FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES

{0}------------------------------------------------ ## OF HEALTH & HUMA's SERVICES DEPARTMEN : Image /page/0/Picture/1 description: The image contains a close-up of text that appears to read "Health Servi". Due to the image quality, the beginning of the text is cut off. The text is in a simple, sans-serif font and appears to be part of a larger document or sign. Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850 ## NOV 1 8 2002 Hartalega Sdn Bhd C/O Mr. Tito Aldape Microflex Corporation 2301 Robb Drive Reno. Nevada 89523 Re: K022671 Trade/Device Name: FreeForm Blue Powder Free Nitrile Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: September 30, 2002 Received: October 15, 2002 Dear Mr. Aldape: 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. Fxisting 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. Aldape Please be advised that FDA's issuance of a substantial equivalence determination docs 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html Sincerely vours, Valerie Cusack //foe Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ INDICATIONS FOR USE Applicant : HARTALEGA SDN. BHD. K022671 510(k) Number (if known) : Device Name : FreeForm Blue Powder Free Nitrile Examination Gloves Indications For Use : The nitrile examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) Sirch for Clari ivision Sidn-Off Division of Anesthesiology, General Hospital. Infection Control. Dental Devices KOJ267 510(k) Number ._