POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)

K991511 · Perusahaan Getah Asas Sdn. Bhd. · LZA · Jun 3, 1999 · General Hospital

Device Facts

• Record ID: K991511
• Device Name: POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)
• Applicant: Perusahaan Getah Asas Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Jun 3, 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; worn by healthcare providers during medical examinations; acts as a protective barrier to prevent cross-contamination between examiner and patient; non-sterile; powdered; natural color.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nitrile material; powdered; disposable; non-sterile; examination glove form factor.

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 Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1993 JUN

Mr. Tan Kong Chang Executive Director PERUSAHAAN GETAH ASAS SDN. BHD. Lot. 754, Jalan Haji Sirat, Off Jalan Kapar, 42100 Klanq, P.O. Box 188, 41720 Klang, Selangor, Darul Ehsan, MALAYSIA

Re : K991511 Trade Name: Powdered Nitrile Examination Glove, White (Non-Colored) Requlatory Class: I Product Code: LZA Dated: April 27, 1999 Received: April 30, 1999

Dear Mr. Chang:

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 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 requlation may result in regulatory action.

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

Page 2 - Mr. Chang

In addition, FDA may publish further announcements concerning your device in the Federal Register.

this response to your premarket notification Please note: Flease note: "Chip reflect any obligation you might have under sections 531 through 542 of the Act for devices under the Scettons 301 chrough tontrol provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as first receir will as 10 (k) premarket notification. The FDA acboing of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marice 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 regaracion (stic 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 ene regaration" (21 CFR 807.97). Other general premation 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

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

Enclosure

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

Section 3

510 (K) Number (if known) : K99 151

Device Name

: Nitrile Patient Examination Glove, Powdere (NATURAL COLOR)

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 )

Qun S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hosp 510(k) Numbe

Page 1 of 1