LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED)

K990883 · La Glove (M) Sdn. Bhd. · LZA · Aug 10, 1999 · General Hospital

Device Facts

• Record ID: K990883
• Device Name: LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED)
• Applicant: La Glove (M) Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Laglove™ Brand, Colored Nitrile Examination Glove (Powdered) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

Device Story

Disposable patient examination glove; worn on hands of healthcare personnel; acts as barrier to prevent cross-contamination between patient and examiner. Device is non-sterile, powdered, blue-colored nitrile. Used in clinical settings by healthcare workers. Provides physical barrier protection.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Nitrile rubber. Form factor: Disposable, powdered examination glove. Color: Blue. Energy source: None. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for use by healthcare and similar personnel as a disposable patient examination glove 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)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wing-like strokes above two wave-like strokes.

AUG 1 0 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re : K990883 Laglove™ Brand Blue Colored Nitrile Trade Name: Examination Glove Powdered Regulatory Class: I Product Code: LZA Dated: July 19, 1999 Received: July 23, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੈ 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 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}------------------------------------------------

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 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 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 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

Director 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

6 ...

Applicant 510(k) number Device name

: LAGLOVE (M) SDN. BHD. : K996883 : Laglove TM Brand Colored Nitrile (Blue) Examination Gloves (Powdered)

Indications for use:

Blue

Laglove™ Brand, Colored Nitrile Examination Glove (Powdered) is a
disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

Clus S. lin

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

510(k) Number K990883