POWDER FREE NITRILE EXAMINATION GLOVES

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES SEP 6 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Chua Choon Chuan AR Alliance Healthcare Sdn. Bhd. 8, Lorong Industri 11, Kawasan Perindustrian Bukit Panchor 14300 Nibong Tebal, Pulau Pinang, MALAYSIA Re: K022619 Trade/Device Name: Powder Free Nitrile Examination Gloves, Blue Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: August 5, 2002 Received: August 7, 2002 Dear Mr. Chuan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. {1}------------------------------------------------ Page 2 -- Mr. Chuan You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 vours. Susan Runnos をTimothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## AR Alliance Healthcare Sdn.Bhd 8. Lorong Industri 11. Kawasan Perindustrian Bukit Panchor, 14300 Nibong Tebal, Pulau Pinang, Malaysia. Tel : (04)-5937616 Fax : (04)-5932262 email : arhealthcare@po.jaring.my Date : 01/08/2002 Page : 1/1 Our Ref : CCC/010802/04 ## ATTACHMENT 2 : ## INDICATION FOR USE Applicant : AR ALLIANCE HEALTHCARE SDN. BHD. K022619 510(k) Number (if known) : Device Name : POWDER FREE NITRILE EXAMINATION GLOVES, Blue Trade Name : (1) NITRI GRIP (2) Other clients private labeling 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 Anesthesiology, General Hospital Infection Control, Dental Devices OR Over-The-Counter Prescription Use Per 21 CFR 801.109