EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Exact Medical Manufacturing, Inc. The logo consists of the letters "EMM" in bold, black font, with the company name written in a smaller font size underneath. To the left of the text is a geometric design that is partially shaded. 101593 ## эс. 6: 510(k) Summary -- EMM Surgical Gown SMS w/PE Layer .Page Technological Characteristics Exact Medical Manufacturing Surgical Gown SMS w/PE Layer has the same design, material and performance characteristics of the predicate device. Summary of Testing Exact Medical Manufacturing Surgical Gown SMS w/PE Layer is substantially equivalent and meets the same acceptance criteria as the predicate device/gown in K023117. Non-clinical performance testing includes: Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with the methods of ISO 10993, Barrier properties- AAMI PB:70 Level 3, tensile, tear strength, flammability, linting and sterility. All results of the testing met acceptance criteria. Substantial Equivalence The surgical gowns described in this 510(k) submission are substantially equivalent in all specifications and performance compared to the predicate device indentified in K023117. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an abstract human form or a caduceus, rendered in black. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. David Nowicki President Exact Medical Manufacturing, Incorporated 4917 William Street. Suite C Lancaster, New York 14186 2010 SEE 3 Re: K101593 Trade/Device Name: Exact Medical Manufacturing Surgical Gowns SMS w/PE Layer Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: June 4, 2010 Received: June 8, 2010 Dear Mr. Nowicki: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing 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. {2}------------------------------------------------ #### Page 2- Mr. Nowicki 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance, 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Anthony D. West Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ SEP 3 2010 K101593 Page 26 # Indications for Use Form Indications for Use: 510(k) Number (if known): Device Name: Exact Medical Manufacturing Surgical Gown SMS w/PE Layer Indications for Use: Exact Medical Manufacturing Surgical Gown SMS w/PE Layer are sterile or nonsterile single use devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The Exact Medical Manufacturing Surgical Gown SMS w/PE Layer are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) الماركة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة الم (Division Sign-Off) (Division Sign-On) Division of Anesthesiology, General Hospital Provinsion of Anesthesional Payines Division Control, Dental Devices 510(k) Number. K101593