POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the three branches of government. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 0 3 2004 PT. Smart Glove Indonesia Mr. Foo Khon Pu Manager Director JL. Pelita Raya, No 5-7 Kawasan Industri Medan Star, JL Raya Medan-Lubuk Pakam KM. 19, TG Morawa- Deli Serdang Utara, INDONESIA 20362 Re: K040791 Trade/Device Name: Polymer Coated, Powder Free, Nitrile Examination Gloves, Blue Color Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: March 20, 2004 Received: March 29, 2004 Dear Mr. Pu: 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 mersate comments, 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 approvisions 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 (1 NET), It may of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announeements concerning your device in the Federal Register. {1}------------------------------------------------ ## Page 2 -Mr. Pu Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 315suance of a baseaux in the your device complies with other requirements mean that FDA has made a decommance and regulations administered by other Federal agencies. of the Act of ally I cochal statutes and regencessed and limited to: registration You music comply with an the Act STequilements) art 801); good manufacturing practice and listing (21 CFR Part 607), laborning (21 CFR Pat 820); and if 1 CFR Part 820); and if requirents as set form in the quality by stime (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) This letter will anow you to begin mading of substantial equivalence of your device to a premarket notification. The PDF miding of salessification 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), If you ucsite specific at rice for your se at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Diviber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Clus Chiu Lin. Ph.D Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Page 3 of 42 ## Indication for Use Statement: 3.0 ## INDICATION FOR USE | Applicant: | PT. SMART GLOVE INDONESIA | |----------------|---------------------------| | 510(k) Number: | Kc40791 | Polymer Coat, Powder Free, Nitrile Examination Gloves Device Name: Indication For Use: This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Ken Meley General Hospit 510(k) Number.__ Page 1 of