ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES

K033530 · Asia Pacific Latex Sdn Bhd · LYY · Jan 28, 2004 · General Hospital

Device Facts

• Record ID: K033530
• Device Name: ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES
• Applicant: Asia Pacific Latex Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Jan 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder Free Latex Examination Gloves 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.

Device Story

Disposable powder-free latex examination glove; intended for use by healthcare personnel during patient examinations to provide a protective barrier against contamination. Device is worn on hands; functions as a physical barrier. No electronic, software, or algorithmic components. Used in clinical or hospital settings.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and compliance with regulatory standards for examination gloves.

Technological Characteristics

Material: Latex. Form factor: Disposable examination glove. Powder-free. Contains 50 micrograms or less of total water extractable protein per gram.

Indications for Use

Indicated for use as a disposable patient examination glove to be worn on the hands of healthcare personnel 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2004

Mr. Lee Son Hong Chief Executive Officer Asia Pacific Latex Sdn. Bhd. Lot 12, Medan Tasek, Tasek Industrial Estate, 31400 Ipoh, Perak Darul Ridzuan, MALAYSIA

## Rc: K033530

Trade/Device Name: Asia Pacific Latex Sdn. Bhd. Powder Free Latex Examination Gloves, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: December 6, 2003 Received: December 18, 2003

## Dear Mr. Hong:

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 adultcration.

If your device is classified (sec above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Nr.), I randy of the Codc of Federal Regulations, Title 21, Parts 800 to 898. In

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Page 2 - Mr. Hong

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. or the rece of any vote all the Act's requirements, including, but not limited to: registration 1 od intiles comply wart 807); labeling (21 CFR Part 801); good manufacturing practice and ifoung (21 cert forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as lectronic 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 promative nouted on one 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), n you deente specific at the 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 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 vours.

Chiu Lin, Ph., D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(K) Number (if known)

K 033530

Powder Free Latex Examination Gloves Powder Free Latex Extraction Clouden Clouden.

> The Powder Free Latex Examination Gloves is a disposable The Powder Free Lates, Examination That is worn on the device intended for medical parposer manager management patient and examiner.

Prescription Use (Part 21CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Ko33530

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pat Anf. Stetson Arnold Chef 1/2/04

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(Division Sign-Off) Division of Anesthesiology. General Hospital, Infection Control, Dental Devices

510(k) Number: K033530