ALLIANCE RUBBER, EC-GRIP

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles facing to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856 OCT 21 1997 Mr. Chua Hooi Koon Alliance Rubber Products Sdn. Bhd. 878, Jalan Bandar Baru, Sungei Kecil, 14300 Nibong Tebal Pulau Pinang Malaysia K972801 Re : Alliance Rubber, EC-Grip Powdered Latex Trade Name: Examination Gloves With Protein Content Labeling Claim (200 Microgram or less) Regulatory Class: I Product Code: LYY September 20, 1997 Dated: September 26, 1999 ... ....... Received: Dear Mr. Koon: 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 requlations 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: {1}------------------------------------------------ Page 2 - Mr. Koon 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 emoduct 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 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}------------------------------------------------ Alliance Rubber Products Sdn.Bhd. 878, Jalan Bandar Baru, Sungei Kecil, 14300 Nibong Tebal, Pulau Pinang, Malaysia. Company No. : 52446-U Fax : (04)-5932262, 3322034 Tel : (04)-5932235, 5937616 Page :1/1 Date : 08-07-97 Our Ref :CHK/080797/5 Your Ref : ## ATTACHMENT 2 : ## INDICATION FOR USE Applicant : ALLIANCE RUBBER PRODUCTS SDN. BHD. K972801 510(k) Number (if known) : K896673- Device Name : LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAM OR LESS) Trade Name : (1) ALLIANCE RUBBER (2) EC-GRIP (3) Other clients private labelling Indication For Use : A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient. Concurrence of CDRH Office of Device Evaluation (ODE) --- (Division Sign-Off) Division of Dans and General H 510(k) Number Prescription Use Per 21 CFR 801.109 OR Over-The-Counter