POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN LABELING CLAIM 50 MICROGRAM OR LESS

K993820 · Felda Rubber Corp. · LYY · Dec 2, 1999 · General Hospital

Device Facts

• Record ID: K993820
• Device Name: POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN LABELING CLAIM 50 MICROGRAM OR LESS
• Applicant: Felda Rubber Corp.
• Product Code: LYY · General Hospital
• Decision Date: Dec 2, 1999
• 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 and examiner.

Device Story

Powder-free latex examination glove; disposable; worn by healthcare personnel during patient examinations. Acts as a physical barrier to prevent cross-contamination between patient and examiner. Used in clinical settings. Benefits patient and examiner by reducing risk of pathogen transmission.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Latex material; powder-free; non-sterile; disposable; form-fitting glove design.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners on hands or fingers 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

DEC = 2 1999

Mr. Yunus Latif Felda Rubber Industries Sdn. Bhd. 7th Floor, Balai Felda, Jalan Gurney 1 54000 Kuala Lumpur, Malaysia

Re: K993820 Powder Free Latex Exam Gloves, Non-Sterile Trade Name: with Protein Labeling Claim 50 Microgram or Less Requlatory Class: I Product Code: LYY Dated: November 6, 1999 November 12, 1999 Received:

Dear Mr. Latif:

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಕ್ಕೆ 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 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. Latif

obligation you might have under sections 531 through 542 of obligation you mages 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 markeed producered wour 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 compriation and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to che regaracion Cherology Mabbandary 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,

Pastora Cucurella/for

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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## INDICATIONS FOR USE

Applicant : Kilang Barangan Getah FELDA Palong 15 (Felda Rubber Industries Sdn Bhd) 510(k) Number (if known) : Device Name : __ Powder Free Latex Examinatio Indications For 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 and examiner.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter

(Optional Format 1-2-96)

* For a new submission, do NOT fill in the 510(k) number blank.

S.B. in C.E.