GREAT GLOVE POWDERED VINYL EXAMINATION GLOVES

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. Public Health Service DEC 2 0 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. K.M. Lee Executive Director Great Glove (China) Incorporated 3-4 Floor, No.16 Hua Chang Road Jiangsu 215600, Zhangjiagang CHINA Re: K052922 Trade/Device Name: Powdered Vinyl Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 7, 2005 Received: December 13, 2005 Dear Mr. Lee: 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 approvisions 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 (1 Writ), it hay ob back 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. Lee Please be advised that FDA's issuance of a substantial equivalence determination does not I lease of advisod that 127 to leasiness on that your device complies with other requirements moun that I DAT has made a actes and regulations administered by other Federal agencies. or the Act of any vouth all the Act's requirements, including, but not limited to: registration 1 od intine (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fiscing (21 et read on the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quartify ajon 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) This letter while are in J The FDA finding of substantial equivalence of your device to a premaired predicated. - 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), 11 you desire specific acerof 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 may obtain 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, Syrtie y. Michie Omd. 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K052922 Device Name: Powdered Vinyl Examination Glove a manager and the comments of the comments of the comments of the comments of the comments of the comments of the former of the former of the former of the former of the form Indications For Use: A patient examination Vinyl Powdered Gloves is a disposable A patient chamilable medical purpose that is worn on the device Intended for media. Contamination between patient and examiner. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Shula H. Murray D 12/20/05 School, Dental Devices K-052922 Page 1 of __