POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows a logo for the Department of Health. The logo is circular and contains the words "DEPARTMENT OF HEALTH" around the perimeter. In the center of the logo is a symbol that resembles three abstract human figures. DEC 7 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Clement K.K. Oon Executive Director Oon Corporation Resources (M) Sdn. Bhd. Lot 59, Senawang Industrial Estate 70450 Seremban, Negeri Sembilan Darul Khusus MALAYSIA K981917 Re : Powder-Free (Chlorinated) Latex Examination Trade Name: Gloves with Protein Content Labeling Claim (50 Micrograms Or Less) Regulatory Class: I LYY Product Code: October 14, 1998 Dated: October 21, 1998 Received: Dear Mr. Oon: 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, 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 reqistration, 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 {1}------------------------------------------------ Page 2 - Mr. Oon: through 542 of the Act for devices under the Electronic Product Radiation Control 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 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" (21CFR 807.97). Other qeneral 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/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 {2}------------------------------------------------ Applicant: __ OON_CORP_RESQURCES_(M)_SUN_BU1_ 510(k) Number (if known): CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT Device Name: Device Name. - Gibbeling CARDERING (50 MICROGRAMS OR LESS) IS A PATIENT EXAMINATION GLOVE WHICH IS A DISPOSABLE MEDICAL DEVICE INTENDED FOR MEDICAL PURPOSES THAT ARE WORN ON THE EXAMINER'S HAND 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) Prescription Usc Per 21 CFR 801.109 (Optional Format 1-2-96) OR Over-The-Counter Olin S. Lin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number