GUTHRIE PRIME POWDER-FREE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 9 1999 Guthrie Medicare Products (NS) Sdn. Bhd. C/O Ms. Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021 Re : K990228 Guthrie Prime Powder-Free Latex Examination Trade Name: Gloves with 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulatory Class: I Product Code: LYY Dated: January 20, 1999 Received: January 25, 1999 Dear Ms. Goldstein-Falk We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of {1}------------------------------------------------ Paqe 2 - Ms. Goldstein-Falk the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ mdi Consultants, Inc. Attachment #1 ت Page of 1 ## K 990228 SIO(K) NUMBER (IF KNOWN) : CATEX Powder-Free (Polymer Coated) Patient Examination Gloves DEVICE NAME: 50 magm OR less of fotal water ary First gloves contain INDICATIONS FOR USE: Powder-free Patient Examination glove is a disposable device which is primarily Powder-free Patient Examination 'giove is a examiner's hand or finger to prevent Intended for modition 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 Qiu S. Lin (Division Sign-Off) (Division Sign-Ont) Division of Dental, Infection Control, Division of Dental, Devices Division of Hospital De 510(k) Number Page 5 ত্রী c