LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)

K990420 · La Glove (M) Sdn. Bhd. · LZA · Mar 29, 1999 · General Hospital

Device Facts

• Record ID: K990420
• Device Name: LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)
• Applicant: La Glove (M) Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Mar 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Laglove™ Brand Nitrile Examination Glove (Powder Free) is a Lagiove - Drand Nitrine Examination glove which is worn on the hand of disposable patient exammation grove histor in ontamination between patient and examiner.

Device Story

Disposable nitrile examination glove; worn on hands of healthcare personnel; intended to provide a barrier to prevent cross-contamination between patient and examiner. Device is non-sterile, powder-free, and intended for single use in clinical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nitrile rubber material; powder-free; disposable; non-sterile; examination glove form factor.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the hand 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 black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is facing towards the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 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 : K990420 Laglove™ Brand Nitrile Examination Trade Name: Glove (Powder-Free) Regulatory Class: I Product Code: LZA Dated: February 8, 1999 February 10, 1999 Received:

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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Good Manufacturinq 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 obligation you might have under sections 531 through 542 of

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

Paqe 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 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

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

## 14990420

## Indications for use 3.0

: LAGLOVE (M) SDN. BHD. Applicant . 510(k) number : Laglove™ Brand Nitrile Examination Device name Gloves (Powder Free)

Indications for use:

Laglove™ Brand Nitrile Examination Glove (Powder Free) is a Lagiove - Drand Nitrine Examination glove which is worn on the hand of disposable patient exammation grove histor in ontamination 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) 10R

Over-The-Counter Use

(Optional Format 1-2-96)

Olin s. lin

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