Hi Coat Powder Free Latex Patient Examination Gloves

{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 of three human profiles facing to the right, represented by curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. A. Hendra Ramali ·President Director P.T. Latexindo Tobaperkasa Jalan Raya Binjai Km. 11 Medan 20128, Indonesia NOV 1 8 1997 K972539 Re : Trade Name: Hi Coat Powder-Free Latex Patient Examination Gloves Requlatory Class: I Product Code: LYY Dated: October 28, 1997 Received: November 3, 1997 Dear Ms. Ramali: 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 abe Beaced in the eny 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 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 regulation (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 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 {1}------------------------------------------------ Page 2 - Ms. Ramali 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 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 requlation (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, K. Aldrich Time Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health Enclosure . 5 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the text "P.T. LATEXINDO TOBAPERKASA" in a bold, outlined font. The text is arranged horizontally, with each word clearly separated. A thin line is present underneath the text, adding a subtle emphasis to the words above. Jalan Raya Binjai Km. 11, Medan - Indonesia, Phone/Fax. : (62 - 61) 851410gtf8fffffent 1 ## Indication For Use Statement 912539 510(K) Number (if known) : Device Name : Powder Free Latex Patient Examination Gloves Indication For Use : A Medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. PT. Latexindo Tobaperkasa Hendra Ramali President Director (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (Division Sign-Off) Division of Dental, Infection Control, Cicci and General Hospital Defencurrence of CDRH, Office of Device Evaluation (ODE 510/k) Number __ - 60 97753 Over-The-Counter Use Prescription Use Or (Per 21 CFR 801.109) (Optimal Format 1-2-96)