COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a black and white emblem. The emblem is in the shape of a shield. Inside the shield is a large letter 'S' with a smaller letter 'C' above it. ## STANDARD T MAY - 5 2005 K041540 ## COMBOsafe™ SURGICAL GOWNS SAFETY AND EFFFECTIVNESS SUMMARY The following information is being supplied in accordance with the Safe Medical Device Act of 1990. 807.92(a) - 1. Standard Textile Co., Inc. One Knollcrest Drive Cincinnati, Ohio 45237 Contact Person: Brad Bushman (513) 761-9255 Ext. 455 - 2. Device Name: COMBOsafe™ Surgical Gowns (Europe) ProMax Surgical Gowns (US) Common/Usual Name: Non-Sterile Surgical Gown, Operating Room Gown, Isolation Gown Classification Name: Surgical Apparel 21 C.F.R. § 878.4040 - ന് All fabric components used in COMBOsafe™ Surgical Gowns are made from 100% polyester. dyed blue and/or green and are laminated with a urethane film. COMBOsafe Surgical Gowns will function as surgical gowns when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies. - ব COMBOsafe Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown. Per ANSI/AAMI PB70:2003, COMBOsafe surgical gowns with the patented "inverted" 2-ply sleeve designs are classified as a Level 4 Barrier. - The tests that have been successfully completed include: ട്. - Flammability 16 CFR Part 1610. a. - Barrier Performance b. - Suter Hydrostatic Testing AATCC #127-1989 1. - Mullens Hydrostatic Testing ASTM D751-95 Procedure A ii. - Viral Resistance Testing ASTM 1671-97 iii. - Strength ASTM #D-1682-87 C. - Lint EDANA 220.0-96 ರ. - Toxicity Cytotoxicity MEM Elution (MG023) e. Acute Systemic Toxicity (ISO 10993) - f. Primary Skin Irritation (ISO 10993) - Sterilization Product sold non-sterile; can be sterilized using prevacuum steam cycles. ். - h. Durability through 75 processing (wash, dry and sterilization). - Colorfastness to Commercial Laundering AATCC #61-1993(4A). i. To the best of my knowledge, all data and information in the 510(k) are truthful and accurate, and that no material fact has been omitted. Bradley J. Bush 6/4/04 Bradley J. Bushman ONE KNOLLCHEST D 80 x 37 x 37 1805 CINCINNATI OHIO 15222-1805 513 761 9255 513 761-0467 ^/ 1 800 939 0400 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. MAY - 5 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Bradley J. Bushman Vice President, Technical Affairs Standard Textile Company Limited One Knollcrest Drive Cincinnati, Ohio 45237 Re: K041540 Trade/Device Name: COMBOsafe/Promax Surgical Gowns Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: April 28, 2005 Received: April 29, 2005 Dear Mr. Bushman: 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 referenced as over and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendie conmise of prives 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 (1 writ), it may of backed of Federal Regulations, Title 21, Parts 800 to 898. In your device ear. 80 foundsh further announcements concerning your device in the Federal Register. {2}------------------------------------------------ Page 2 – Mr. Bushman 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. or the For or any 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 und libing (21 es 1 forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as lectronic 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) Print reter mification. The FDA finding of substantial equivalence of your device to a promation in the can be 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), 11 Jou decire 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 maj South 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 yours, Chiu Lin, Ph.D. 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 {3}------------------------------------------------ ## Indications for Use #K041540 510(k) Number (if known): COMBOsafe/Promax Surgical Gowns Device Name: Indications For Use: COMBOsafe/Promax Surgical Gowns are medical devices that are intended to be worn by the migral and the false in the provised procedures to protect them by inhibiting the migr COMBOsafe/Promax Surgical Gowns are medical devices to protect them by inhibiting the migration operating room personal processfores of the gotties areas of the gown. operating room personnel during surgicul province of the gown. of liquids through the surface of the critical areas of the gown. of agence in the promote will function as surgical gowns will function when processed according will be COMBOsafe/Promax Surgical Gowns will thirdinal surgical govine These products will be to instructions the the belows wash, dry and sterlized on be sterlized and to instructions through 75 complete wash, dry and sternization cover. manufactured and distributed as non-steries surgical governments are and Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use ﻜﺮ (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) Shule H. Mungber, 5/15/05 Sion-City Insion of Anesthesiolooy, General Hospital, Intection Control, Dental Devices (K) Number: K 41540 Page 1 of _1 Starter Frances