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

K033532 · Asia Pacific Latex Sdn Bhd · LYY · Jan 28, 2004 · General Hospital

Device Facts

• Record ID: K033532
• Device Name: ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED 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

A 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 & examiner.

Device Story

Disposable patient examination glove; made of latex with polymer coating; powder-free; contains 50 micrograms or less of total water extractable protein per gram. Used in clinical settings by healthcare professionals to provide a protective barrier between examiner and patient, preventing cross-contamination. Device is worn on hands or fingers during medical examinations.

Clinical Evidence

Bench testing only.

Technological Characteristics

Latex material; polymer coated; powder-free; contains ≤ 50 micrograms/gram of total water extractable protein. Class I device per 21 CFR 880.6250.

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)

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## Public Health Service

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

Re: K033532

Trade/Device Name: Asia Pacific Latex Sdn. Bhd. Polymer Coated 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 Cosmctic 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. 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 mean that I Drimas made statutes and regulations administered by other Federal agencies. or the ret or any 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 and fishing (21 CFR in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as as 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) This letter wification. 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), rt you dontact 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 from the may obtain 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

Sincercly yours,

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 033532

Free Polymer Coated Powder Latex Examination Gloves Device Name Contains so migm or less of Total Water Extractable Pictern for gram

> A 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 & examiner.

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

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

unter Use
(Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Pat Roy Latimer Branch Chay 1/28/04

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

510(k) Number: K013532