Powder Free White Nitrile Examination Gloves, Non-Sterile is a disposable device and made of Synthetic Rubber 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 White Nitrile Examination Gloves, Non sterile meets all the requirements of ASTM standard D 6319 – 00a83 and FDA 1000 ml Water Leak Test.

AI/ML Overview

This document describes the acceptance criteria and performance of Powder Free White Nitrile Examination Gloves, Non-Sterile.

Table of Acceptance Criteria and Reported Device Performance:

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
Dimensions	D 6319 – 00ae3	Meets
Physical Properties	D 6319 - 00ae3	Meets
Freedom from Pinholes	D 6319 - 00ae3, FDA 21 CFR 800.20	Meets
Powder Free Residue	D 6124 - 01	Meets (< 2 mg/glove)
Biocompatibility (Primary Skin Irritation)	Primary Skin Irritation in Rabbits	Passes (No primary skin irritation)
Biocompatibility (Dermal Sensitization)	Dermal Sensitization	Passes (No contact sensitizer)

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

The document does not explicitly state the sample sizes used for each test. The tests are based on ASTM standards (D 6319 – 00ae3, D 6124 – 01) and FDA regulations (21 CFR 800.20, FDA 1000 ml Water Leak Test). These are standard test methods and it can be inferred that samples were taken from manufactured batches for testing. The data provenance is not specified beyond indicating compliance with US standards. It is implied to be prospective testing for product qualification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the acceptance criteria are based on standardized laboratory tests and regulatory requirements, not on expert consensus or interpretation of medical images.
Adjudication method for the test set:

This is not applicable. The tests involve objective measurements against predefined standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, a multi-reader multi-case comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices (e.g., AI in radiology), not for physical medical devices like examination gloves.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable. This refers to an "algorithm only" performance, which is relevant for AI/software as a medical device, not for the physical examination gloves described.
The type of ground truth used:

The ground truth is based on established scientific and regulatory standards. For example:
- Dimensions, Physical Properties, Freedom from Pinholes: Objectively measured against the requirements specified in ASTM D 6319 – 00ae3 and FDA 21 CFR 800.20.
- Powder Free Residue: Objectively measured against the requirements of ASTM D 6124 - 01.
- Biocompatibility: In-vivo animal tests (Primary Skin Irritation in Rabbits, Dermal Sensitization tests) with predefined pass/fail criteria.
The sample size for the training set:

This is not applicable. There is no mention of a "training set" as this device is a physical product and its performance is evaluated through direct testing against predetermined standards, not through machine learning or AI models that require training data.
How the ground truth for the training set was established:

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

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a logo with the letters "WRP" in white against a black, rounded hexagonal background. The letters are bold and sans-serif, with the "W" being the widest and the "P" being the narrowest. The logo has a slightly distressed or textured appearance, giving it a vintage or worn look. The overall design is simple and eye-catching.

PT. WRP Buana Multicorpora

Image /page/0/Picture/2 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text is "KO32011". The writing is in black ink on a white background. The text is slightly tilted.

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

1.1 ... (1)

510 (K) SUMMARY

AUG 1 9 2003

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 : 29 July , 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, and
	2). Multiple or Customers' Trade Name
Device Name	Powder Free White Nitrile Examination Gloves, 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, 80LZA, powder free, that meets all the requirements of ASTM standard D 6319 -- 00a83 and FDA 1000 ml Water Leak Test.

5.0 Description of The Device :

The Powder Free White Nitrile Examination Gloves, Non sterile meets all the requirements of ASTM standard D 6319 – 00a83 and FDA 1000 ml Water Leak Test.

6.0 Intended Use of the Device :

The Powder Free White Nitrile Examination Gloves, 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.

$\kappa5\overline{3}$

Page 1 of 2

Your Partner In Protection™

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the text "PT. WRP Buana Multicorpora" in a bold, sans-serif font. The text is arranged horizontally, with each word clearly legible. The overall impression is that of a company name or title, presented in a straightforward and professional manner.

Image /page/1/Picture/1 description: The image shows a handwritten text that appears to be a signature or code. The text includes the letters 'Ko' followed by the numbers '32011'. The text is written in black ink on a white background and has a slightly tilted orientation.

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

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

Summary of The Technological Characteristics of The Device : 7.0

The Powder Free White Nitrile Examination Gloves, Non Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards.

CHARACTERISTICS	STANDARDS	DEVICEPERFORMANCE
Dimensions	D 6319 – 00ae3	Meets
Physical Properties	D 6319 - 00ae3	Meets
Freedom from Pinholes	D 6319 - 00ae3FDA 21 CFR 800.20	Meets
Powder Free Residue	D 6124 - 01	Meets< 2 mg/glove
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 White Nitrile Examination Gloves, 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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

AUG 1 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K032011

Trade/Device Name: Powder Free White Nitrile Examination Gloves, Non-Sterile Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 30, 2003 Received: August 4, 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.

{3}------------------------------------------------

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 vou 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 Runne

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

{4}------------------------------------------------

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 dark 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

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

INDICATIONS FOR USE

Applicant	: PT. WRP Buana Multicorpora
510(k) Number (if known)	: K032011
Device Name	: POWDER FREE WHITE NITRILE EXAMINATIONGLOVES NON STERILE

Indications For Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Olin S. him

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

510(k) Number: K032011

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

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.