DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGR

K021536 · Wrp Specialty Products Sdn. Bhd. · LYY · Jun 10, 2002 · General Hospital

Device Facts

• Record ID: K021536
• Device Name: DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGR
• Applicant: Wrp Specialty Products Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Jun 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The 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. The patient examination glove may also provides additional protection in other areas where users are handling certain hazardous chemical such as commonly used chemotherapy drugs, as penetration and permeation by these drugs are resisted.

Device Story

Disposable natural rubber latex examination glove; worn by clinicians to prevent cross-contamination between patient and examiner. Provides barrier protection against penetration and permeation of commonly used chemotherapy drugs. Used in clinical settings; non-sterile. Benefits include reduced risk of infection transmission and protection for healthcare workers handling hazardous chemical agents.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including physical properties, pinhole AQL, powder-free status, protein content (<50 µg/g), biocompatibility (skin irritation and sensitization), and chemotherapy drug permeation resistance.

Technological Characteristics

Natural rubber latex; powder-free (<2 mg/glove); protein content <50 µg/g. Dimensions and physical properties per ASTM D 3578-01. Pinhole resistance per ASTM D 3578-01 and FDA 21 CFR 800.20. Chemotherapy drug resistance per ASTM F 739-99a. Biocompatibility 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. Also indicated for use when handling certain hazardous chemicals, including commonly used chemotherapy drugs, to provide barrier protection.

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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JUN 1 0 2002

K021536

## 510(k) Summary

#### 1.0 Submitter:

. . . .

n

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

Date of Summary Prepared: 08 MAY 2002

## 2.0 Contact Person:

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

#### 3.0 Name of the device:

| Proprietary or Trade Name: | 1) Dermagrip, and<br>2) Multiple or Customer's Trade Name |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Patient Examination Gloves (per 21 CFR 880.6250) |
| Device Name: | Powder Free Latex Examination Gloves, Non-Sterile<br>with Protein Content Labeling Claim (50 Microgram<br>or less) and Tested for Use with Chemotherapy Drugs |

## 4.0 Identification of The Legally Marketed Device:

Class I patient examination gloves, 80LY, powder free, that meets all the requirements of ASTM standard D 3578 - 0151 and FDA 21 CFR 800.20.

#### 5.0 Description of The Device:

The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Microgram or less) and Tested for Use with_Chemotherapy Drugs meets all the requirements of ASTM standard D 3578 - 0151 and FDA 21 CFR 800.20.

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#### 6.0 Intended Use of the Device:

The 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.

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

The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Microgram or less) and Tested for Use with Chemotherapy Drugs is summarized with the following technological characteristics compared to ASTM or equivalent standards.

| Characteristics | Standards | Device Performance |
|-----------------------------------------------------------------------|-----------------------------------------|-----------------------------------------|
| Dimensions | ASTM D 3578 – 01EI | Meets |
| Physical Properties | ASTM D 3578 – 01EI | Meets |
| Freedom from pinholes | ASTM D 3578 – 01EI<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 Rabbits | Passes<br>(Not a primary skin irritant) |
| | Dermal Sensitization | Passes<br>(Not a contact sensitizer) |
| Resistance to<br>permeation by<br>commonly used<br>chemotherapy drugs | ASTM F 739 – 99a | Passes |

#### 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.

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#### Conclusion 10.0

It can be concluded that the Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Microgram or less) and Tested for Use with Chemotherapy Drugs 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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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

JUN 1 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. V. Nadarajan WRP Specialty Products Sdn. Bhd. Lot 11, Jalan 2, Kawasan Perusahaan B Baru Salak, Tinggi 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

Re: K021536

Trade/Device Name: Dermagrip and Multiple Powder Free Latex Examination Gloves with Protein Labeling Claim ( 50 Micrograms or Less ) and Tested for Use with Chemotherapy Drugs Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: May 8, 2002 Received: May 10, 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.

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Page 2 - Mr. 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 (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 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 Internetaddress http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timo 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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# INDICATIONS FOR USE

| Applicant: | WRP Specialty Products Sdn Bhd |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K021536 |
| Device Name: | POWDER FREE LATEX EXAMINATION<br>GLOVES, NON STERILE WITH PROTEIN<br>CONTENT LABELING CLAIM (50<br>MICROGRAM OR LESS) AND TESTED FOR<br>USE WITH CHEMOTHERAPY DRUGS |

Indications For Use:

The patient examination glove is a disposable device and is made of natural rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The patient examination glove may also provides additional protection in other areas where users are handling certain hazardous chemical such as commonly used chemotherapy drugs, as penetration and permeation by these drugs are resisted.

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Qium Si Lin,

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ 10 2

OR

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