NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## FEB 1 4 2002 Formosa Glove Industrial Company Limited C/O Dr. Tiang S. Chang 1016 Seward Avenue Westfield, New Jersey 07090 Re: K014285 Trade/Device Name: Nitrile Patient Examination Gloves, Powder-Free, Purple Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: December 22, 2001 Received: December 27, 2001 Dear Dr. Chang: We have reviewed your Section 510(k) premarket notification of intent to market the device would bove 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 Interstate conmisered proces that have been reclassified in accordance with the provisions of Amendinents, or to act 1000 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 controls process 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 Nr.), it hay of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device oan over bublish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Time h A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ Image /page/2/Picture/0 description: The image is a black and white drawing of a hand that is shaped like a bird. The thumb of the hand forms the head and beak of the bird. The fingers of the hand form the wings of the bird. The palm of the hand forms the body of the bird. Indications for Use Formosa Glove Industrial Co., Ltd. Applicant: KO14285 510(k) Number (if known): Purple Nitrile Patient Examination Glove, Powder-free Device Name: Indications for Use: A patient examination glove is a disposable device intended for medical purposes that is A patient exammation glove is a career 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 Use hin-Ya Road, Cheng-Ch hinet.net alwan (Optional Format 1-2-96) Clim S. Lim mion Sign-Off) of Dental, Infection Contra FACTORY:N0.10-8,MA-KUO-LI,MATOU TOWN,TAINAN HSIEN,TAIWAN,R.O.C. 11 . 1061570-1885-6 FAX 1061570 - 1388