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

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 2 9 1999 Mr. Shukur Hasran QA/QC Officer Biografik (Malaysia) Sdn. Bhd. PT No. 3307 Jalan AM 1 Arab-Malaysian Industrial Park 71800 Nilai, Negeri Semblian DK, Malaysia Re : K ਕੇ ਕੇ 3 ਦੇ 2 ਕ Trade Name: Powder Free Latex Examination Gloves, Polymer Coated With Protein Content Labeling Claim (50 Micrograms or Less) Regulatory Class: I Product Code: LYY Dated: October 12, 1999 Received: October 18, 1999 Dear Mr. Hasran: 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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 {1}------------------------------------------------ #### Page: 2 -Mr. Hasran the Federal Register. Please note: this response to your : remarket notification submission does 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 regulations. 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) 594-4692. 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" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be oblained 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, Liesel W. Sheppard form 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}------------------------------------------------ #### ATTACHMENT 2 ### INDICATION FOR USE STATEMENT | Applicant | Biografik (Malaysia) Sdn Bhd | |---------------|-------------------------------------------------------------------------------------------------------------------------------| | 510(K) | K993529 | | Device Name : | Powder Free Latex Examination Gloves, Non-Sterile, Polymer Coated WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Indication for use A patient examination glove is worn on the hand of healthcare and similar personnel to prevent containination between healthcare personnel and the patient # PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) ## Concurrence of SDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) ଠାର Over-The-Counter V Sanuteeum for Chuchin (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dey 510(k) Number _