MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles facing to the right, with flowing lines beneath them. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR - 2 2000 Ms. Lara N. Simmons Corporate Director, Regulatory Affairs Medline Industries, Inc. One Medline Place 60060-4486 Mundelein, Illinois Re : K993170 Medline Breathable, Impervious Disposable Trade Name: Surgical Gowns Regulatory Class: II FYA Product Code: Dated: January 25, 2000 February 1, 2000 Received: Dear Ms. Simmons: 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, Drug, 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 requlations affecting your device can be found in the Code of Federal Regulations, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of {1}------------------------------------------------ Page 2 —Ms. Simmons the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance 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 obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/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 {2}------------------------------------------------ Medline Industries, Inc. Image /page/2/Picture/1 description: The image shows the Medline logo. The logo features the word "MEDLINE" in a bold, sans-serif font. Above the word is a stylized compass rose design, with four points extending outwards. The compass rose is black, matching the text. One Medime Place Mundelein. Illinois 60060.4486 1-847-949-2639 WATS: 1-800-950-0128 Fax: 1-847-949-2643 Lara N. Simmon Director of Regulatory Afiants Intended Use Image /page/2/Picture/6 description: The image shows the text "SK-5" in the upper left corner. There is also the text "23 FEB 03 10" vertically oriented in the middle right of the image. The text "FD4/GDH/OD/DHC" is also vertically oriented to the right of the date. The word "Page" is visible, along with the number 77. 510(k) Number (if known): ___K993170 Device Name: Medline Breathable, Impervious Disposable Surgical Gowns Indications for Use: Medline Breathable, Impervious Surgical Gowns are single-use gowns intended to be worn by operating room personnel during surgical procedures to help protect both the patient and the health care worker from transfer of micro-organisms, body fluids and particulate material. (PLEASE DO NOT WRITE BLOEW 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 X Clus S. lin (Optional Format 12-96) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number Y993170