POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

K012135 · Wrp Asia Pacific Sdn. Bhd. · KGO · Aug 1, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012135
• Device Name: POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Aug 1, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Protein Free Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) is made of natural rubber latex intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Device Story

Sterile, powder-free natural rubber latex surgical gloves; worn by surgeons and operating room personnel. Function as physical barrier to prevent contamination between healthcare personnel and patient body, fluids, waste, or environment. Used in clinical and surgical settings. Protects surgical wounds from contamination. No electronic or mechanical components.

Clinical Evidence

No clinical data. Substantial equivalence based on non-clinical bench testing including dimensions, physical properties, freedom from pinholes (ASTM D 3577-00, FDA 21 CFR 800.20), powder content (ASTM D 6124-00), protein levels (ASTM D 5712-95), and biocompatibility (primary skin irritation and dermal sensitization).

Technological Characteristics

Natural rubber latex; powder-free (max 2 mg/glove per ASTM D 6124-00); protein content < 50 µg/g (ASTM D 5712-95). Meets ASTM D 3577-00 for dimensions and physical properties. Biocompatible (non-irritant, non-sensitizer). Sterile.

Indications for Use

Indicated for use by surgeons and/or operating room personnel to protect a surgical wound from contamination. Intended for healthcare personnel to prevent cross-contamination between personnel and patients.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Submission Summary (Full Text)

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Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

1 2001 AUG

WRP Asia Pacific Sdn Bhd

# 510(k) SUMMARY

## Submitter: 1.0

| Name:<br>Address: | WRP Asia Pacific Sdn Bhd<br>Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak<br>Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Phone No.: | [phone] |
| Fax No.: | [phone] |

012135

0 3 JUL 2001 Date of Summary Prepared:

#### Contact Person: 2.0

| Name: | Mr. Yue Wah, CHOW |
|------------|-------------------|
| Phone No.: | [phone] |
| Fax No.: | [phone] |

### Name of the device: 3.0

| Trade Name: | 1. Profeel |
|----------------------|---------------------------------------------------------------------------|
| | 2. Multiple or Customer's Trade Name |
| Device Name: | Powder Free Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) |
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's Gloves (per 21 CFR 878.4460) |

## Identification of The Legally Marketed Device: 4.0

Class I Powder Free natural rubber latex Surgeon's gloves, 79KGO, that meets all
ed CER 800 2007 100 100 100 000 100 000 EDA 21 CER 800 20 Class I Powder Free natural Tuboci Tatex Cargood ogen of your and FDA 21 CFR 800.20.
the requirements of ASTM standard D 3577 -- 00 Type 1 and FDA 21 CFR 800.20.

## Description of The Device: 5.0

The Powder Free Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim)
Proveder Free Brown Career Steel D. 2677 - 00 and EDA 21 CFR The Powder Free Brown Latex Bargiour Cloves, Brond (
meets all the requirements of ASTM standard D 3577 - 00 and FDA 21 CFR 800.20.

) 4 7 8 1 7 V

TEL [phone] FAX [phone] EML [e-mail] URL www.wrpworld.com

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Image /page/1/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, stylized font, followed by the words "WRP Asia Pacific Sdn Bhd" in a smaller, but still bold, font. Below the company name is the number "147817 V".

#### 6.0 Intended Use of the Device:

The Protein Free Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) is made of natural rubber latex intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

#### Summary of The Technological Characteristics of The Device: 7.0

The Powder Free Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE<br>PERFORMANCE |
|-----------------------|---------------------------------------|-----------------------------------------|
| Dimensions | ASTM D 3577 - 00 | Meets |
| Physical Properties | ASTM D 3577 - 00 | Meets |
| Freedom from pinholes | ASTM D 3577 - 00<br>FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 00 | Meets<br>2 mg/glove maximum |
| Protein Level | ASTM D 5712 - 95 | < 50 $ \mu $ g/g |
| Biocompatability | Primary Skin Irritation in<br>Rabbits | Passes<br>(Not a primary skin irritant) |
| Dermal Sensitization | | Passes<br>(Not a contact sensitizer) |

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Image /page/2/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, sans-serif font, enclosed in a black hexagon shape. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a similar bold, sans-serif font.

K012135

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

The performance test data of the non-clinical tests that support a determination of substantial equivalence 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 Powder Free Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2001

Mr. Yue Wah Chow Head of Department, QA/Ra WRP Asia Pacific Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, Sepang Selangor MALAYSIA

K012135 Re : Powder Free Latex Surgical Gloves Trade/Device Name: With Protein Content Labeling Claim ( 50 Micrograms or Less ) Regulation Number: 878.4460 Requlatory Class: I Product Code: KGO Dated: July 3, 2001 Received: July 9, 2001

Dear Mr. Chow:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the markee 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). 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 provision, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug

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Page 2 - Mr. Chow

Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does ento response obligation you might have under sections 531 through 542 of the Act for devices under the Electronic enrough Siz or on Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deborized in four portalence of your device to a legally marketed predicate device results in a classification for your marice 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 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 che office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

thy A. Ulatowski Timõ Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows a logo with the letters "WRP" in white against a black, horizontally-oriented oval background. The letters are large and bold, taking up most of the space within the oval. The logo has a simple, clean design and is likely used to represent a company or organization with the initials WRP.

WRP Asia Pacific Sdn Bhd

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## INDICATIONS FOR USE

Applicant:

WRP Asia Pacific Sdn Bhd

KO12135

510(k) Number (if known):

Device Name:

POWDER FREE BROWN LATEX SURGICAL STERILE (PROTEIN GLOVES, LABELING CLAIM) 50 MIL ROGRAMS OR LIESS

Indications For Use:

The surgeon's glove is a device made of natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

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

Qim S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number _

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