NITRILE POWDER FREE EXAMINATION GLOVES

{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 emblem, which is a stylized depiction of an eagle or bird in flight, composed of three curved lines. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 9 1999 Mr. Chong Yoon Tat Director Cranberry (M) Sdn. Bhd. Lot 85, Jalan Portland Tasek Industrial Estate 31400 Ipoh, Perak Darul Ridzuan MALAYSIA Re : K983334 Nitrile Powder-Free Examination Gloves Trade Name: Requlatory Class: I Product Code: LZA Dated: January 15, 1999 January 19, 1999 Received: Dear Mr. Chong Yoon Tat 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 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 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 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 {1}------------------------------------------------ Page 2 - Mr. Chong Yoon Tat the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA findinq 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 requlation 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 Director 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 black and white drawing of an acorn. The acorn is inside of a square. The acorn is facing towards the upper right corner of the square. CRANBERRY (M) SDN. BHD. (104994 - w9 (A MEMBER OF THE YEE LEE GROUP) Lot 85, Jalan Portland, Tasek Industrial Estate, 31400 Ipoh, Perak Darul Ridzuan, Malaysia. Cor 60, 005 1055 / 546 1055 Fax: (05) 547 3962 / 547 9862 Telex: YLOIL MA 44556 Applicant : CRANBERRY (M) SDN. BHD. LOT 85, JALAN PORTLAND, TASEK INDUSTRIAL ESTATE, 31400, IPOH, PERAK, MALAYSIA 510(k) Number (if known): \$983334 Device Name: Nitrile Powder Free Examination Glove - Cranberry Indications For Use: This product is a patient examination glove. It is a disposable device intended for medical purposes that is 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) OR Concurrence of CDRH, Office of Device Evaluation (ODE) Chiu S. Lin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number Prescription Use (Per 21 CFR 801.109) Over-The-Counter-Use X