POWDERED LATEX SURGEON'S GLOVE

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image is a circular seal for the Department of Health and Human Services (HHS) in the USA. The seal features the department's logo, which is a stylized depiction of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged around the logo in a circular fashion. The text is in all capital letters and is evenly spaced around the circle. SEP 1 2 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Anan Jetsadawisut Managing Director Shun Thai Rubber Gloves Industry (P) Company Limited 9 Moo 4, Kached, Muang, Rayong 21110 THAILAND Re: K052031 Trade/Device Name: Powdered Latex Surgeon's Glove with Protein Content Labeling Claim (200 Micrograms or Less per Gram) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: July 15, 2005 Received: August 5, 2005 Dear Mr. Jetsadawisut: 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 NE ), I and 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. Jetsadawisut 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 mean that I Driving and regulations administered by other Federal agencies. or the Act of any I outeral title Act's requirements, including, but not limited to: registration r od intilet compry mint 807); labeling (21 CFR Part 801); good manufacturing practice and instills (s as set forth in the quality systems (QS) regulation (21 CFK Part 820); and if applicable, the electronic product radiation control provisions (Sections כ31-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) rms feter 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), rf you donto the Office of 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 over 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, 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 STATEMENT ### APPLICANT: Shun Thai Rubber Gloves Industry Public Company, Ltd. ## 510(k) NUMBER (if known): K052031 #### DEVICE NAME: POWDERED LATEX SURGEON'S GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS PER GRAM) ### Indications For Use: The powdered latex surgeon's glove with protein content labeling claim (200 micrograms or less per gram) is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between patient and operating room personnel. Prescription Use ... ................... Per 21 CFR 801.109 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) Revised 9-9-05 Jenna Mucker Sheila H. Murphy, MD 1/12, (Division Sign-Off) EXHIBIT A Division of Anesthesiology, General Hospital. Infection Control, Dental Devices 510(k) Number: K052031