DISPOSABLE SURGICAL GOWNS

{0}------------------------------------------------ OCT 16 2012 ## Exhibit #2 510(k) Summary This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) Number: K120192 Date of Submission: September 25, 2012 1. . मं Sponsor > Weihai Hongyu Nonwoven Fabric Products Co., Ltd. 9-1 Pudong Road, Area of Economy and Technique, Weihai. China, 264205 Establishment Registration Number: 3008489813 Contact Person: Yanfei Liu Position: Registration Manager Tel: + (86)-631-3636943 Fax: + (86)-631-3636910 Email: liuyanfei340@163.com 3. Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net 4. Proposed Device Identification Proposed Device Name: Disposable Surgical Gowns Proposed Device Model: M, L, XL, XXL Classification: II Product Code: FYA Regulation Number: 21 CFR 878.4040 Review Panel: General& Plastic Surgery {1}------------------------------------------------ Intended Use Statement: Disposable Surgical Gowns, which are blue colored and EO sterilized, are indicated 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. It could achieve Level 3 Barrier Performance as per AAMI PB70:2003. It is for single use only. - Predicate Device Identification 5. Predicate device for Disposable Surgical Gowns 510(k) Number: K100971 Product Name: Hangzhou ATek Medical and Textile Surgical Gowns Manufacturer: Hangzhou ATek Medical and Textile Co. Ltd. #### 6. Device Description Disposable Surgical Gowns 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. Disposable Surgical Gowns are manufactured from three layers nonwoven fabric that is comprised of Spunbond (SMS) materials. Disposable Surgical Gowns are reinforced with an additional layer of SPP (Syndiotactic Polyprogylene) laminating film in the sleeve and body areas for higher barrier protection. The proposed Disposable Surgical Gowns include four sizes, which are presented in Table V-1 General Description | Table v-1 General Description of Proposed Device | | | | | | |--------------------------------------------------|----------|------|-------|------------|---------------| | Proposed Device | Material | Size | Color | Style | Sterility | | Disposable<br>Surgical Gowns | SMS | M | Blue | Reinforced | EO Sterilized | | | | L | Blue | Reinforced | EO Sterilized | | | | XL | Blue | Reinforced | EO Sterilized | | | | XXL | Blue | Reinforced | EO Sterilized | 1 Description of Proposed Device #### Non-Clinical Test Conclusion 7. Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: {2}------------------------------------------------ - ASTM F2407-06 Standard Specification for Surgical Gowns Intended for Use in Healthcare > Facilities - AAMI PB70-2003 Liquid barrier performance and classification of protective apparel and drapes ﺮ intended for use in health care facilities - AATCC 42-2000 Water Resistance: Impact Penetration Test; > - AATCC 127-2003 Water Resistance: Hydrostatic Pressure Test; V - 16 CFR Part 1610:2008 Standard for the Flammability of Clothing Textiles ア - ASTM D 5034 09 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics ﺮ (Grab Test) - ASTM D 5733 99 Standard Test Method for Tearing Strength of Nonwoven Fabrics by the ア Trapezoid Procedure - v. A STM D 1683 - 07 Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics - ISO 9073-10:2003 Textiles Test Methods for Nonwovens Part 10: Lint and Other Particles ﺮ Generation in the Dry State - ASTM F 1868 02 Standard Test Method for Thermal and Evaporative Resistance of Clothing ア Materials Using a Sweating Hot Plate - Part B - Isothermal Evaporative Resistance - ISO 10993-5:2009: Biological Evaluation of Medical Devices Part 5: Tests for in vitro ﺮ Cytotoxicity - ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin ア sensitization - ISO 11135-1:2007 Sterilization of health care products- Ethylene oxide- Part 1: Requirements for ﺮ development, validation and routing control of a sterilization process for medical devices | Item | Proposed Device | Predicate Device | | | | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------| | Product Code | FYA | FYA | | | | | Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | | | | | Class | II | II | | | | | Intended Use | Disposable Surgical Gowns are intended to<br>be worn by operating room personnel during<br>surgical procedures to protect both the<br>surgical patient and the operating room<br>personnel from transfer of microorganisms,<br>body fluids, and particulate material. | Disposable gowns are worn by operating room<br>personnel during surgical procedures to protect<br>both the surgical patient and OR personnel<br>from the transfer of body fluids and particulate<br>material. | | | | | Style | Reinforced | Reinforced and Non-reinforced | | | | | Size | M, L, XL, XXL | L, XL, XXL | | | | | Color | Blue | Unknown | | | | | Weight per square | 45 g/m² | Unknown | | | | | | Thickness | 0.16mm | Unknown | | | | Physical Specifications | Resistance to Blood and Liquid Penetration | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 | | | | | Resistance to Tear | ≥20 N | ≥20 N | | | | | Fire Protection | Class I | Class I | | | | | Features for Safe Use | Free of toxic ingredients<br>the average value of coefficient of variation<br>of linting is 6.2%<br>Free of Nonfast dyes | Free of toxic ingredients<br>Unknown<br>Free of Nonfast dyes | | | | | Mechanical specifications | Burst strength | ≥40 Kpa | ≥40 Kpa | | | Tensile strength | | ≥20 N | ≥20 N | | | | Durability | | Disposable | Disposable | | | | | Performance Testing | Conform to<br>AATCC 42-2000<br>AATCC 127-2003<br>16 CFR Part 1610:2008<br>ASTM D5034 - 09<br>ASTM D5733 - 99<br>ASTM D1683 - 07<br>ISO 9073 Part 10:2003<br>ASTM F1868 - 02 | Conform to<br>AATCC 42-2000<br>AATCC 127-2003<br>16 CFR Part 1610:2008<br>ASTM D5034 - 09<br>ASTM D5733 - 99<br>ASTM D1683 - 07<br>ISO 9073 Part 10:2003<br>ASTM F1868 - 02 | | | | | | | Material | SMS, SPP, Polypropylene, PE, Nylon, Polyester | SMS, Hydro-Entangled (Spunlace), SFT | | | | | Biocompatibility | Conform to the requirement of ISO 10993 series Standards | Conform to the requirement of ISO 10993 series Standards | | | | | | | Cytotoxicity | | | | | Irritation | No intracutaneous reactivity | No intracutaneous reactivity | | | | | Sensitization | No delayed dermal contact sensitization | No delayed dermal contact sensitization | | | | Sterilization | SAL | 106 | 106 | | Method | EO Sterilization | | EO Sterilization | | | | Validation | Conforms to ISO 11135 | | Conforms to ISO 11135 | | | | Package Integrity | Conforms to ISO 11607 | | Conforms to ISO 11607 | | | | EO Residual | Conforms to ISO 10993-7 | | Conforms to ISO 10993-7 | | | | | Label and Labeling | Conforms to FDA Requirements | Conforms to FDA Requirements | | | #### 8. Summary of Comparison E2-3 {3}------------------------------------------------ Exhibit #2 510(k) Summary · . · . . , · . · : . : E2-4 . --- : {4}------------------------------------------------ 1:2-5 ### 9. Substantially Equivalent Conclusion · ・ The proposed devices, Disposable Surgical Gowns, are determined to be Substantially Equivalent (SE) to the predicate device, Hangzhou ATek Medical and Textile Surgical Gowns (K100971), in respect of safety and effectiveness. 1 ・ י י : {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 OCT 1 6 2012 Weihai Hongyu Nonwoven Fabric Products Company, Limited C/O Ms. Diana Hong General Manager Mid-Link Consulting Company, Limited P.O. Box 237-023 Shanghai, 200237 China Re: K120192 Trade/Device Name: Disposable Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: September 25, 2012 Received: October 1, 2012 · Dear Ms. Hong: 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. {6}------------------------------------------------ ### Page 2- Ms. Hong 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. Antion V. Van 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 {7}------------------------------------------------ # Indications for Use 510(k) Number: Device Name: Disposable Surgical Gowns Proposed device model: M, L, XL and XXL Indications for Use: Disposable Surgical Gowns, which are blue colored and EO sterilized, are indicated 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. It could achieve Level 3 Barrier Performance as per AAMI PB70:2003. It is for single use only. ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D) ### OVER-THE-COUNTER USE (21 CFR 801 Subpart C) # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Elizabeth F. Clamie. William (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices K120192 510(k) Number: