NITRILE EXAMINATION GLOVES POWDER FREE (WHITE)

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three birds in flight, arranged in a stacked formation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image. AUG 11 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. S. Seqaran Managing Director Seltom Pacific SDN. BHD. Lot 25 Jalan PJS 7/17 Sunway Industrial Park 46150 Petaling Jaya, Selanqor, Malaysia RE: K991776 Trade Name: Nitrile Examination Gloves Powder Free (white) Requlatory Class: I Product Code: LZA Dated: June 28, 1999 Received: July 02, 1999 Dear Mr. Seqaran: 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 manufacturinq 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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. Please note: this response to your premarket notification submission does not affect any obliqation 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 requlations. {1}------------------------------------------------ Paqe 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 leqally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at Additionally, for questions on the promotion and (301) 594-4692. advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 Other qeneral 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.qov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski i A. Ulatowsk Director Division of Dental, Infection Control. and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## SELTOM PACIFIC SELTOM PACIFIC SDN. BHD. (CO. NO. 256686-M) Lot 25, Jalan PJS 7/17, Sunway Industrial Park, 46150 Petaling Jaya, Selangor, Malaysia. 603-7356010 -5826010 603-7342713 -Mail: seltom@pd.jaring.my ## INDICATIONS FOR USE Applicant ## SELTOM PACIFIC SDN BHD 510(k) Number Nitrile Powder Free Patient Examination Gloves, Now-Stern e Device Name Indications for Use:- A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. 1991776 It is a single use disposable glove. Chiu S. Lin (Division Sign-Off) (Division Sign-Only) Division of Dental, Infection Control, Division of Hospital D 510(k) Number