MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three overlapping human profiles facing to the right, with flowing lines suggesting movement or progress. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV - 6 1997 Mr. Azman Ismail Production Manager PWA Industries Sdn. Bhd. BATU 15-1/2, Sungai Pelong Sungai Buloh, Selangor, D.E. Malaysia Re : K973551 Medi-Plus, Health-Plus, Sanitex, Reliance Trade Name: Powder-Free Blue Nitrile Examination Gloves Regulatory Class: I Product Code: LZY September 15, 1997 Dated: August 21, 1997 Received: Dear Mr. Ismail: 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 aqainst 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 requirement, 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 requlation 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 {1}------------------------------------------------ Page 2 - Mr. Ismail 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 requlations. This letter will allow you to begin marketing your dewice 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. Time Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known): Device Name: Powderfree, Blue Nitrile Examination Glove Indications For Use: 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 ANDITHER PACE (F NEEDED) (CONTRACT PART 1 CODU Office of Device Evaluation (ODE) Concurence of CDRH , Office of Device Evaluation (ODE) OR Rhin S. Lahn (Division Sign-On Division of Dont and General Ho 510(k) Numbe Prescription Use-(Pa 21 Cr3 801.105) Over-The-Course (1se Optiogal Forms I-2-95) ... ..