POWDER FREE GLOVES (POLYMER COATED)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of three human profiles facing right, arranged in a stacked formation. The profiles are stylized with flowing lines, suggesting movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the seal in a circular fashion. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 1 9 1999 Mr. P. Sundaram General Manager (Marketing) Pan-Century Rubber Products Sdn. Bhd. Lot No. 230, Jalan Timah 2 Pasir Gudang Industrial Estate 81700 Pasir Gudang Johor, Malaysia Re : K993183 Powder-Free Latex Examination Gloves, Trade Name: Polymer Coated With Protein Content Labeling Claim (50 Micrograms or Less) Requlatory Class: I Product Code: LYY September 20, 1999 Dated: September 23, 1999 Received: Dear Mr. Sundaram: 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. ਬ 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 {1}------------------------------------------------ Page 2 - Mr. Sundaram the Federal Register. Please note: this response to your premarket notification 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. This letter will allow you to beqin 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 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 the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities 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.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski A. Ulatowski Timo Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo with a diamond shape. The top and bottom triangles of the diamond are shaded black with white lines. In the center of the diamond is a white oval with the words "QUALITY SYSTEM" in black letters. Below the diamond is the word "SIRIM" in black letters. QUALITY SYSTEM 0009 051 500 REGISTRATION NO 0400 ## AN-CENTURY RUBBER PRODUCTS SDN. BHD. Image /page/2/Picture/18 description: The image shows a logo with the letters 'PC' inside of a bulb-shaped border. The letters 'PC' are stylized with a wavy, textured appearance. The bulb-shaped border is thick and dark, with a slight indentation at the top, resembling the shape of a light bulb or a stylized onion. The logo has a vintage or retro feel due to its design and texture. Co. No: 168095 Lot No. 230, Jalan Timah 2, Pasir Gudang Industrial Estate, 81700 Pasir Gudang, Johor, Malaysia. Tel: +60-7-251 8551 / 251 0115 / 251 6537 Fax : +60-7-251 3481 ANNEUXRE 'A' OCTOBER 20,1999 GLOVE REVIEW SUMMARY K 993183 POWDER-FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) INDICATION FOR USE STATEMENT A patient examination glove is a disposable device intended for medical purposes 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) Qlus S. Lin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital I 510(k) Number _ Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Format 1-2-96)