REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE

{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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY | | 1998 Mr. Neil Anderson, RAC Director of Regulatory Affairs, U.S. Operations London International Group, Incorporated 2926 Columbia Hiqhway Dothan, Alabama 36303 Re : K980942 Regent Biogel Indicator Inner Surgical Glove Trade Name: Regulatory Class: I Product Code: KGO March 11, 1998 Dated: March 12, 1998 Received: Dear Mr. Anderson: 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 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 (Premarket Approval) ; `it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ 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 the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of {1}------------------------------------------------ Page 2 - Mr. Anderson 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.fdaggov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski 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}------------------------------------------------ ## APPENDIX II ## Indications for Use Applicant - London International Group (Regent Medical) 510(K) Number (if known) K980942 Device Name - Sterile Indicator Inner Surgeon's Glove Indications for use: A Sterile surgeon's Glove is worn on the hand of a Surgeon or similar health care person, to prevent contamination between health care providers and the patient during invasive surgical or similar procedures. ## Concurrence of CDRH Office of Device Evaluation | (Division Sign-Off) | George A. Mills for Qin Jin PhD | |----------------------------------------|---------------------------------| | Division of Dental, Infection Control, | | | and General Hospital Devices | | 510(k) Number_________________________________________________________________________________________________________________________________________________________________ Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over the Counter _____________________________________________________________________________________________________________________________________________________________ OR ・・ Per 21 CFR 801.109