+1 or 3+1 are primarily used for reaching consensus among multiple human reviewers/experts, particularly in studies involving subjective interpretation. For objective laboratory tests on gloves, adjudication is not typically performed in this manner. The results are based on direct measurement and comparison to predefined thresholds.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic or interpretive devices (e.g., AI in radiology) where human readers are involved. This submission is for physical examination gloves.

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

No, this pertains to a physical medical device (examination gloves), not an algorithm or AI. Therefore, a standalone performance study in the context of "algorithm only" is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims of these gloves is based on:

Laboratory Testing Results: Direct measurements of physical properties (e.g., water leak test) and chemical properties (e.g., protein content determination).
Adherence to Established Standards: Conformance to recognized industry standards such as ASTM D 3578.

8. The Sample Size for the Training Set

This question is not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for PT. WRP Buana Multicorpora. The logo consists of the letters WRP in a stylized font, with the letters overlapping each other. The letters are white and are set against a black background. To the right of the logo is the text "PT. WRP Buana Multicorpora" in a bold, sans-serif font.

Jalan Jermal No. 20-B, Kelurahan Sei Mati, Medan-Labuhan Km 17, INDONESIA

62-61-6942461 62-61-6942462 62-61-6942463 www.wroworld.com

SEP 1 6 2002

K022343

510 (K) SUMMARY OF POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (Protein Content Labeling Claim 50ug/g or less)

Glovetex Powder Free Latex Examination Gloves, 1. Trade Name : Non Sterile (Protein Content Labeling Claim 50 ug/g or less).
1. Device Name : Powder Free Latex Examination Gloves, Non Sterile (Protein Content Labeling Claim 50 ug/g or less).
1. Device Listing No. : A 907707
1. Description of the Device :

Powder Free Latex Examination Gloves, Non Sterile (Protein Content Labeling Claim 50 ug/q or less) is Class I Device, Code No. 80LYY. These gloves are made of natural rubber latex. Based on the protein content test result obtained the aloves are well bellow 50 ug/g and support our protein content labeling claim.

The result of the performance testing of Powder Free Latex Examination Gloves, Non Sterile (Protein Content Labeling Claim 50ug/g or less) are detailed in this submission and are summarized as in the attachment-1.

1. Equivalency :
  Powder Free Latex Examination Gloves, Non Sterile (Protein Content Labeling Claim 50 µg/g or less) are substantially equivalent to Powder Free Latex Examination Gloves, Non-Sterile submitted and cleared under 510(k) number K970115. The only difference in this submission is to include the protein content labeling claim 50μg/q or less with no changes in product design.
1. Intended Use :
  These gloves are intended to be worn on examiner's hand or finger to prevent contamination between patient and examiner.

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Image /page/1/Picture/0 description: The image shows the logo for PT. WRP Buana Multicorpora. The logo consists of the letters "WRP" in white, inside of a black hexagon. To the right of the logo is the text "PT. WRP Buana Multicorpora" in black.

Jalan Jermal
No. 20-B, Kelurahan Sei Mati,
Medan-Labuhan Km 17,
INDONESIA

Tel	+62-61-6942461
	+62-61-6942462
Fax	+62-61-6942463
URL	www.wrpworld.com

Comparison with a Predicate Devices

Characteristics	Powder Free LatexExamination Gloves, NonSterile.	Powder Free LatexExamination Gloves, NonSterile with ProteinContent labeling Claim
Product Code	80LYY	80LYY
510 (K) Number	K970115	-
Comply with ASTM D 3578	Meets	Meets
Materials	Natural Rubber Latex	Natural Rubber Latex
Intended Use	To be worn on theexaminer's hand or finger toprevent contaminationbetween patient andexaminer	To be worn on theexaminer's hand or finger toprevent contaminationbetween patient andexaminer
Comply with FDA 1000mlWater Leak Test	Meets	Meets
Protein Content labelingClaim (50ug/g or less)	N/A	Meets

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2002

Mr. Ng Poy Sin President Director PT. WRP Buana Multicorpora Jalan Jermal No. 20-B. Kelurahan, Sei Mati Medan-Labuhan Km 17, INDONESIA

Re: K022343

Trade/Device Name: Glovetex Powder Free Latex Examination Gloves, Non-Sterile Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: August 26, 2002 Received: August 30,2002

Dear Mr. Sin:

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.

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Page 2 – Mr. Sin

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 (OS) 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 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 21 CFR Part 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 Part 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

. Susan Runser

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

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Image /page/4/Picture/0 description: The image shows the logo for PT. WRP Buana Multicorpora. On the left is a circular logo with the letters WRP in it. To the right of the logo is the text "PT. WRP Buana Multicorpora" in a bold, sans-serif font.

Jalan Jermal No. 20-B. Kelurahan Sei Mati. Medan-Labuhan Km 17, INDONESIA

Tel + 62-61-6942461 +62-61-6942462 +62-61-6942463 Fax URL www.wrpworld.com

INDICATIONS FOR USE

Applicant : PT. WRP Buana Multicorpora

510(k) Number (if known)

Device Name

: POWDER FREE LATEX EXAMINATION GLOVES NON STERILE (Protein Content labeling Claim 50 ug/g or less) Contains 50 mcgm on less of Total ou profess, Frofern per gram

Indications For Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Over-The-Counter ___________ OR (Per 21 CFR 801.109)

Shanti ter din
Fatin S. 08

(Division Sign-Om)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

Page 1 of 1

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.