DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE

K022904 · Wrp Asia Pacific Sdn. Bhd. · LZA · Oct 3, 2002 · General Hospital

Device Facts

• Record ID: K022904
• Device Name: DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Oct 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder Free Blue Nitrile Examination Glove, Non Sterile 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.

Device Story

Disposable non-sterile examination glove; made of synthetic nitrile rubber; worn on examiner's hand or finger; acts as physical barrier to prevent cross-contamination between patient and examiner; used in general medical settings; no electronic or mechanical components.

Clinical Evidence

No clinical data provided; substantial equivalence supported by non-clinical bench testing including dimensions, physical properties, pinhole testing, powder residual analysis, and biocompatibility (skin irritation and dermal sensitization).

Technological Characteristics

Synthetic nitrile rubber; powder-free; non-sterile; meets ASTM D 6319-00aE3 (dimensions, physical properties, pinhole freedom) and ASTM D 6124-01 (powder residual < 2 mg/glove); biocompatible (non-irritant, non-sensitizer).

Indications for Use

Indicated for use as a disposable, non-sterile, synthetic rubber glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner in medical settings.

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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# 510(k) SUMMARY

KC22904

#### 1.0 Submitter:

Name: Address:

Phone No .:

Fax No.:

WRP Asia Pacific Sdn Bhd Lot 1, Jalan 3, Kawasan Perushaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA [phone] 8706 1485

2002 Date of Summary Prepared: 3 0 AUG

#### 2.0 Contact Person:

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

#### 3.0 Name of the device:

| Trade Name: | 1) Dermagrip-N, and<br>2) Multiple or Customers' Trade Name |
|----------------------|-------------------------------------------------------------|
| Device Name: | Powder Free Blue Nitrile Examination Gloves, Non-Sterile |
| Common Name: | Examination Gloves |
| Classification Name: | Patient Examination Gloves (per 21 CFR 880.6250) |

#### 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 - 00a53 and FDA 21 CFR 800.20.

#### 5.0 Description of The Device:

VA..... D....... ... T.. D... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Powder Free Blue Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00a53 and FDA 21 CFR 800.20.

TM

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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 inside of a rounded shape. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a standard font. Below the text is the number sequence "1 4 7 8 1 7 V".

#### 6.0 Intended Use of the Device:

The Powder Free Blue Nitrile Examination Glove, Non Sterile 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.

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

The Powder Free Blue Nitrile 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 6319 - 00aE3 | Meets |
| Physical Properties | ASTM D 6319 - 00aE3 | Meets |
| Freedom from pinholes | ASTM D 6319 - 00aE3<br>FDA 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 6124 - 01 | 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) |

#### 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 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 white, inside of a black oval. To the right of the logo is the company name, "WRP Asia Pacific Sdn Bhd" in black text. Below the company name is the number "1 4 7 8 1 7 V".

#### 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 Blue 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 waterleak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines that suggest the shape of a human profile.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 03 2002

Mr. Yue Wah Chow Head of Department, QA/RA WRP Asia Pacific Sdn. Bhd. Lot 1. Jalan 3. Kawasan Perusahaan Bandar Baru Salak Tinngi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

Re: K022904

Trade/Device Name: Dermagrip Powder-Free Blue Nitrile Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: 80 LZA Dated: August 30, 2002 Received: September 3, 2002

### Dear Mr. Chow:

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. Fxisting 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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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 CHR 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,

Timoth 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/5/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 inside of a black shape. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a clear, sans-serif font. The text is smaller than the logo, but still easily readable.

## INDICATIONS FOR USE

| Applicant: | WRP Asia Pacific Sdn Bhd |
|---------------------------|-------------------------------------------------------------|
| 510(k) Number (if known): | K022904 |
| Device Name: | POWDER FREE BLUE NITRILE<br>EXAMINATION GLOVES, NON-STERILE |

Indications For Use:

The Powder Free Blue Nitrile Examination Glove, Non Sterile is a disposable device and is 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Qun S. Lim

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ision Sign-Off) on of Anesthesiology, General Hospital ion Control, Dental Devi

510(k) Number: K022964

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