POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol of three abstract shapes that resemble human figures. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Kenny Hoe Kok Seong General Manager HL Rubber Industries Sdn. Bhd. Lot 10, Kawasan Perindustrian Dioh 72000 Kuala Pilah Negeri Sembilan MALAYSIA ## 8 2007 FEB Re: K063522 Trade/Device Name: Powdered Patient Nitrile Examination Gloves (White/Blue Color) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 18, 2007 Received: January 22, 2007 Dear Mr. Seong: 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. Seong 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 modi that 1 DA mas may Federal statutes and regulations administered by other Federal agencies. or the Fet of all , I out a I 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 fishing (21 cost torth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in als quadistion 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) Prins reter notification. The FDA finding of substantial equivalence of your device to a premainer lettribution on 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 desire specific at no 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 overn of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Swen Ruppre 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}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo with the letters "HLRI" in a stylized font. The letters are horizontally aligned and have a three-dimensional appearance with a double-lined border. Behind the letters, there are two overlapping oval shapes that create a sense of depth and movement. The logo is black and white, giving it a clean and professional look. ## HL RUBBER INDUSTRIES SDN BHD (621188-H) ## INDICATION FOR USE STATEMENT : HL RUBBER INDUSTRIES SDN BHD Applicant : K063522 510K Number (if known) : Powdered Patient Nitrile Device Name Examination gloves (White / Blue color) : Indications for use A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination betwen patient and examiner. (PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH office of Device Evaluation (ODE) Shule R. Murphy, MD K063522 1 I Prescription use Per 21 CFR 801.109 OR Over-The-Counter