Latex Examination Gloves, Powdered, Blue, Non-Sterile 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 Latex Examination Gloves, Powdered, Blue, Non Sterile meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Test.

AI/ML Overview

The provided document describes the acceptance criteria and performance of PT. WRP Buana Multicorpora's Latex Examination Gloves, Powdered, Blue, Non-Sterile.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

CHARACTERISTICS	STANDARDS (Acceptance Criteria)	DEVICE PERFORMANCE
Dimensions	D 3578 – 01ae2	Meets
Physical Properties	D 3578 - 01ae2	Meets
Freedom from Pinholes	D 3578 - 01ae2, FDA 21 CFR 800.20	Meets
Powder Amount	D 3578 - 01ae2, D 6124 - 01	< 10 mg/dm²
Water Soluble Protein Content	D 3578 – 01ae2, D 5712 - 99	< 200mg/dm²
Biocompatibility (Primary Skin Irritation)	Primary Skin Irritation in Rabbits	Passes (No primary skin irritation)
Biocompatibility (Dermal Sensitization)	Dermal Sensitization	Passes (No contact sensitizer)

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

The document does not specify the exact sample size used for each "test set" (batch of gloves tested to demonstrate compliance). However, it implies that the tests were conducted on batches of the device to ensure they "Meet" the specified standards.

Data Provenance: The tests were conducted by PT. WRP Buana Multicorpora, an Indonesian company. The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate compliance with existing standards.

3. 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. For device performance testing of physical/chemical characteristics and biocompatibility, specialized laboratory testing and interpretation by appropriately qualified lab personnel are typically involved, but "experts" in the sense of medical professionals adjudicating diagnostic results are not relevant here.

4. Adjudication method for the test set

This information is not applicable/provided as the tests relate to objective physical, chemical, and biological properties of the glove, which are likely evaluated against predefined thresholds in the ASTM standards. There is no mention of a subjective adjudication process by multiple individuals.

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 device is a physical product (examination gloves), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI-related comparative effectiveness is irrelevant to its evaluation.

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

Not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is based on defined standards set by ASTM (American Society for Testing and Materials) and FDA regulations. For example:

Physical properties and dimensions: Defined by ASTM D 3578 – 01ae2.
Freedom from pinholes: Defined by ASTM D 3578 - 01ae2 and FDA 21 CFR 800.20 (specifically, the 1000 ml Water Leak Test).
Powder amount and Water Soluble Protein Content: Defined by specific ASTM standards (D 6124 - 01 and D 5712 - 99, respectively).
Biocompatibility: Assessed using standard animal models (Primary Skin Irritation in Rabbits and Dermal Sensitization tests) with established criteria for "passes."

8. The sample size for the training set

Not applicable. This refers to a manufactured product and not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable. As above, there is no "training set" for this type of device. The ground truth for evaluating the device's compliance is established by the specified industry and regulatory standards.

Summary

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WRP Buana Multicorpora

K030273

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

MAR 2 6 2003

Tel	+62-61-6942461
	+62-61-6942462
Fax	+62-61-6942463

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 : January 21, 2003

2.0 Contact Person :

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

3.0 Name of the device :

Trade Name	1). Glovetex, and2). Multiple or Customers' Trade Name
Device Name	: Latex Examination Gloves, Powdered, Blue, Non-Sterile
Common Name	: Examination Gloves
Classification Name	: Patient Examination Gloves (Class I)

4.0 ldentification of The Legally Marketed Device :

Class I patient examination gloves, 80LYY, powdered, that meets all the requirements of ASTM standard D 3578 – 01a 2 and FDA 1000 ml Water Leak Test.

5.0 Description of The Device :

The Latex Examination Gloves, Powdered, Blue, Non Sterile meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Test.

6.0 Intended Use of the Device :

The Latex Examination Glove, Powdered, Blue, Non Sterile 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 a sequence of alphanumeric characters, specifically "KO30273". The characters are written in a bold, sans-serif font, and they appear to be handwritten. The image is in black and white, and the characters are clearly legible against the white background.

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

+62-61-6942461 Tel +62-61-6942462 +62-61-6942463 Fax

Summary of The Technological Characteristics of The Device : 7.0

RP Buana Multicorpora

The Latex Examination Gloves, Powdered, Blue, Non Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards.

CHARACTERISTICS	STANDARDS	DEVICEPERFORMANCE
Dimensions	D 3578 – 01ae2	Meets
Physical Properties	D 3578 - 01ae2	Meets
Freedom from Pinholes	D 3578 - 01ae2FDA 21 CFR 800.20	Meets
Powder Amount	D 3578 - 01ae2D 6124 - 01	< 10 mg/dm²
Water Soluble Protein Content	D 3578 – 01ae2D 5712 - 99	< 200mg/dm²
Biocompatability	Primary Skin Irritation in Rabbits	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.

Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0

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 Latex Examination Gloves, Powdered, Blue, Non Sterile 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 wing-like shapes, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2003

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

Re: K030273

Trade/Device Name: Latex Examination Gloves, Powdered, Blue, Non-Sterile Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: January 22, 2003 Received: January 27, 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,

Susan Runner

Susan Runner, DDS, 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 a logo with the letters "WRP" in white, set against a black, rounded rectangle. The letters are bold and slightly distorted, giving them a textured appearance. The overall design is simple and eye-catching, with a clear contrast between the text and the background.

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

Tel +62-61-6942461 +62-61-6942462 +62-61-6942463 Fax

INDICATIONS FOR USE

: PT. WRP Buana Multicorpora Applicant K030273 510(k) Number (if known) : _ : LATEX EXAMINATION GLOVES, Device Name POWDERED, BLUE, NON STERILE

Indications For Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chin S. Lin

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

510(k) Number: K030273

Prescription Use (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.