PLAYTEX TAMPONS #03498

{0}------------------------------------------------ K 980478 ## SUMMARY OF SAFETY AND EFFECTIVENESS 9. 1171 - Dioxin Analysis ♪ - Primary Dermal Irritation in Rabbits Non-Irritating ♪ - APR 3 1998 - ♪ Acute Oral Toxicity in Rats - Non-Toxic - Subacute Vaginal Irritation in Rabbits Non-Irritating ♪ - Agar Diffusion Study No zones of inhibition were detected ♪ - TSST-1, Toxin testing was previously conducted on the same rayon pledget ♪ submitted in K971174; results are in the range of values of commercially sold tampons. - 200 person Human Repeat Insult Patch Test. ♪ {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 - 3 1999 Mr. Mark E. Rosengarten Director, Regulatory Affairs 215 College Road P.O. Box 728 Paramus, NJ 07652 Re: K980478 Playtex Tampons #03498 (Unscented) Dated: February 3, 1998 Received: February 6, 1998 Regulatory Class: II 21 CFR 887.5470/Procode: 85 HEB Dear Mr. Rosengarten: 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 Comments Act (Act). You may, therefore, narket 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Feleval Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Proctice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 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 predication 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 diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/dsmaldsmam.html". Sincerely yours Lillian Yin, Ph.D. Director, Division of Reproducti Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## STATEMENT OF INDICATIONS OF USE PAGE Page _1_ of _1_ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _ Playtex Gentle Glide®, Soft Comfort™ and Slimits ™ Tampons Indications For Use: Unscented menstrual tampons for absorption of menstrual fluid. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Robert Matting (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K980478 Prescription Use. (Per 21 CFR 801.109) ﻤﻌﺘﻤ OR Over-The-Counter Use_ (Optional Format 1-2-96) ﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﺍﯾﺮﺍﻥ ﺍﯾﺮﺍﻥ ﺍﯾﺮﺍﻥ ﺍﯾﺮﺍﻥ ﺍﯾﺮﺍﻥ ﺍﯾﺮﺍﻥ ﺍﯾ