POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE

K012048 · Wrp Asia Pacific Sdn. Bhd. · LZA · Aug 16, 2001 · General Hospital

Device Facts

• Record ID: K012048
• Device Name: POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder Free Neoprene 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.

Device Story

Disposable neoprene examination gloves; worn by healthcare examiners to provide barrier protection; prevents cross-contamination between patient and examiner; non-sterile; powder-free; used in clinical settings.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including dimensions, physical properties, freedom from pinholes (ASTM D 3578-00, FDA 21 CFR 800.20), powder-free residue (ASTM D 6124-00), and biocompatibility (primary skin irritation and dermal sensitization).

Technological Characteristics

Material: Neoprene. Powder-free (< 2 mg/glove). Standards: ASTM D 3578-00 (dimensions, physical properties, pinholes), ASTM D 6124-00 (powder residue), FDA 21 CFR 800.20 (pinholes). Biocompatibility: Passed primary skin irritation and dermal sensitization tests.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent 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.

Submission Summary (Full Text)

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WRP Asia Pacific Sdn Bhd

AUG 1 6 2001

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

MALAYSIA

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

# 510(k) SUMMARY

#### Submitter: 1.0

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

Date of Summary Prepared: June 14, 2001

### Contact Person: 2.0

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

#### 3.0 Name of the device:

| Trade Name: | 1. DermaSafe, and |
|----------------------|------------------------------------------------------|
| | 2. Multiple or Customer's Trade Name |
| Device Name: | Powder Free Neoprene Examination Gloves, Non-Sterile |
| Common Name: | Examination Gloves |
| Classification Name: | Patient Examination Gloves (per 21 CFR 880.6250) |

# Identification of The Legally Marketed Device: 4.0

Class I patient examination gloves, 80LZA, powder free, that meets all the Class - 1 patient - C.TM standard D 3578 - 00 and FDA 21 CFR 800.20.

## Description of The Device: 5.0

The Powder Free Neoprene Examination Gloves, Non Sterile meets all the The Towder 1160 - Neopandard D 3578 - 00 and FDA 21 CFR 800.20.

Page 1 of 3

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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, sans-serif font, with the letters in white against a black background. To the right of the letters is the company name, "WRP Asia Pacific Sdn Bhd," in a smaller, sans-serif font.

## Intended Use of the Device: 6.0

Clarron Eng All Dononna"

The Powder Free Neoprene 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.

# Summary of The Technological Characteristics of The Device: 7.0

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

| CHARACTERISTICS | STANDARDS | DEVICE<br>PERFORMANCE |
|-----------------------|---------------------------------------|-----------------------------------------|
| Dimensions | ASTM D 3578 - 00 | Meets |
| Physical Properties | ASTM D 3578 - 00 | Meets |
| Freedom from pinholes | ASTM D 3578 - 00<br>FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 00 | Meets<br>< 2 mg/glove |
| Biocompatability | Primary Skin Irritation in<br>Rabbits | Passes<br>(Not a primary skin irritant) |
| | Dermal Sensitization | Passes<br>(Not a contact sensitizer) |

# 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.

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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, with the letters overlapping each other. To the right of the letters is the text "WRP Asia Pacific Sdn Bhd" in a smaller, sans-serif font. The logo is black and white.

# 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.

#### Conclusion 10.0

It can be concluded that the Powder Free Neoprene 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 waterleak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2001

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

K012048 Re : Powder Free Neoprene Examination Trade/Device Name: Gloves, Non Sterile Regulation Number: 880.6250 Regulatory Class: I Product Code: LZA Dated: June 14, 2001 Received: June 29, 2001

Dear Mr. Chow:

We have reviewed your Section 510(k) notification of intent to we have reviewed your boosed above and we have determined the market the device forly equivalent (for the indications for use stated in the enclosure) to legally marketed predicate use stated in the encreate commerce prior to May 28, 1976, devices marketed in theormedical Device Amendments, or to the enactment ado on reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions of the reachar robe, subject to the general controls provisions of the Act. The general controls controls provisions of include requirements for annual provisions of the nee increat as as a manufacturing practice, labeling, and prchibitions against misbranding and adulteration.

If your device is classified (see above) into either class II II your device ID Crabblass III (Premarket Approval), it may (Special concrold) of Stimal controls. Existing major be subject to back address an be found in the Code of Fegulations artists, Title 21, Parts 800 to 895. A rederal negularies, and determination assumes compliance with substantlarly equivalenc aring Practice requirements, as set the carrent souality System Regulation (QS) for Medical Forch In the gailation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug through periodic QS inspections) one book assumptions. Failure to

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Page 2 - Mr. Chow

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 not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Patricia Cicuente /for

Timothy A. Ulatowski 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 the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a stylized font inside of a black oval. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a sans-serif font. Below the text is the number sequence "1 4 7 8 1 7 V".

# INDICATIONS FOR USE

Applicant:

WRP Asia Pacific Sdn Bhd

510(k) Number (if known):

K012048

Device Name:

POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE

Indications For Use:

The Powder Free Neoprene Examination Gloves, Non Sterile is a disposable I he Fowder Tree Teopreno Lhanhan intended for medical purposes that is worn device and is made or synthette race of amination between patient and examiner.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Olin S. Lin

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

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