NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL -7 1999 Mr. Chan Chin Hong General Manager Seal Polymer Industries Sdn. Bhd. Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak MALAYSIA Re : K991849 Non-Sterile Power-Free Latex Examination Trade Name: Gloves with a Protein Labeling Claim (50 Micrograms or Less Total Water Extractable Protein) Requlatory Class: I Product Code: LYY May 26, 1999 Dated: Received: June 1, 1999 Dear Mr. Chan Chin Hong: 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, qood 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 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 - Mr. Chan Chin Hong this response to your premarket notification Please note: Frease note: oneot affect any obligation you might have under sections 531 through 542 of the Act for devices under the Sections 351 chicagon Federal laws or regulations. This letter will allow you to begin marketing your device as fire ibed in your 510(k) premarket notification. The FDA described in your sia wequivalence of your device to a legally rinang or edicate device results in a classification for your markees promits 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 (301) 594-4692. Additionally, for questions on comprimee as (od advertising of your device, please contact che promocion analiance at (301) 594-4639. Also, please note ene orrios or entitled, "Misbranding by reference to ene regaration" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information of Job Division of Small Manufacturers Assistance obtained from cle bribers (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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 {2}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT : Seal Polymer Industries Sdn. Bhd. Applicant K991849 510(K) Number : : Cashmere Non-Sterile, Powder-Free Latex Examination Gloves Device Name Basic Non-Sterile, Powder-Free Latex Examination Gloves Indication For Use: This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment. > .............................................................................................................................................................................. Concurrence of CDRH Office of Device Evaluation (ODC) Prescription Use: ... .. Per 21 CFR 80.109 OR Ove Over-The-Counter X Chun S. Lin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital I 510(k) Number