POWDERED LATEX PATIENT EXAMINATION GLOVES

{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 depiction of an eagle with three wing-like shapes. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle symbol. Public Health Service JUL 1 2 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 P.T. Anlis Abadi Internasional c/o Mr. Huan-Chung Li Shinemound Enterprise Incorporated 17A Sterling Road North Billerica, Massachusetts 01862 Re: K051465 Trade/Device Name: Powdered Latex Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: April 20, 2005 Received: June 03, 2005 Dear Mr Li: We have reviewed your Section 510(k) premarket notification of intent to market the device indicati We have reviewed your Section > ro(x) prematice is substantially equivalent (for the indications felerenced above and nave uctoringed live arketed predicate devices marketed in interstate for use stated in the enclosure) to regars mant date of the Medical Device Amendments, or to commerce prior to May 28, 1776, the enateriance with the provisions of the Federal Food, Drug. devices that have been recaired in accerative while and while and of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarke and Cosment Act (Act) that do not require appro the general controls provisions of the Act. The You may, therefore, thanket the device, basyon to the most for annual registration, listing of general controls provisions of the rist 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 il your device is classified (500 above) into existing major regulations affecting your device can may be subject to such additional controlls. Existing and to 898. In addition, FDA may be found in the Oous of concerning your device in the Federal Register. {1}------------------------------------------------ ## Page 2 - Mr. Li Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a bevice complies with other requirements of the Act that FDA has made a decormination an administered by other Federal agencies. You must or any rederal statutes and regaranents, including, but not limited to: registration and listing (21 comply with an the Act 3 requirements) and manufacturing practice requirements as set CFK Fart 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decises vor device as described in your Section 510(k) I his letter will anow you to ogen mailioning of substantial equivalence of your device to a legally premarket nothleadon. The PDA maing of basification 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 If you desire specific advice for your ac 1100 %. Also, please note the regulation entitled, processes of a V contact the Office of Comphalled at (210) and Station" (21CFR Part 807.97). You may obtain " Misoranding by reference to promanto notificas with as the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Auy Sylvom for 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}------------------------------------------------ ## Attachment B ## INDICATION FOR USE Anwar Firman, P.T. ANLiS INTERNASiONAL. Applicant: 510K Number (if known): * K051465 Device Name: Powdered Latex 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. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Per 21 CFR 801.109 (Optional Format 1-2-96) OR Over – The- Counter Use _X * For a new submission, do NOT fill in the 510(K) number blank. Shula R. Murphy, 15 alogy, General Hospital, 510(K) V