STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with three curved lines above them, resembling a bird in flight. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR - 3 1999 Smart Glove Corporation (M) Sdn. Bhd. C/O Mr. Timothy F. Hand President Boston® Medical Corporation 12011 Guilford Road Annapolis Junction, Maryland 20701 K981947 Re : Sterile Powder-Free Nitrile Surgeons Gloves Trade Name: (natural, Blue and Green) Regulatory Class: I Product Code: KGO January 29, 1999 Dated: February 4, 1999 Received: Dear Mr. Hand 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 Existing major be subject to such additional controls. regulations 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 Manufacturinq Practice for Medical Devices: General (GMP) regulation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you miqht have under sections 531 through 542 of {1}------------------------------------------------ Page 2 - Mr. Hand 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}------------------------------------------------ 서 연합 K981947 INDICATIONS FOR USE ## SMART GLOVE CORPORATION SND BHD Applicant: MALAYSIA 510(k) Number (if known): 产 SURGEON'S GLOVE, STERILE - TYPE II Device Name: Indications for Use: A SURGEON'S GLOVE IS A DEVICE MADE OF NATURAL OR SYNTHETIC RUBBER INTENDED TO BE WORN BY OPERATING ROOM PERSONNEL TO PROTECT A SURGICAL WOUND FROM CONTAMINATION. ## . DO NOT WRITE BELOW THIS LINE - (FOR FDA USE ONLY) Concurrence of CDRH Office of Device Evaluation (ODE) Division Sign-Off (Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number Prescription Use Per 21 CFR 801.109 OR Over-The-Counter\$\sqrt{}\$