Powder Free Latex Examination Gloves, Blue, Non-Sterile (Contains 50 micrograms or less of Water Extractable Protein per gram) 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

The Powder Free Latex Examination Gloves, Blue, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Test.

AI/ML Overview

The provided text describes the acceptance criteria and performance of Powder Free Latex Examination Gloves. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
Dimensions	D 3578 - 01aᵉ²	Meets
Physical Properties	D 3578 - 01aᵉ²	Meets
Freedom from Pinholes	D 3578 - 01aᵉ²FDA 21 CFR 800.20	Meets
Powder Residue	D 3578 - 01aᵉ²D 6124 - 01	< 2 mg/glove
Water Soluble Protein Content	D 3578 - 01aᵉ²D 5712 - 99	< 50 µg/g
Biocompatibility (Primary Skin Irritation in Rabbits)	-	Passes (No primary skin irritation)
Biocompatibility (Dermal Sensitization)	-	Passes (No contact sensitizer)

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated. The document refers to meeting standards such as ASTM D 3578 - 01aᵉ² and FDA 1000 ml Water Leak Test, which would imply specific sampling plans as defined within those standards, but the exact number of gloves tested is not provided in this summary.
Data Provenance: The testing was conducted by PT. WRP Buana Multicorpora, an Indonesian company. The data is retrospective in the sense that it's a summary of tests performed to demonstrate compliance with existing standards for a 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This type of information is not applicable to the evaluation of examination gloves. The "ground truth" for glove performance refers to meeting established physical, chemical, and biological standards (e.g., tensile strength, protein content, freedom from pinholes, biocompatibility). These are measured objectively by laboratory methods against defined criteria, not through expert consensus or interpretation.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or evaluations where subjective assessments (e.g., image interpretation) require consensus among multiple experts. Glove testing involves objective measurements against predetermined 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:

Not applicable. This is not an AI-enabled device or a diagnostic imaging device requiring human reader interpretation.

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

Not applicable. This is a physical medical device (examination gloves), not a software algorithm.

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

The "ground truth" for the device's performance is based on objective measurements against established national and international standards. These include:
- ASTM D 3578 - 01aᵉ² (Standard Specification for Rubber Examination Gloves) for dimensions, physical properties, and freedom from pinholes.
- FDA 21 CFR 800.20 (Barriers with an Integral Safety Shield or Feature) and the 1000 ml Water Leak Test for freedom from pinholes.
- ASTM D 6124 - 01 (Standard Test Method for Residual Powder on Medical Gloves) for powder residue.
- ASTM D 5712 - 99 (Standard Test Method for Analysis of Aqueous Extractable Protein in Latex and Natural Rubber) for water soluble protein content.
- Biocompatibility tests (Primary Skin Irritation in Rabbits, Dermal Sensitization), which involve standardized animal models or in-vitro tests with defined pass/fail criteria.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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JUL 2 8 2003

Image /page/0/Picture/1 description: The image shows a logo with the letters "WRP" in white against a black background. The letters are bold and slightly stylized, with the "W" and "R" connected at the top. To the right of the logo, there is a partial letter "P" in black, suggesting that there may be more text or another element that is cut off in the image.

P Buana Multicorpora

KO3 2007

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

510 (K) SUMMARY

1.0 Submitter :

Name	: PT. WRP Buana Multicorpora
Address	: Jl. Jermal No.20B Kelurahan Sei MatiMedan Labuhan KM 17, INDONESIA
Phone No.	: +61 6942461, 6942462
Fax No.	: +61 6942463

Date of Summary Prepared : June 9 , 2003

2.0 Contact Person :

Name	:Mr. Ng Poy Sin
Phone No.	:+61 6942461, 6942462
Fax No.	:+61 6942463

Name of the device : 3.0

Trade Name	1). Glovetex, and2). Multiple or Customers' Trade Name
Device Name	Powder Free Latex Examination Gloves, Blue, Non-SterileContains 50 micrograms or less of Total Water Extractable Protein per gram
Common Name	Examination Gloves
Classification Name	Patient Examination Gloves (Class I)

Identification of The Legally Marketed Device : 4.0

Class I patient examination gloves, 80LYY, powder free, that meets all the requirements of ASTM standard D 3578 -- 01a22 and FDA 1000 ml Water Leak Test.

5.0 Description of The Device :

6.0 Intended Use of the Device :

The Powder Free Latex Examination Gloves, Blue, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) is a disposable device intended for medical purposes that is worn on the examiner's hand 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 a stylized, bold font, enclosed in a black shape. 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 Fax +62-61-6942463 URL www.wrpworld.com

7.0 Summary of The Technological Characteristics of The Device :

The Powder Free Latex Examination Gloves, Blue, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
Dimensions	D 3578 - 01aᵉ²	Meets
Physical Properties	D 3578 - 01aᵉ²	Meets
Freedom from Pinholes	D 3578 - 01aᵉ²FDA 21 CFR 800.20	Meets
Powder Residue	D 3578 - 01aᵉ²D 6124 - 01	< 2 mg/glove
Water Soluble ProteinContent	D 3578 - 01aᵉ²D 5712 - 99	< 50 µg/g
Biocompatability	Primary Skin Irritation inRabbits	Passes(No primary skin irritation)
	Dermal Sensitization	Passes(No contact sensitizer)

8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data

The performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.

9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

10.0 Conclusion

It can be concluded that the Powder Free Latex Examination Gloves, Blue, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) will perform according to the glove performance standards referenced in Section (7) above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.

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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 features a stylized eagle with three heads facing to the right. The eagle is black and is surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2003

Ng Poy Sin President Director PT. WRP Buana Multicorpora Jalan Jermal #20-B, Kelurahan, Sei Mati, Madan- Labuhan Km 17, INDONESIA

Re: K032007

Trade/Device Name: Glovetex Powder Free Latex Examination Gloves Blue, Non-Sterile Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: June 12, 2003 Received: June 30, 2003

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 (QS) 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Paltace Cuerite/ba

Susan Runner, DDDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental 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 logo for PT. WRP Buana Multicorpora. The logo consists of the letters "WRP" in a stylized font inside of a black oval shape. 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 Tel +62-61-6942462 Fax +62-61-6942463 URL www.wrpworld.com

INDICATIONS FOR USE

Applicant	: PT. WRP Buana Multicorpora
510(k) Number (if known)	: K032002
Device Name	: POWDER FREE LATEX EXAMINATION GLOVES,BLUE, NON STERILE. (Contains 50 micrograms or

Indications For Use:

less of Total Water Extractable Protein per gram)

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

510(k) Number: K032007

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (Per 21 CFR 801.109)

Over-The-Counter _

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.