DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCAL

K023490 · Wrp Asia Pacific Sdn. Bhd. · LYY · Jan 16, 2003 · General Hospital

Device Facts

• Record ID: K023490
• Device Name: DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCAL
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Jan 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder Free Latex Examination Gloves Coated with Skin-care ingredients and with Protein Content Labeling Claim are disposable devices intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable latex examination gloves; coated with skin-care ingredients (Vitamin A, B, E, α-Lipoic acid, Eucalyptus, Jojoba, emollient cream); powder-free; protein content ≤ 50 µg/g. Used by clinicians in medical settings to provide a barrier against contamination between patient and examiner. Device functions as a physical barrier; no electronic or mechanical components.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing including dimensions, physical properties, freedom from pinholes, powder content (ASTM D 6124-01), protein levels (ASTM D 5712-95), and biocompatibility (skin irritation and dermal sensitization).

Technological Characteristics

Material: Latex. Coating: Vitamin A, Vitamin B, Vitamin E, α-Lipoic acid, Eucalyptus, Jojoba, and emollient cream. Standards: ASTM D 3578-01aE2 (dimensions, physical properties), ASTM D 6124-01 (powder-free), ASTM D 5712-95 (protein level). Performance: < 2 mg/glove powder, < 50 µg/g protein. Biocompatibility: Passes primary skin irritation and dermal sensitization tests.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger 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

K023490

# 510(k) SUMMARY

JAN | 6 2003

#### 1.0 Submitter:

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

1 4 OCT 2002 Date of Summary Prepared:

## 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-X, and<br>2. Multiple or Customer's Trade Name |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Powder Free Latex Examination Gloves Coated with Skin care<br>Ingredients (Vitamin A, Vitamin B, Vitamin E, α-Lipoic acid,<br>Eucalyptus, Jojoba and Emollient Cream) and with Protein Content<br>Labeling Claim (50 micrograms or less) |
| Common Name: | Examination Gloves |
| Classification Name: | Patient Examination Gloves (per 21 CFR 880.6250) |

#### 4.0 Identification of The Legally Marketed Device:

Class I patient examination gloves, 80LYY, powder free, that meets all the requirements of ASTM standard D 3578 - 01a52 and FDA 21 CFR 800.20.

### 5.0 Description of The Device:

The Powder Free Latex Examination Gloves Coated with Skin-care ingredients and with Protein Content Labeling Claim (50 micrograms or less) meets all the requirements of ASTM standard D 3578 - 01a52 and FDA 21 CFR 800.

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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 enclosed in a rounded, black shape. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a similar font. Below the text is the number "1 4 7 8 1 7 V".

#### Intended Use of the Device: 6.0

The Powder Free Latex Examination Gloves Coated with Skin-care ingredients and with Protein Content Labeling Claim are disposable devices 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 Latex Examination Gloves Coated with Skin-care ingredients and with Protein Content Labeling Claim are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|-----------------------|------------------------------------------|-----------------------------------------|
| Dimensions | ASTM D 3578 - 01aE2 | Meets |
| Physical Properties | ASTM D 3578 - 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3578 - 01aE2<br>FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 01 | < 2 mg/glove |
| Protein Level | ASTM D 5712 - 95 | < 50 µg/g |
| 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.

#### 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.

# Vour Portner In Pentertinn "

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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 oval shape. To the right of the logo is the company name, "WRP Asia Pacific Sdn Bhd," also in a bold, sans-serif font. Below the company name is the number "147817 V".

### 10.0 Conclusion

It can be concluded that the Powder Free Latex Examination Gloves Coated with Skin-care ingredients and with Protein Content Labeling Claim will perform according to the glove performance standards referenced in section 7 above and meet ASTM standards, and FDA requirements. Consequently, this device is substantially equivalent to currently marketed devices.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, with flowing lines above them that resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JAN 16 2003

Re: K023490

Trade/Device Name: Powder Free Latex Examination Gloves Coated with Vitamin E, with Protein Content Labeling Claim (50 Micrograms o r Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: December 11, 2002 Received: December 16, 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. 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. Chow

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 [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) you may obtain. 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Timothy A. Ulatowski

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/5/Picture/0 description: The image shows a logo with the letters "WRP" in bold, white font. The letters are stacked horizontally, with "W" on the left, "R" in the middle, and "P" on the right. The letters are set against a solid black, hexagon-like shape with rounded corners. The logo has a simple, clean design.

P Asia Pacific Sdn Bhd

4 7 8 1 7 V

# INDICATIONS FOR USE

Applicant:

WRP Asia Pacific Sdn Bhd

K023490

510(k) Number (if known):

Device Name:

POWDER FREE LATEX EXAMINATION GLOVES COATED WITH SKIN CARE - INGREDIENTS (YFFALL A, VHAMIN B, VITAMIN E, a LAROFE AGID, ENGALYPTUS, JOHODA AND EMOLLIENT CREAM) AND WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

Indications For Use:

The Powder Free Latex Examination Glove Coated with Skin-care Ingredients is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number

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

*Clin Lin*

(Division Sign-Off)

Division of Anesthesiology, General Hospital,

Infection Control, Dental Devices

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