NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)

{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 stylized eagle with three lines forming its body and wings. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 6 2005 Mr. Kuan Eu Jin Quality Management Representative Hartalega Sdn. Bhd. Lot 9, Jalan Kuang Bulan, Taman Kepong Industrial Estate, 52100 Kuala Lumpur MALAYSIA Re: K050214 K05021 1 Trade/Device Name: Nitrile Powder Free Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: 1 Product Code: LZA Dated: February 23, 2005 Received: March 9, 2005 Dear Mr. Eu Jin: We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your because as a see 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 micrsuit commerce prior to may 20, been reclassified in accordance with the provisions of Amendinone, or to ac novelic Act (Act) that do not require approval of a premarket the Federal 1 000, Drag, and Ooou may, therefore, market the device, subject to the general approval uppression (the Act. The general controls provisions of the Act include controls provisions or a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Wry), it may of badyson to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be foundsh further announcements concerning your device in the Federal Register. {1}------------------------------------------------ ## Page 2 – Mr. Eu Jin Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA \$ Issualice of a substantials with other requirements mean that FDA has made a determination that your devices with other Federal agencies mean that FDA nas made a decemination and your and your and more of ther Federal agencies. of the Act or any Federal statutes and regulations administered by registration of the Act or any rederal statues and regirements, including, but not limited to: registration You must comply with all the Act 's requirement monufacturing practice You must comply with an the Act s requirements; int 801); good manufacturing practice and listing (21 CFR Part 807); labeling (21 CFR Part 801); and i and listing (21 CFR Part 807), labeling (21 OFF Creen (05) , g-612 , CFR Part 820); and if requirements as set forth in the quality systems (QS) regulation (21 , 542 , of the requirements as set form in the quality systems (QD) regariation (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) This letter will anow you to begin matically your ence of your device to a premarket nothreation. The PDA miams or subscribes 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), If you desire specific advice for your de riso at (240) 276-0115. Also, please note the regulation Please contact the Office of Compliance at (240) 276-0115. Also, please n prease contact inc Other or Comphanies are =================================================================================================================================== may obtain other general information on your responsibilities under the Act from the may obtain other general miormational and Consumer Assistance at its toll-free Division of Birman (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 510(k) Number (if known) : K050214 Device Name : Nitrile Powder Free Examination Gloves Indications For Use : The nitrile examination gloves is a disposable device intended for medical 1 ne nerne purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Prescription Use (Part 21 CFR 801 Subpart D) × Over-The-Counter Use OR (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) Qur ි on of Anealtiesiclegy. General Hospit.is cion Control, Dental Devices A050214 Page 1 of |