DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM O

K021561 · Wrp Specialty Products Sdn. Bhd. · LYY · Jun 11, 2002 · General Hospital

Device Facts

• Record ID: K021561
• Device Name: DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM O
• Applicant: Wrp Specialty Products Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Jun 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) 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

Sterile, powder-free latex examination glove; intended for use by healthcare professionals to prevent contamination between patient and examiner. Device acts as a physical barrier. Performance verified against ASTM D 3578-01e1 standards for dimensions, physical properties, and pinhole resistance. Features low protein content (< 50 μg/g) and low powder residue (< 2 mg/glove). Biocompatibility confirmed via rabbit skin irritation and dermal sensitization testing.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including ASTM standard compliance for physical properties, dimensions, pinhole AQL, powder residue, protein levels, and biocompatibility (skin irritation and sensitization).

Technological Characteristics

Latex material; powder-free; sterile. Meets ASTM D 3578-01e1 (dimensions, physical properties, pinholes), ASTM D 6124-00 (powder residue), and ASTM D 5712-99 (protein content). Biocompatible per primary skin irritation and dermal sensitization testing.

Indications for Use

Indicated for use as a disposable medical glove 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.

Submission Summary (Full Text)

{0}------------------------------------------------

# JUN 1 1 2002

## 510(k) Summary

| 1.0 | Submitter: | K021561 |
|-----|------------|---------------------------------------------------------------------------------------------------------------|
| | Name | WRP Specialty Products Sdn. Bhd. |
| | Address | Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak<br>Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| | Phone No. | [phone] |
| | Fax No. | [phone] |

Date of Summary Prepared April 8, 2002 :

### 2.0 Contact Person:

| Name: | Mr. V. Nadarajan |
|------------|------------------|
| Phone No.: | [phone] |
| Fax No.: | [phone] |

### 3.0 Name of the device:

| Proprietary or Trade Name | : 1. | Dermagrip, and |
|---------------------------|------|----------------------------------------------------------------------------|
| | : 2. | Multiple or Customer's Trade Name |
| Classification Name | : | Patient Examination Gloves (per 21 CFR 880.6250) |
| Device Name | : | Powder Free Latex Examination<br>Glove, Sterile (Protein Content Labeling) |

#### 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 - 0161 and FDA 21 CFR 800.20.

### 5.0 Description of The Device:

The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) meets all the requirements of ASTM standard D 3578 - 01°1 and FDA 21 CFR 800.20.

{1}------------------------------------------------

#### 6.0 Intended Use of the Device:

The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) are disposable devices intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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

The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| Characteristics | Standards | Device Performance |
|-----------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------|
| Dimensions | ASTM D 3578 - 01ε1 | Meets |
| Physical Properties | ASTM D 3578 - 01ε1 | Meets |
| Freedom from pinholes | ASTM D 3578 - 01ε1<br>FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 00 | < 2 mg/glove |
| Protein Level | ASTM D 5712 - 99 | < 50 μg/g |
| Biocompatability | Primary Skin Irritation in<br>Rabbits<br>Dermal Sensitization | Passes<br>(Not a primary skin irritant)<br>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.

#### 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 Latex Examination Glove, Sterile (Protein Content Labeling) 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.

{2}------------------------------------------------

Image /page/2/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 image of three human profiles facing right, with flowing lines suggesting movement or progress. The profiles are arranged in a row, slightly overlapping each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the image.

JUN 1 1 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. V. Nadarajan Manager QA/RA Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang Selangor Darul Ehsan, MALAYSIA

Re: K021561

Trade/Device Name: Dermagrip and Multiple Powder Free Latex Examination Glove Sterile with Protein Content Labeling Claim (50 Micrograms of Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: April 8, 2002 Received: May 13, 2002

Dear Mr. V. Nadarajan:

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.

{3}------------------------------------------------

# Page 2 - Mr. V. Nadarajan

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,

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

{4}------------------------------------------------

# INDICATIONS FOR USE

| Applicant | WRP Specialty Products Sdn Bhd |
|---------------------------|-------------------------------------------------------------------------------|
| 510(k) Number (if known): | K021561 |
| Device Name | POWDER FREE LATEX EXAMINATION<br>GLOVE, STERILE<br>(PROTEIN CONTENT LABELING) |

Indications For Use:

The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Olin S. Liven

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number __ r O'