POWDERED NITRILE EXAMINATION GLOVES

K981133 · Servicom Services Sdn Bhd · LZA · Jun 5, 1998 · General Hospital

Device Facts

• Record ID: K981133
• Device Name: POWDERED NITRILE EXAMINATION GLOVES
• Applicant: Servicom Services Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Jun 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A medical glove is worn on the hand of healthcare and similiar personnel to prevent contamination between healthcare personnel and patient

Device Story

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

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nitrile rubber material; powdered; examination glove form factor; non-sterile; single-use.

Indications for Use

Indicated for use by healthcare 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)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 1698 JUN

Mr. N.S. Kumar Servicom® Services Sdn. Bhd. Quality Control Manager Suite FGH, 17th Floor Banqunan Angkasa Raya Jalan Ampang 50450 Kuala Lumpur, MALAYSIA

Re : K981133 Powdered Nitrile Examination Gloves Trade Name: Regulatory Class: I Product Code: LZA Dated: May 20, 1998 Received: May 20, 1998

Dear Mr. Kumar:

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, Druq, 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. ಗೆ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 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

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Page 2 - Mr. Kumar

through 542 of the Act for devices under the Electronic chrough 542 or the 1100 al 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 markets produced 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 oriec of compriand as as comprime by reference to Other general premarket notification" (21CFR 807.97). 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

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510(k) NUMBER (IF KNOWN) : K981133

POWDERED NITRILE EXAMINATION GLOVES DEVICE NAME :

INDICATIONS FOR USE:

A medical glove is worn on the hand of healthcare and similiar personnel to prevent contamination between healthcare personnel and patient

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use X (Optional Format 1-2-96)

300/HA000/

Olin S. Lam

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

510(k) Number K981133

SR-35