COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION GLOVE (PINK, BLUE, GREEN AND VIOLET)

{0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health and Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus with three snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the logo. ## JUN 2 3 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Tan Peng Hock Managing Director Glovco (M) SDN BHD Lot 760, Jalan Haji Sirat, 42100 Klang, Selangor Darul Ehsan, MALAYSIA Re: K051345 Trade/Device Name: Colored Powder Free and Polymer Coated Patient Examination Glove (Pink, Blue, Green and Violet ) With A Protein Claim Of Less Than 50 µg/gm Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: May 5, 2005 Received: June 1, 2005 Dear Mr. Hock: 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. Hock Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvrsod that 1-27 - 16 lestains on that your device complies with other requirements mean that IDA nas made a decembers and regulations administered by other Federal agencies. of the Act of ally I edelar statutes and registered to: registration 1 ou must comply with an an an an any (21 CFR Part 801); good manufacturing practice allo listing (21 CF re Part 807), abouting systems (QS) regulation (21 CFR Part 820); and if requirements as set forth in all quadiation 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) I mis icter will anow your e oogle and of substantial equivalence of your device to a premits in the motion. The PDF 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), II you ucsile specific advise for your 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 other general manufacturers, International and Consumer Assistance at its toll-free Division of 01 01 01 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Syvette Y. Michaud m.d. 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}------------------------------------------------ ## Indications For Use K051345 510(k) Number. Colored Powder Free And Polymer Ceated Patient Examination Device Name: Glove (Pink, Blue, Green and Violet) With A Protein Claim Of Less Than 50 pargm Glove. A colored, powder free and polymer opated patient examination glove is Indications For Use: a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be wom on the hands or finger(s) for medical purposes to provide a bantier against potentially mlectious materials and other contaminants. The colors, pink, blue, green and violet are added respectively to the latex in the production process for the intended colored glove. Prescription Use NO AND/OR Over-The-Counter Use YES (21 CFR 801 Subpan C) Shula A. Murphy, R. (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number. K051345