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

K992496 · Kossan Latex Industries(M)Sdn Bhd · LZA · Aug 25, 1999 · General Hospital

Device Facts

• Record ID: K992496
• Device Name: POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
• Applicant: Kossan Latex Industries(M)Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Aug 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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.

Device Story

Disposable nitrile patient examination glove; blue or white color; worn by healthcare professionals during patient examinations; acts as a physical barrier to prevent cross-contamination between patient and examiner; intended for single use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nitrile material; powder-free; disposable; non-sterile; form factor is a hand-worn glove.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand or finger 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes, suggesting movement or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 25 1999

Mr. Lim Kwan Hwa Executive Director Kossan Latex Industries (M) SDN. BHD. Lot 16632, 5¼ Miles, Jalan Meru, 41050 Klang Selangor Darul Ehsan, MALAYSIA

Re : K992496 Powder-Free Nitrile Examination Glove, Blue Trade Name: or White (Non-Colored) Requlatory Class: J Product Code: LZA Dated: July 20, 1999 Received: July 26, 1999

Dear Mr. Lim Kwan Hwa:

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 reqistration, 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 Regulations, 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action.

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

Page 2 - Mr. Lim Kwan Hwa

concerning your device in the Federal Register. Please note: this response to your premarket notification submission does entb response onligation you might have under sections 531 noc arrect any obiligation 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 deberroom in for a four alence of your device to a legally marketed predicate device results in a classification for your marketed predicate amits 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 regaradiagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact che Dffice of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obeation free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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

| 510 (K) Number (if known) | K992496 |
|---------------------------|-------------------------------------------------------------------|
| Device Name | : Powder-free Nitrile Patient Examination Glove<br>BLUE AND WHITE |
| Indications For Use | : |

A 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.

## ( 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

( Optional Format 1-2-96 )

Based on Cin

(Division Sign-Off) Division of Demal, Infection Control, and General Hospital Devices 510(k) Number_KGg2496

Page 1 of 1 Section 3