KIMBERLY-CLARK PROCEDURE GOWN

{0}------------------------------------------------ K052824 ### Premarket Notification [510(k)] Summary | 1. | Submitted by: | Kimberly-Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076 | | |----|-------------------------------------|-----------------------------------------------------------------------------|--| | | Contact Person: | Cheryl M. Sanzare<br>Associate Director Regulatory Affairs | | | | Telephone:<br>Facsimile:<br>e-mail: | (770) 587-7131<br>(920) 380-6308<br>cheryl.sanzare@kcc.com | | April 26, 2006 Date Prepared: ### 2. Device Name Trade / Proprietary Name: Kimberly-Clark Procedure Gown Common / Usual name: Surqical gown Gown, surgical (per 21CFR 878.4040) Classification Name: ### 3. Predicate Device Kimberly-Clark Procedure Gown is substantially equivalent to the The Kimberly-Clark Impervious Open Back Gown cleared under K880382. #### 4. Intended Use of the Device The Kimberly-Clark Procedure Gown is a non-sterile, disposable, single use item of apparel intended to be worn by healthcare professionals during the preparation and administration of selected chemotherapy drugs. The gown is not intended to be worn during surgical procedures. #### 5. Description of the Device The Kimberly-Clark Comfort Gown is an open back gown manufactured from a non-woven fabric with a film laminate coating. The non-woven fabric is a polypropylene spunbond with a polyethylene coating. The composition of the gown fabric resists tearing and permeation by various chemotherapy drugs for up to four hours of use. {1}------------------------------------------------ # Premarket Notification [510(k)] Summary (Continued) ### Summary of the technological characteristics of the device compared to 6. the predicate device The Kimberly-Clark Procedure Gown and the Kimberly-Clark Impervious Open Back Gown (K880382) are manufactured with similar materials of construction. Neither gown is intended to be worn during surgical procedures as both gowns are provided as non-sterile. The K-C Procedure Gown is substantially equivalent to the K-C Imperious Open Back Gown in that they both provide the following characteristics: good tear resistance and fluid barrier. | Summary of Testing: | | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Test | Result | | Dermal Irritation & Sensitization | No evidence of dermal irritation<br>or allergic contact sensitization | | Flammability | Meets Class I flammability<br>requirements per NFPA Standard<br>#702-1980. | | Liquid Chemical Permeation | Permeation testing per ASTM F 739-<br>99a with the following chemotherapy<br>drugs: carmustine, cisplatin,<br>cyclophosphamide, dacarbazine,<br>doxorubicin hydrochloride,<br>etoposide, fluorouracil, paclitaxel,<br>thioTEPA and vincristine sulfate.<br>Results showed no permeation of<br>the drugs for up to 240 minutes. | | Fluid Penetration | Penetration testing per ASTM-F<br>1670-03 with resistance of the gown<br>fabric to penetration by blood under<br>conditions of continuous liquid<br>contact. The 'pass' determination<br>was based on visual detection of<br>synthetic blood penetration. | | Viral Penetration | Penetration testing per ASTM-F 1671-<br>03 with resistance of the gown fabric to<br>penetration by blood-borne pathogens<br>under conditions of continuous liquid<br>contact. The 'pass' determination was<br>based on detection of viral penetration. | Section of the courses {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 eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 2006 Ms. Cheryl M. Sanzare Associate Director Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076 Re: K052824 Trade/Device Name: Kimberly-Clark Procedure Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: April 10, 2006 Received: April 11, 2006 Dear Ms. Sanzare: 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}------------------------------------------------ Page 2 - Ms. Sanzare 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 yours. Chiu-Ling, 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 | Applicant: | Kimberly-Clark Corporation | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number: | K052824 | | Device Name: | Kimberly-Clark Procedure Gown | | Indications for Use: | Based upon 21CFR§878.4040; Surgical apparel | | | The Kimberly-Clark Procedure Gown is a non-sterile,<br>disposable, single use item of apparel intended to be<br>worn by healthcare professionals during the<br>preparation and administration of selected<br>chemotherapy drugs. The gown is not intended to be<br>worn during surgical procedures. | ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ONANOTHER PAGE IF NEEDED) ## Concurrence of CDRH Office of Device Evaluation (ODE) | Prescription Use | |------------------| |------------------| Over-the-Counter ズ Shuli Hughes 5/1/66 Or Ance II.aelology, General Hospill : Control. Dental Devices K 052824 Station and the control of the country