MED-GUARD SURGEON'S GOWN

{0}------------------------------------------------ K992445 ## 510(k) Summary - Kappler USA, Inc. a (1) PO Box 218 Guntersville, AL 35976 Contact: Philip Mann (256) 205-4146 Prepared: August 18, 1999 - a (2) Device Name: Surgical Gown Proprietary Name: Med-Guard Surgical Gown Classification Name: Gown, Surgical - This surgical gown is similar in design and composition to the Kimberly Clark gown identified in a (3) pre-market notification #K781682. - The Kappler Med-Guard surgical gown is constructed from a tri-layer composite material which is a (4) 100% polypropylene. The specific arrangement is spunbonded polypropylene/meltblown polypropylene film/spunbonded polypropylene. The fabric is treated with an anti-static agent. - The surgical gown is intended to protect the wearer from blood and other body fluids encountered a (5) during surgery. - a (6) The following table provides a comparison of the technological characteristics of the Kappler Med-Guard surgical gown and the Kimberly-Clark surgical gown. Description of the test methods are provided in section b.1. The K-C results were obtained from their own published literature. | CHARACTERISTIC | MED-GUARD | K-C | |----------------------------------|--------------------|--------------------| | Material Composition | 100% Polypropylene | 100% Polypropylene | | Configuration | Tri-laminate | Tri-Laminate | | Barrier Layer | Meltblown | Meltblown | | Composite Weight | 1.8 oz./yd2 | 1.5 oz./yd2 | | Hydrostatic Head | 44.0 cm | 20.7 inches | | Bacterial Filtration | 78% | 81.3% | | Moisture Vapor Transmission Rate | 1789 g/24 hm2 | 1794 grs/sqm/24 hr | | Flammability | Class 1 | Class 1' | | Sterilization | 100% ETO | 100% ETO | | Anti-static treatment | Yes | Yes | {1}------------------------------------------------ - The non-clinical testing was performed to describe the physical, barrier and comfort b (1) characteristics of the gown fabric. The individual test data sheets identify the samples as "Blue Hawk", which was a research and development name for the fabric in the Med-Guard gown. Hydrostatic Pressure Resistance (ASTM D 751 Procedure B) - Provides a measure of the gown material resistance to a column of water. The results are expressed in the highest column resisted before failure occurs. See Enclosure A. Bacterial Filtration Efficiency (SOP/ARO/007F.1/MIL-M-36954C) - Provides a measure of material resistance to bacteria laden aerosol with a mean particle size of approximately 3.0 microns. Results are expressed as a percentage of filtration. The test was performed on sterile material. See Enclosure B. Moisture Vapor Transmission Rate (ASTM E 96 Method B) - Provides a measure of the gown material to pass water vapor and results are expressed in weight per unit area per unit time. Indicates a level of comfort for the wearer through ability to allow body perspiration to escape. See Enclosure C. Standard Classification for Flammability (NFPA 702) - Provides a measure of the rate of burning of the gown material when ignited. Med-Guard shows the Class I flammability, which is defined as "relatively slow burning". See Enclosure D. Ball Bursting Strength (ASTM D 751, Sec. 18.2) - Provides a measure of the physical strength of the gown material. Testing was performed on both sterile and non-sterile material to ensure sterilization would not adversely impact seam strength. See Enclosure E. Breaking Strength (ASTM D 751, Sec. 11, Procedure A-Grab) - Provides a measure of the physical strength of the gown material. Testing was performed on both sterile and non-sterile material to ensure sterilization would not adversely impact physical strength. See Enclosure E. Tear Strength (ASTM D 5733, Trapezoid Procedure) - Provides a measure of the physical strength of the gown material. See Enclosure E. Colorfastness Evaluation of Non-wovens - Study consisted of performing water and saline extracts on the product after exposure to a normal steam cycle. See Enclosure E. The product is 100% ETO sterilized. See Enclosure F. - b (2) The clinical testing was performed to ensure the addition of the anti-static treatments presented no concerns of safety and effectiveness. The clinical protocol was established by North American Science Associates, Inc. (NAmSA). The protocol provided for the following testing: Acute Systemic Toxicity - Hemolysis Test provides data to support no evidence of toxic effects from exposure to the treatment. See Enclosure G. Cytotoxicity - MEM Emultion is a measure of the cytotoxicity of extractable substances exposed to cellular monolayers. See Enclosure H. Delayed Contact Sensitization Study - Provides data to show no evidence of irritation from exposure to the treatment. See Enclosure I. Based on the results of the testing, NAmSA concluded that no concerns of safety or effectiveness resulted from the addition of the anti-static treatment. {2}------------------------------------------------ - The results of the non-clinical and clinical tests show the Kappler Med-Guard gown to be safe and b (3) effective. The results also show the gown to be equivalent to the predicate device. - . {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 8 2000 Mr. Philip C. Mann Technical and Customer Support Manager Kappler Protective Apparel & Fabrics P.O. Box 218 35976 Guntersville, Alabama Re : K992445 Trade Name: Med-Guard Surgical Gown Requlatory Class: II Product Code: FYA Dated: January 24, 2000 January 28, 2000 Received: Dear Mr. Mann: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in {4}------------------------------------------------ Page 2 - Mr. Mann the Federal Register. Please note: this response to your ene reactar notification submission does not affect any premarket notificacion baxilder sections 531 through 542 of obligation you might have the Electronic Product Radiation Che Act for devices ander one ederal laws or regulations. This letter will allow you to begin marketing your device as first recei will as on the premarket notification. The FDA described in your sia ... puivalence of your device to a legally rinding of substancial equired in a classification for your markeed predicals and the your device to proceed to the market. If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in reguladiagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compriance at (501) 333 tising of your device, please contact che promocion and liver at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Informacion on Jourision of Small Manufacturers Assistance obeathed from eno number (800) 638-2041 or (301) 443-6597 or at at its corr rrec namber (6:1/www.fdaygov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Page **_ of _** | Labels | Values | |---------------------------|--------------------------| | 510(k) Number (if known): | K992445 | | Device Name: | MED-GUARD, Surgical Gown | Indications For Use: The gown is intended to protect the pa wearer from blood and other body fivids encountered during surgery (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use √ (Optional Format 1-2-96) (Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 510(k) Number _