LATEX POWDER FREE EXAMINATION GLOVES

K981942 · Maika Rubber Products Sdn Bhd · LYY · Dec 14, 1998 · General Hospital

Device Facts

• Record ID: K981942
• Device Name: LATEX POWDER FREE EXAMINATION GLOVES
• Applicant: Maika Rubber Products Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Dec 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A Latex Powder Free examination glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient

Device Story

Latex powder-free examination glove; worn on hands by healthcare or similar personnel; serves as protective barrier to prevent cross-contamination between user and patient. Device is non-sterile, disposable, and intended for general examination use in clinical or similar settings.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Latex rubber material; powder-free; examination glove form factor. Class I device, product code LYY.

Indications for Use

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

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 seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 1998

MAIKA Rubber Products Sdn. Bhd. C/O Mr. Ravi Anbil Indus Resources, Incorporated 1133 Fairlawn Avenue Libertyville, Illinois 60048

Re: K981942 Latex Powder-Free Examination Gloves Trade Name: Regulatory Class: I Product Code: LYY Dated: October 30, 1998 November 4, 1998 Received:

Dear Mr. Anbil:

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 legally marketed predicate 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 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531

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

Page 2 - Mr. Anbil

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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" (21CFR 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/dsma/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}------------------------------------------------

Maika Rubber Products Sdn. Bhd. No. 6 Lorong Perak 3 42500 Telok Panglima Garang Kuala Langat, Selangor Malaysia Tel : [phone] Fax : [phone]

Indication for Use Statement: 3.0 INDICATION FOR USE Applicant

MAIKA RUBBER PRODUCTS SDN. BHD. No. 6 Lorong Perak 3 42500 Telok Panglima Garang Kuala Langat, Selangor Malayusia

Latex Powder Free Examination Gloves

510(k) Number (if known): Device Name : Indication for Use : 1981942

" A Latex Powder Free examination glove is worn on the

hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient"

Prescription Use __

Over-The-Counter

Per 21 CFR 801.109

(Optional Format 1-2-96)

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

Olin S. Lin

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

3 of 10