POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

K994354 · Flexitech Sdn. Bhd. · LYY · Jan 31, 2000 · General Hospital

Device Facts

• Record ID: K994354
• Device Name: POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
• Applicant: Flexitech Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Jan 31, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable latex examination glove; polymer coated; powder-free; features protein content labeling claim (50 micrograms or less). Worn by healthcare examiners to provide barrier protection; prevents cross-contamination between patient and examiner. Used in clinical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Latex material; polymer coated; powder-free; disposable; non-sterile; examination glove.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 31 2000

Mr. Y. F. Hew Factory Manager Flexitech Sdn. Bhd. Lot 5071, Batu 5½ Jalan Meru 41050 Klang Selangor, Malaysia

K994354 Re: Latex Examination Glove, Polymer Coated Trade Name: Powder Free Requlatory Class: I Product Code: LYY Dated: December 20, 1999 December 23, 1999 Received:

Dear Mr. Hew:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Hew

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 requlation (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 Radiological Health

Enclosure

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Lot 5071, Batu 5 1/2, Jalan Meru, 41050 Klang, Selangor, Malaysia. Tel: [phone] Fax: [phone]

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3.0 Indication for Use Statement.

INDICATION FOR USE

Applicant :

FLEXITECH SDN BHD

510(k) Number

K994354

Device Name:

Polymer Coated, Powder Free, Latex Examination Gloves WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LES

Indication For Use :

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

(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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Tivision Sign-Off) ovision of Dental, Infection C and General Hospital E 10(k) Number

Prescription Use Per 21 CFR 801.109 OR Over-The-Counter Use (Optional Format 1-2-96)