POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)

K972195 · Absolute Synthetic Technologies Malaysia Sdn. Bhd. · LZA · Jul 29, 1997 · General Hospital

Device Facts

• Record ID: K972195
• Device Name: POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
• Applicant: Absolute Synthetic Technologies Malaysia Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Jul 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

As a medical glove, worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Story

Powder-free nitrile examination glove; worn on hands of healthcare personnel; serves as protective barrier to prevent cross-contamination between patient and clinician; used in clinical settings; disposable.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

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

Indications for Use

Indicated for use by health care and similar personnel as a protective barrier to prevent cross-contamination between the wearer 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 logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and three curved lines extending from the bottom of the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 29 1997

K972195

Absolute Synthetic Technologies Malaysia Sdn. Bhd. C/O Mr. Tom Bowman Project Chemist Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

K972195 Re : Powder-Free Nitrile Examination Glove, Blue Trade Name: Or White (Non-Colored) Regulatory Class: 工 LZA Product Code: Dated: July 14, 1997 Received: July 16, 1997

Dear Mr. Bowman:

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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices:

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

Page 2 - Mr. Bowman

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 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 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,

Patrici Cucentiffor

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}------------------------------------------------

## INDICATIONS FOR USE

Absolute Synthetic Technologies Malaysia Sdn. Bhd. Applicant:

510(k) Number:

Device Name: Powder-Free Nitrile Examination Glove, Blue or White (non-colored)

Indications for Use:

As a medical glove, worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

| (Division Sign-Off) | Patara Canti |
|----------------------------------------|--------------|
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K972195 |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

Over-The-Counter______________________________________________________________________________________________________________________________________________________________