BARRIER SURGICAL GOWNS

{0}------------------------------------------------ **510(k) SUMMARY** K030786 | Applicant: | Mölnlycke Health Care<br>826 Newtown Yardley Rd.<br>Newtown, PA 18940 | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | John Clay<br>Regulatory Affairs Officer | | Tel.: | 267-685-2078 | | Fax: | 267-685-2010 | | Device Name: | | | Proprietary Name: | Barrier® Surgical Gowns | | Common/Usual Name: | Surgical Gowns | | Device Classification: | Class II - 21 CFR 878.4040 | | Substantial Equivalence: | For the purpose of Section 510(k) of the Federal Food, Drug and<br>Cosmetic Act, Mölnlycke Health Care considers the BARRIER®<br>Surgical Gowns are substantially equivalent in composition,<br>function and intended use to the previously marketed BARRIER®<br>Surgical Gowns. | | Intended Use: | BARRIER® surgical gowns are intended for single use to be worn<br>by the Surgical Team Members in the operating room during<br>surgical procedures to protect both the patient and the operating<br>room personnel from the transfer of microorganisms, body fluids<br>and particulate material. | | Description: | The BARRIER® Surgical Gowns have been designed with an<br>assortment of fabrics and have been on the market for a number of<br>years cleared under predicate 510(k) notifications. BARRIER<br>surgical gowns have been developed for general surgical<br>procedures and for procedures which represent possible exposure<br>to bloodborne pathogens and other potentially infectious materials<br>which require increased levels of protection. | {1}------------------------------------------------ #### BARRIER 510(k) Summary, Page 2 The following chart highlights the current BARRIER surgical gown families and the predicate 510(k) notifications under which they are currently marketed. | Description | Predicate 510(k) | |-----------------------------------------------------------------------------------|------------------| | BARRIER® Standard and Standard<br>Fabric Reinforced Surgical Gowns | K760903 | | BARRIER® Extra and Ultra Protection<br>Gowns | K760903 | | BARRIER® Extra and Ultra Protection<br>Plus Surgical Gowns | K932731 | | BARRIER® Surgical Gown II and<br>BARRIER® Surgical Gown II , Fabric<br>Reinforced | K920996 | | BARRIER® Fluid Protection Plus<br>Surgical Gowns | K990395 | | BARRIER® Urology Gown | K760903 | # Summary of Testing: BARRIER® Surgical Gowns have been evaluated using the ANSI/AAMI PB-70:2003 Standard. (Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities) The chart represents the AAMI levels claimed for each gown family. | Description | Level of Protection according to AAMI | |-----------------------------------------------------------------------------------|---------------------------------------| | BARRIER® Standard and Standard<br>Fabric Reinforced Surgical Gowns | Level 2 | | BARRIER® Extra and Ultra Protection<br>Gowns | Level 3 | | BARRIER® Extra and Ultra Protection<br>Plus Surgical Gowns | Level 4 | | BARRIER® Surgical Gown II and<br>BARRIER® Surgical Gown II , Fabric<br>Reinforced | Level 3 | | BARRIER® Fluid Protection Plus<br>Surgical Gowns | Level 3 | | BARRIER® Urology Gown | Level 4 | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. 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 - 9 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. John Clay Regulatory Affairs & Quality Officer-US Mölnlycke Health Care 826 Newtown-Yardley Road, Suite 300 Newtown, Pennsylvania 18940 Re: K050786 Trade/Device Name: BARRIER® Surgical Gowns Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: April 19, 2005 Received: April 22, 2005 Dear Mr. Clay: We have reviewed your Section 510(k) premarket notification of intent to market the device we have ro rowed your and have determined the device is substantially equivalent (for the relerenced above and nave attermclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Ameliuments, or to act roos that nortic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents or 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 If your device to such additional controls. Existing major regulations affecting (I MA), it may be subject to back of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the reannouncements concerning your device in the Federal Register. {3}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not I least to advisod that 1 Da determination that your device complies with other requirements Incall that I D'I may Federal statutes and regulations administered by other Federal agencies. of the Act of any I oderal statuse and submitted to: but not limited to: registration 1 ou must comply with and 1); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF RP art 867), laceling (QS) regulation (21 CFR Part 820); and if requirements as bet ferm nroduct 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) This letter will anow yourse bogan made of substantial equivalence of your device to a premarket notified.com - The PDF 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), If you desire specific at not 100 your 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 may obtain other generational and Consumer Assistance at its toll-free Divisor (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Clair 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 {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K050786 Device Name: BARRIER® Surgical Gowns Indications for Use: BARRIER® surgical gowns are intended for single use to be worn by the Surgical Team Members in the operating room during surgical procedures to protect both the patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use X (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) Shula H. Murphy, MD of Anesthesiology, General Hospital, n Control, Dental Devices Number: K050 786 Page __ of