JOYKEY SURGICAL GOWNS (STERILE)

{0}------------------------------------------------ ## 510(K) SUMMARY K062479 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92 MAR 1 4 2007 - JOYKEY INDUSTRYIAL LTD. 1 . Submitter's Name: Unit 7-8,23rd Floor, No. 1, Hung To Road, Kwun Tong, Address: KL . Hong Kong 852-2612-0951 Phone: Fax: 852-2615-9138 Ms. Ting-Yu Chang (President) Contact: - 2. Device Name Trade Name: JOYKEY Surgical Gowns(Sterile) Common Name: Sterile Surgical Gowns GOWN , SURGICAL Classification name: - Classification: Class II 3. - Predicate Device: 4. - Device Description: 5. JOYKEY Surgical Gowns (Sterile) are non-reinforced surgical Gowns manufactured from non-woven fabric. The surgical Gown is supplied sterile and for single use only. Master & Frank Surgical Gowns (Sterile) (K012186) marketed by Master & Frank Enterprise Co., Ltd. - Intended Use: ్. JOYKEY Surgical Gowns (Sterile) are single use article of surgical apparel 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. Section 4 - 510(k) Summary {1}------------------------------------------------ 7. "Performance Summary: In terms of Physical specification, The dev to ASTM F1670-03 Barrier properties against blood and body fluids & ASTM D1424 , ASTM D5034 & NFPA Flammability standards --- etc. The device also conforms to Biological standards of ISO 10993 series, Gamma Sterilization standard of ISO 11137. ## Conclusions: 8. The JOYKEY Surgical Gowns (Sterile) have identical intended use and technological characteristics as the Master & Frank Surgical Gowns (Sterile) (K012186). Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the JOYKEY Surgical Gowns (Sterile) are substantially equivalent to the predicate devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human profiles facing to the right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that creates a sense of depth and unity. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 4 2007 Joykey Industryial, Limited C/O Ms. Jennifer Reich 2904 North Boldt Drive Flagstaff, Arizona 86001 Re: K062479 Trade/Device Name: JOYKEY Surgical Gowns (Sterile) Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: February 15, 2007 Received: February 20, 2007 Dear Ms. Reich: 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 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. {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. Page 2 -Ms. Reich Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 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 (240) 276-0115. 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/industry/support/index.html. Sincerely vours. CaeG Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): _K 06 2479 Device Name: JOYKEY Surgical Gowns (Sterile) JOYKEY INDUSTRYIAL LTD. Indications For Use: JOYKEY Surgical Gowns (Sterile) are single use article of surgical apparel 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. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Shula A. Murphy, MD Page 1 of 1 V