NITRILE EXAMINATION GLOVES POWDER FREE (BLUE)

K991779 · Seltom Pacific Sdn. Bhd. · LZA · Aug 11, 1999 · General Hospital

Device Facts

• Record ID: K991779
• Device Name: NITRILE EXAMINATION GLOVES POWDER FREE (BLUE)
• Applicant: Seltom Pacific Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 11, 1999
• 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 similar personnel to prevent contamination between healthcare personnel and patient. It is a single use disposable glove.

Device Story

Nitrile powder-free patient examination gloves; single-use disposable barrier; worn on hands of healthcare personnel; prevents cross-contamination between clinician and patient; non-sterile.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nitrile material; powder-free; non-sterile; blue color; single-use form factor.

Indications for Use

Indicated for use by healthcare and similar personnel as a single-use, disposable 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

And II DUA

Mr. S. Segaran Managing Director Seltom Pacific SDN. BHD. Lot 25 Jalan PJS 7/17 Sunway Industrial Park 46150 Petaling Jaya, Selangor, Malaysia

RE: K991779 Trade Name: Nitrile Examination Gloves Powder Free (Blue) Requlatory Class: I Product Code: LZA Dated: June 28, 1999 Received: July 02, 1999

Dear Mr. Segaran:

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 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 regulations 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 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: 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.

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Page 2 - Mr. Segaran

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 xitro 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 Other general information on your responsibilities CFR 807.97). 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. Ulstanski

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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## SELTOM PACIFIC SDN. BHD.

Image /page/2/Picture/1 description: The image shows the words "SELTOM PACIFIC" stacked on top of each other. The word "SELTOM" is on the top line, and the word "PACIFIC" is on the bottom line. The text is in a bold, sans-serif font. The image is in black and white.

(CO. NO. 256686-M) Lot 25, Jalan PJS 7/17, Sunway Industrial Park, 46150 Petaling Jaya, Selangor, Malaysia.

603-7356010 -5826010 603-7342713 I: [e-mail]

## INDICATIONS FOR USE

Applicant SELTOM PACIFIC SDN BHD

510(k) Number K991779

Device Name Nitrile Powder Free Patient Examination Gloves (BLUE), Non-stenie

Indications for Use:-

ﻳﺰ.. ﺴ

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

It is a single use disposable glove.

Clun S. Lin

(Division Sign-Off) (Division Sign-Only and General Hospital 510(k) Number .