NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR

{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 a stylized image of a human figure with three flowing lines representing the body, head, and arms. The figure is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 7 2003 Mr. Foo Khon Pu Pt. Smart Glove Indonesia Jl. Pelita Raya No. 5 - 7 Kawasan Industri Medan Star Jl. Raya Medan, Lubuk Pakam Km. 19. Tg Marowa B-Tg. Marowa Deli Serdang, 20362 Sumatera Utara, INDONESIA Re: K030406 Trade/Device Name: Powder Free Nitrile Examination Gloves with Peppermint Flavor Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: January 31, 2003 Received: February 3, 2003 Dear Mr. Khon 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 Amendments, 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 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 – Mr. Khon Pu Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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), please contact the Office of Compliance 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Susan Runyon Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## GLOVE INDONESIA Page 3 of 39 ## 3.0 Indication for Use Statement: ## INDICATION FOR USE | Applicant: | PT. SMART GLOVE INDONESIA | |----------------------------|---------------------------------------------------------------| | 510(k) Number: Applied for | K030406 | | Device Name: | Powder Free Nitrile Examination Gloves with Peppermint Flavor | ## Indication For Use: This glove is disposable and intended for medical purpose that is ============================================================================================================ hand to prevent contamination between patient and examiner. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office Of Device Evaluation (ODE) Prescription Use Per 21 CFR 801.109 OR Over-The-Counter (Optional i ormat 1-2-96) Qilin S. Lahn (Division Sign-Off) Division of Anesthesiology, Infection Control, D 510(k) Number. K 030406