GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT LABELING CLAIM 50UG/G OR LESS)

K022343 · Pt. Wrp Buana Multicorpora · LYY · Sep 16, 2002 · General Hospital

Device Facts

• Record ID: K022343
• Device Name: GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT LABELING CLAIM 50UG/G OR LESS)
• Applicant: Pt. Wrp Buana Multicorpora
• Product Code: LYY · General Hospital
• Decision Date: Sep 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

These gloves are intended to be worn on examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Powder-free natural rubber latex examination gloves; non-sterile; intended for use by healthcare examiners to prevent cross-contamination between patient and examiner. Device functions as a physical barrier. No electronic or mechanical components. Used in clinical settings.

Clinical Evidence

Bench testing only. Device complies with ASTM D 3578 standards and FDA 1000ml water leak test requirements. Protein content testing confirms levels are below 50 µg/g.

Technological Characteristics

Material: Natural rubber latex. Form factor: Examination glove. Compliance: ASTM D 3578, FDA 1000ml water leak test. Protein content: ≤ 50 µg/g. Non-sterile.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner.

Regulatory Classification

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.

Predicate Devices

• Powder Free Latex Examination Gloves, Non-Sterile (K970115)

Submission Summary (Full Text)

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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).
- 2. Device Name : Powder Free Latex Examination Gloves, Non Sterile (Protein Content Labeling Claim 50 ug/g or less).
- 3. Device Listing No. : A 907707
- 4. 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.

- 5. 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.

- 6. 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 | [phone] |
|-----|------------------|
| | [phone] |
| Fax | [phone] |
| URL | www.wrpworld.com |

### Comparison with a Predicate Devices

| Characteristics | Powder Free Latex<br>Examination Gloves, Non<br>Sterile. | Powder Free Latex<br>Examination Gloves, Non<br>Sterile with Protein<br>Content 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 the<br>examiner's hand or finger to<br>prevent contamination<br>between patient and<br>examiner | To be worn on the<br>examiner's hand or finger to<br>prevent contamination<br>between patient and<br>examiner |
| Comply with FDA 1000ml<br>Water Leak Test | Meets | Meets |
| Protein Content labeling<br>Claim (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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 [phone] [phone] 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:

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.

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

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