POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION GLOVES

K023866 · Kl-Kepong Rubber Products Sdn. Bhd. · LYY · Jan 24, 2003 · General Hospital

Device Facts

• Record ID: K023866
• Device Name: POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION GLOVES
• Applicant: Kl-Kepong Rubber Products Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Jan 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infections materials and other contaminants.

Device Story

Powder-free patient examination glove; composed of natural rubber latex with polymer coating. Device functions as a physical barrier to protect both patient and healthcare provider from infectious materials and contaminants during medical examinations. Used in clinical settings; disposable; single-use. Provides protection via material integrity; protein content labeled at 50 micrograms or less to reduce potential for allergic reactions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Natural rubber latex material; polymer coated; powder-free; disposable; non-sterile; protein content labeled at 50 micrograms or less.

Indications for Use

Indicated for use as a disposable medical glove worn on the hand or fingers to provide a barrier against infectious materials and contaminants for patients and healthcare providers.

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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JAN 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

·Ms. Yim Hoon Pung General Manager KL Kepong Rubber Products Sdn Bhd. Ladang Pinji, Bahagian Sengat, 31300 Kampung Kepayang, Ipoh, Perak Darul Ridzuan, MALAYSIA

Re: K023866

Trade/Device Name: Powder Free Polymer Coated (Acrylic Based) Latex Patient Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: November 19, 2002 Received: November 20, 2002

Dear Mr. Pung:

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. Pung

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,

Susa Russo

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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## 3.0 INDICATIONS FOR USE STATEMENT :

APPLICANT : KL KEPONG RUBBER PRODUCTS SDN. BHD.

| 510(K) | KO23866 |
|--------|---------|
|--------|---------|

DEVICE NAME POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTENCED OD IMER CORTED LATEX EXAMINA HON GLOVES
N FOR USE INDICATION FOR USE .

A powder-free patient examination glove is a disposable device

made of natural rubber latex or synthetic material that may bear a

trace amount of glove powder and is intended to be worn on the

hand or finger(s) for medical purposes to provide a barrier against

potentially infections materials and other contaminants.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clain Schim

Gener

510(k) Number: K023866