LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)

K990268 · La Glove (M) Sdn. Bhd. · LYY · Feb 24, 1999 · General Hospital

Device Facts

• Record ID: K990268
• Device Name: LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)
• Applicant: La Glove (M) Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Feb 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

Laglove™ Brand Polymer Coated Latex examination glove (powder free) is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

Device Story

Laglove™ Brand Polymer Coated Latex Examination Glove (Powder-Free) is a disposable, non-sterile latex glove. Designed for use by healthcare and similar personnel to provide a protective barrier; prevents cross-contamination between patient and examiner during clinical procedures. Device is worn on the hands; functions as a physical barrier. Benefits include reduction of potential pathogen transmission during patient examinations.

Clinical Evidence

Bench testing only. Device meets requirements for powder-free latex examination gloves, including a protein claim of 50 micrograms or less of total water extractable protein per gram.

Technological Characteristics

Material: Latex. Type: Powder-free examination glove. Feature: Polymer coated. Protein content: ≤ 50 micrograms/gram. Sterilization: Not specified.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier worn on the hands to prevent contamination between the patient and the 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

FEB 2 4 1999

Mr. G. Baskaran Managing Director Laglove (M) Sdn. Bhd. Lot 478, Jalan Simpang Balak, Off Batu 13, Jalan Cheras, 43000 Kajang, Selangor Darul Ehsan MALAYSIA

K990268 Re :

Laglove™ Brand Polymer Coated Latex Trade Name: Examination Glove (Powder-Free) Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulatory Class: I Product Code: LYY January 25, 1999 Dated: Received: January 28, 1999

Dear Mr. Baskaran

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 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 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 regulation 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 obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Baskaran

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 acboring 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.fdaffgov/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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K990268

3.0 Indications for use

: LAGLOVE (M) SDN. BHD.

Applicant 510(k) number Device name

Indications for use:

Laglove™ Coated Latex Polymer Brand (Powder Free) Examination -Gloves Profein claim of somegen are less of Total water sytractable professo per quam

Laglove™ Brand Polymer Coated Latex examination glove (powder Lagiove - Drand Forymer examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

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510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

?rescription Use Per 21 CFR 801.109)

OR
Olin S. Lin
Over-The-Counter Use X

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

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