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

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the device, based on the provided text:

Device: Powder Free Nitrile Examination Gloves, Blue, Non-Sterile

1. 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 FDA 1000 ml Water Leak Test	Meets
Powder Free Residue	D 6124 - 01	Meets (< 2mg/glove)
Biocompatibility: - Primary Skin Irritation - Dermal Sensitization	Primary Skin Irritation in Rabbits Dermal Sensitization	Passes (No primary skin irritation) Passes (No contact sensitizer)

Note: The document explicitly states that the device "meets all the requirements of ASTM standard D 6319 – 00a83 and FDA 1000 ml Water Leak Test" (Section 5.0 and 10.0), which are foundational for examination gloves.

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

Sample Size: Not explicitly stated in the provided text. The document refers to "performance test data of the non-clinical tests" but does not give specific sample sizes for each characteristic.
Data Provenance: The device manufacturer (PT. WRP Buana Multicorpora) is based in Indonesia. The testing standards mentioned (ASTM, FDA) are international/US standards, implying the testing was conducted to these requirements. The text does not specify the country of origin of the data collection beyond the manufacturer's location. The studies are described as "non-clinical tests." It is a prospective study as the data supports a premarket notification for a new device.

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

Not applicable as this is a non-clinical device (examination glove) and the testing involves physical and chemical property assessments rather than expert interpretation of medical images or patient conditions. The "ground truth" is established by adherence to defined ASTM and FDA engineering/testing standards.

4. Adjudication method for the test set:

Not applicable for this type of non-clinical device testing. The results are based on objective measurements against established 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-assisted diagnostic device.

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

Not applicable. This is not a software algorithm or AI device. The "standalone" performance refers to the intrinsic properties of the physical glove itself, tested against established standards.

7. The type of ground truth used:

For Dimensions, Physical Properties, Freedom from Pinholes, and Powder Free Residue: The ground truth is defined by established engineering and material testing standards (ASTM D 6319-00ae3, FDA 21 CFR 800.20, FDA 1000 ml Water Leak Test, ASTM D 6124-01). The device passes or fails based on objective measurements against these predefined thresholds.
For Biocompatibility (Primary Skin Irritation and Dermal Sensitization): The ground truth is established through pre-clinical animal testing (specifically in Rabbits for skin irritation). The "Passes" outcome indicates no adverse biological reaction following standard protocols.

8. The sample size for the training set:

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:

Not applicable. This is not an AI/machine learning device.

Summary

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Image /page/0/Picture/0 description: The image shows the text "PT. WRP Buana Multicorpora" in bold, black font. The text appears to be the name of a company. The text is horizontally aligned and takes up most of the image space. The background is plain white.

K03 2010

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

AUG 1 9 2003

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 : 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 Nitrile Examination Gloves, 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, 80LZA, powdered, 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 Nitrile Examination Gloves, Blue, 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 Nitrile Examination Glove, 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 logo with the letters "WRP" in a bold, sans-serif font. The letters are white and stand out against a black background. The logo has a slightly distressed or textured appearance, giving it a vintage or worn look. The overall shape of the logo is somewhat hexagonal or rounded, with the letters fitting snugly within the shape.

RP Buana Multicorpora

Image /page/1/Picture/2 description: The image shows a handwritten text that appears to read "KB2010". The text is written in a cursive style with thick, dark lines, making it easily readable against the white background. The characters are connected, giving the impression of a single, continuous stroke for each word. The overall impression is that of a quick, informal note or label.

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 Nitrile Latex Examination Gloves, Blue, 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< 2mg/ 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 Nitrile Examination Gloves, 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 is a black and white logo. The logo is circular and contains text around the perimeter. Inside the circle is a stylized image of a bird in flight. The text around the perimeter is "INSTITUTE OF REALITY & WOMAN MEDICINE USA".

Public Health Service

AUG 1 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K032010

Trade/Device Name: Powder Free Nitrile Examination Glove, Blue, 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.

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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 vours.

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

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Image /page/4/Picture/0 description: The image shows a black logo with the letters "WRP" in white. The letters are bold and sans-serif. The logo is in the shape of a rounded rectangle with slightly pointed corners. The background is black, and the letters are white, creating a high contrast.

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) :	K032010
Device Name	: POWDER FREE NITRILEEXAMINATION GLOVES, BLUE, NON STERILE

Indications For Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clins S. Lam

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

510(k) Number: K032010

OR Over-The-Counter _ Prescription Use (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.