POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The caduceus is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in all capital letters. The logo is simple and uses a black and white color scheme. Public Health Service AUG 1 - 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Shen Wei (USA), Incorporated c/o Mr. Stanley Duan 33278 Central Avenue, #102 Union City, California 94587 Re: K051683 Trade/Device Name: Powder-Free Synthetic Vinyl Exam Gloves With Vitamin E Coating Regulation Number: 21CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: May 21, 2005 Received: June 23, 2005 Dear Mr. Duan: 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 your 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. Duan Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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 (OS) 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 (240) 276-0115. 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/industry/support/index.html. Sincerely yours, 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}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo with the word "Wei" in bold, black letters. Above the word "Wei" is a graphic of what appears to be a tree. To the right of "Wei" is the text "usa inc." Shen Wei (USA) Inc. 33278 Central Ave. #102. Union City, CA 94587 Tel: 510-429-8692 Fox: 510-487-5347 ## Attachment Two ## INDICATION FOR USE Shen Wei (USA) Inc. Applicant: Powder-Free Synthetic Vinyl Exam Gloves with Vitamin E coating Device Name: ## Indication for Use: A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250) Prescription Use (Per 21CFR 801 Subpart D) AND/OR Over the Counter Y (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) Division of Anesthesiology, General Hospital, Infection Control, Dental Device 510(k) Number. K051683