POWDER FREE STERILE LATEX SURGICAL GLOVES

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES 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 department's name around the perimeter. In the center of the seal is an abstract image of an eagle with three stylized wing feathers. Public Health Service DEC 9 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Nurul Aisyah Kong Ouality Assurance Manager Hartalega SDN.BHD. 9, Jalan Kuang Bulan, Taman Kepong Industrial Estate, 52100 Kuala Lumpur, MALAYSIA Re: K052177 Trade/Device Name: Powder Free Sterile Latex Surgical Gloves-Polymer Coated (with Protein Labeling Claim) Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: November 19, 2005 Received: November 30, 2005 Dear Ms. Kong: 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 Amerade ents, 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. ff 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 Nr.), it may ob such of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register. {1}------------------------------------------------ ## Page 2 -Ms. Kong Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be ad ribed and a determination that your device complies with other requirements moan that 1 Dr mas mass statutes and regulations administered by other Federal agencies. or the ret or any with 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 1 forth in the quality systems (QS) regulation (21 CFR Part 820); and if roquisents to be rectronic 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), n you don't 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 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/cdrlv/industry/support/index.html. Sincerely yours, Sanette Y Michael Dmd 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}------------------------------------------------ Indication For Use 510(k) Number (if known): ¥ CC 2 (၂၇ 2 Device Name: Powder Free Sterile Latex Surgical Gloves - Polymer Coated (With Protein Labeling Claim) Indications for Use: ﺴﻨﺔ ﺍﻟﻤﺘﻨﺸﻴ A Powder Free Surgeon's Glove is intended to be worn on the hands, usually in surgical settings to provide a barrier against potentially infectious materials and other contaminants. Prescription Use (Part 21 CFR 801 Subpart D) OR Over-The-Counter Use __x______________________________________________________________________________________________________________________________________________________ (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 K. Kingsley by 12/8/05 Control, Dental Diseases K052177 Page 1 of