SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The bird is oriented towards the upper right of the image. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## FEB 2 6 2002 Mr. Tan Swu Choon Deputy General Manager Syntex Healthcare Product Company Limited No. 1, Fanjiazhung Industrial Zone Xinji City, Hebei Province P. R CHINA 0552360 Re: K020493 Trade/Device Name: Syntex Powder-Free Nitrile Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: February 9, 2002 Received: February 13, 2002 Dear Mr. Choon: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amenditens, or to do 11000 and Cosmetic Act (Act) that do not require approval of a premarket the Federal F ou, Drag, and Coou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include contrements 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 MI , I ria) 80 subject , 11 . your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device of . may publish further announcements concerning your device in the Federal Register. 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 {1}------------------------------------------------ ## Page 2 - Mr. Choon of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I oderal business requirements, including, but not limited to: registration 1 out must comply with and the Proofing (21 CFR Part 801); good manufacturing practice alle listing (21 OF RT rat 807), abolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in als quadistion 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 I mis tetter will and w you to organ in and inding 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 If you desire specific ad 1100 for in vitro diagnostic devices), please contact the alle additionally 21 CP1 (301) 594-4618. Additionally, for questions on the promotion and Office of Colliphiance are, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under notheation (21 OF ICP at 2007 the Division of Small Manufacturers, International and ule Act may of occamed in 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 Runo Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ 510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________ Tree Nitrile Examination Glove Device Name Indication For Use : A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over The Counter Use Prescription Use: (Per 21 CFR 801.109) (Optional Format 1-2-95) Sum Ruar ("Division Sign-Off) Chision of Denral Into Kocayh3