DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. MAR 0 5 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Creative Contract (M) Sdn. Bhd. C/O Mr. Mark Reiber Innovative Healthcare Corporation 8220 Charles Page Boulevard Sand Springs. Oklahoma 74063 Re: K021546 Trade/Device Name: DermAssist™ Fluid Resistant Surgical Mask (Tie On Style) with WrapAround Visor / Procedure Mask (Ear Loop Style) with WrapAround Visor Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: January 2, 2003 Received: January 8, 2003 Dear Mr. Reiber: 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. Existing major regulations affecting vour 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. Reiber Please be advised that FDA's issuance of a substantial equivalence determination does 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act 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 yours, Susan Rinner Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## 510 (k) Number: K 021546 Device Name: DermAssist ™ Fluid Resistant Surgical Mask (Tie On Style) with WrapAround Visor / Procedure Mask (Ear Loop Style) with WrapAround Visor Indication For Use: DermAssist ™ Fluid Resistant Surgical Mask / Procedure Mask with WrapAround Visor is a high filtration 4 ply face mask is intended to be worn by an operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms body fluids and particulate materials. The WrapAround Visor is a 3M ® Anti Fogging Visor, is intended to act as a face shield or an eye shield, during instances where blood and bodily fluids may be splashed upon the surgeon or medical healthcare personnel. Concurrence of CDRH, Office of Device Evaluation (ODE) OR Prescription Use Over-The-Counter Use (Per 21 CFR 801.109) Qlin S. lin General Hospital of Anesthesiolog Control, De 510(k) Number: K021546