DISPOSABLE 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT - 4 2001 Shijiazhuang Brilliance Plastic Company Limited C/O Mr. Huan Chung-Li Vice President Shinemound Enterprise, Incorporated 17A Sterling Road North Billerica, Massachusetts 01862 Re: K012710 Trade/Device Name: Disposable Powdered Vinyl Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: June 8, 2001 Received: August 14, 2001 Dear Mr. Chung-Li: 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. 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. Chung-Li of the Act or any Federal statutes and regulations administered by other Federal agencies. or use or any - outh 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 and insting (21 CF t t t t t t t t t t t 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, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ Attachment G ## INDICATION FOR USE Feng Lian Fa, Shijiazhuang Brilliance Plastic Co., LTD Applicant: * KO12710 510K. Number (if known): Device Name: Prepowdered Vinvl Patient Examination Gloves Indication For Use: A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Sincerely yours, 拮联法 Feng Lian Fa President (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | |--------------------------------------------------------| |--------------------------------------------------------| *Olin S. Lin* | (Division Sign-Off) | | |---------------------------------------------------------------------|---------| | Division of Dental, Infection Control, and General Hospital Devices | | | 510(k) Number | K012710 | | Prescription Use<br>Per 21 CFR 801.109<br>(Optional Format 1-2-96) | OR | Over-The Counter Use | |--------------------------------------------------------------------|----|----------------------| |--------------------------------------------------------------------|----|----------------------| * For a new submission, do NOT fill in the 510(K) number blank