POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM

K993287 · Pan-Century Rubber Products Sdn. Bhd. · LYY · Oct 29, 1999 · General Hospital

Device Facts

• Record ID: K993287
• Device Name: POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
• Applicant: Pan-Century Rubber Products Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Oct 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Powder-free, silicon-coated latex examination glove; intended for use by healthcare professionals during patient examinations to provide a barrier against contamination. Device is disposable; worn on hands or fingers. Provides protection for both patient and examiner. Manufactured by Pan-Century Rubber Products Sdn. Bhd.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Material: Latex; Surface: Silicon coated; Form: Powder-free examination glove; Protein content: 50 micrograms or less.

Indications for Use

Indicated for use as a disposable medical device 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)

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Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 1999

Mr. P. Sundaram General Manager (Marketing) Pan-Century Rubber Products Sdn. Bhd. Lot No. 230, Jalan Timah 2 Pasir Gudang Industrial Estate 81700 Pasir Gudang Johor, MALAYSIA

Re : K993287 Trade Name: Powder Free (Silicon Coated) Latex Examination Gloves with Protein Labelling Claim, 50 Micrograms or Less Regulatory Class: I Product Code: LYY September 28, 1999 Dated: Received: October 1, 1999

Dear Mr. Sundaram:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/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 Radioloqical Health

Enclosure

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Image /page/2/Picture/2 description: The image shows a logo for a quality system. The logo consists of a black diamond shape with the words "QUALITY SYSTEM" written in white inside a white oval shape at the top. Below the diamond, the text "SIRIM QUALITY SYSTEM MS ISO 9002 REGISTRATION NO 0400" is printed in black.

CENTURY RUBBER PRODUCTS SDN. BHD.

or No. 230, Jalan Timah 2, Pasir Gudang Industrial Estate, 81700 Pasir Gudang, Johor, Malaysia. Tel: [phone] Fax : [phone]

Image /page/2/Picture/5 description: The image shows a black and white logo. The logo appears to contain the letters 'PC' in a stylized font. The letters are partially obscured by a circular shape that surrounds them. The top of the logo features two bulbous shapes connected by thin lines, resembling a stylized representation of a chemical flask or a similar scientific apparatus.

ANNEXURE 'A'

OCTOBER 20, 1999

## GLOVE REVIEW SUMMARY K 993287

POWDER FREE ( SILICON COATED ) LATEX EXAMINATION GLOVES. WITH PROTEIN LABELING CLAIM (50 micrognam or less

INDICATION FOR USE STATEMENT

A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Olin S. lin

(Paurinn Sign-Off) Control of Dental, Infection Control a General Hospital De 5 i O(k) Number _