POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN - 5 1998 Mr. Hendra Ramali President Director P.T. Latexindo Tobaperkasa Jalan Raya Binjai Km. 11 Medan 20128, Indonesia Re: K974443 Trade Name: Powdered Free Nitrile Examination Gloves (Polymer Coated) Regulatory Class: I Product Code: LZY Dated: November 25, 1997 Received: November 25, 1997 Dear Mr. 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 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 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 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 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 - Mr. Ramali 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) 594-4618. 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, 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} P.T. LATEXINDO TOBAPERKASA Jalan Raya Binjai Km. 11, Medan 20128, Indonesia Tel. (6261) 851410 / 861471 / 868856 Fax. (6261) 851409 E-mail: ltxindo@indo.net.id Attachment I ## Indication For Use Statement 510(K) Number (if known): **K974443** Device Name: **Powder Free Nitrile Examination Gloves (Polymer Coated)** 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 *(Handwritten signature)* Hendra Ramali President Director *(Handwritten signature)* (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) *(Division Sign-Off)* *(Handwritten: "George A. Mello for Chief S. Tini, PhD")* Division of Dental, Infection Control, and General Hospital Service Office of Device Evaluation (ODE) 510(K) Number: **K974443** Prescription Use ☐ or Over-The-Counter Use ☑ (Per 21 CFR 801.109) (Optimal Format 1-2-96)