TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a logo with a stylized bird in flight. The bird is composed of three parallel lines that curve to form the body, wings, and tail. The logo is encircled by text, which is difficult to read due to the image quality. The overall design is simple and abstract, suggesting movement and freedom. Pood and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO56-G609 Silver Spring, MD 20993-0002 Kunshan Jiehong Non Woven Product Company, Limited C/O Mr. Glen Feye President Accurate Consultants Incorporated i 340 West Pennsylvania Avenue San Diego, California 92103 SEP 2 9 2011 Re: K112136 Trade/Device Name: Surgical and Equipment Drape-Sterile and Non Sterile Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: July 20, 2011 Received: July 26, 2011 Dear Mr.Feve: 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. {1}------------------------------------------------ Page 2 - Mr. Feye Enclosure 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 hmited 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.html for the CDRH²'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.hum. Sincerely yours, Th for 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 {2}------------------------------------------------ ## Indications for Use Statements Section 5: ## Indications for Use 510(k) Number (if known): K | | 2136 Device Name: Surgical and Equipment Drape-Sterile and Non Sterile Indications for Use: Disposable sterile drapes are intended for use for : - patient protective covering used to isolate incision sites and protect . against contamination during surgical procedures. - cover a variety of surgical and non-surgical equipment in various settings . throughout the clinical setting. These drapes are used protect surgical and non-surgical equipment from contamination during surgical procedures Drapes provided as sterile and non-sterile surgical drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Drapes are to be sold directly to users after EtO sterilization validation to ISO 1135. The following disposable surgical drape types and model numbers are included in this submission | MATERIAL | DRAPE STYLE | STERILE | DRAPE TYPE | MODEL # | |----------|-------------------|-------------|------------|-----------------| | SMS | Non<br>Reinforced | Sterile | Top | JHSAD 150-240E | | | | | Bottom | JHSAD 180-175E | | | | Non Sterile | Top | JHSAD 150-240NS | | | | | Bottom | JHSAD 180-175NS | Prescription Use (Part 21 CFR 801 Subpart D) AND/OR : Over-The-Counter Use X (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Kunshan Jiehong NonWoven Product Corp. Ltd. Section 510(k) Notification Surgical and Equipment Drapes Eliford F. Clario - Wille (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: