STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 2 7 2006 Mr. Lim L. Bung Executive Director Ware Safe Malaysia Sdn. Bhd. Lot 1, Leboh Hishamuddin Satu, North Klang Straits Industrial Area Port Klang, Selangor, D.E., Malaysia 42000 Re: K062778 Trade/Device Name: Sterile Powder-Free Nitrile Patient Examination Glove, Blue Non-Sterile Powder-Free Nitrile Patient Examination Glove, Blue Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: September 12, 2006 Received: September 18, 2006 Dear Mr. Bung: 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. Bung 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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 requirements as set forth in 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), please contact 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/cdrh/industry/support/index.html. Sincerely yours. Susan Dunne 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}------------------------------------------------ ## Indication for Use K062778 510 (K) Number(If known): Device Name: Sterile Powder-free Nitrile Patient Examination Glove, Blue Colored, Indication For Use: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Prescription Use (Part 21 CFR 801 Subpart D) AND / OR Over-The-Counter Use (21 CFR 801 Subpart C) Image /page/2/Picture/10 description: The image shows a check mark above a horizontal line. The check mark is slightly tilted to the left. The horizontal line is straight and positioned below the check mark. The check mark and the line are both black. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Shada A Murphy, MD (Division Sign-Off) (Division Sign-Om) Division of Anesthesiology, General Hospital Infection Control, Demal Devi 510(k) Number: Page 1 of 1 {3}------------------------------------------------ ## Indication for Use K062778 510 (K) Number(If known): Device Name: Non-sterile Powder-free Nitrile Patient Examination Glove, Blue Colored, Indication For Use: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Prescription Use (Part 21 CFR 801 Subpart D) AND / OR Over-The-Counter Use (21 CFR 801 Subpart C) Image /page/3/Picture/10 description: The image contains a check mark above a horizontal line. The check mark is black and appears to be handwritten. The horizontal line is also black and is located directly below the check mark. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Shuly A. Murphy, Ph.D. (Division Sign-Off) 10/27/04 on of Anesthesiology, General H on Control, Dental Devic 510(k) Number: K062278 Page 1 of 1