SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of three human figures. ## AUG 1 6 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Sunmax Enterprises Shanghai Company Limited C/O Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021 K011765 Re : Sunmax Blue Nitrile Powder Free Trade/Device Name: Examination Glove Regulation Number: 880.6250 Requlatory Class: I Product Code: LZA Dated: June 5, 2001 Received: June 7, 2001 Dear Ms. Falk: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. {1}------------------------------------------------ Page 2 - Ms. Falk concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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, Antone Ciceretti // for Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## SUNMAX ENTERRPISE SHANGHAI CO.,LTD Image /page/2/Picture/1 description: The image shows a logo with a stylized handprint forming a circle. Inside the handprint, there are lines representing fingers. To the right of the handprint, there are three small circles arranged vertically. Below the handprint, the word "Maslaa" is written in a stylized font. The Vangard of Vinyl Gloves No.2 New Industrial Area, Zhu Hang Zhen, Jin Shan County, Shanghal, China TEL: (886) 2 2713 6677 FAX: (886) 2 2546 2480 April 20'0. 2001 INDICATIONS FOR USE STATEMENT of 510(k) Number (if known): KO 11765 Examination Device Name Sunmax Blue Nitrile Powderfree Glove Indications For Use:A powderfree patient examination glove is a disposable device that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. . Alex Lee President SUNMAX ENTERPRISE SHANGHAI CO., LTD (PLEASE OO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use Prescription Use (Optional Format 09 (Per 21 CFR 801.109) Clins S. Lim (Division Sign ! Division of D --- : Infection Control, and General Fiosp 510(k) Number