LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE

K991749 · La Glove (M) Sdn. Bhd. · LYY · Jun 23, 1999 · General Hospital

Device Facts

• Record ID: K991749
• Device Name: LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE
• Applicant: La Glove (M) Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Jun 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

LAGLOVE™ Brand Blue Color Latex Examination Glove, Powder Free containing 50 µgm or less of water extractable protein per gram is a disposable device which is worn on the hand of a healthcare worker to prevent contamination between patient and examiner.

Device Story

LAGLOVE™ Brand Blue Color Latex Examination Glove is a powder-free, disposable glove. It is worn by healthcare personnel during patient examinations to provide a protective barrier against cross-contamination between the patient and the examiner. The device is intended for over-the-counter use.

Clinical Evidence

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

Technological Characteristics

Material: Latex. Type: Powder-free. Protein content: 50 µgm or less of total water extractable protein per gram. Form factor: Disposable examination glove. Color: Blue.

Indications for Use

Indicated for use as a disposable patient examination glove 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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three stylized birds in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 23 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

Re : K991749

LAGLOVE™ Brand Blue Color Latex Trade Name: Examination Glove, Powder-Free Contains 50 µgm or Less of Total Water Extractable Protein Per Gram Regulatory Class: I Product Code: LYY Dated: May 20, 1999 Received: May 24, 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 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 (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. A 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 regulation may result in regulatory action. In

{1}------------------------------------------------

## Page 2 - Mr. Baskaran

this response to your premarket notification Please note: submission does not affect any 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

{2}------------------------------------------------

Indications for use 3.0

| Applicant | : LAGLOVE (M) SDN. BHD. |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | : K991749 |
| Device name | : LAGLOVE™ Brand Blue Color<br>Latex Examination Gloves, Powder Free<br>containing 50 µgm or less of water<br>extractable protein per gram. |

Indications for use:

LAGLOVE™ Brand Blue Color Latex Examination Glove, Powder LAGOVE - Brand Dial - Brand - Dracer extractable protein per gram is Free containing 30 pgin of less of glove which is worn on the hand of a ulsposable patient callimation governt 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)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use X

(Optional Format 1-2-96)

Qiin S. Lim
(Division Sign-Off)

Division Off Off-Off)
Division of Dental, Infection Control, and General Hospital 510(k) Number

Optional Format 1-2-96