PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS

{0}------------------------------------------------ 2. # K971547 #### 111 1 9 1007 510(k) SUMMARY ರ. #### SUMMARY OF SAFETY AND EFFECTIVENESS A. - Playtex Products Inc. . COMPANY NAME l. 215 College Road . ADDRESS - P. O. Box 728 Paramus, New Jersey 07652 - 201-265-8000 -TELEPHONE - M. Rosengarten CONTACT PERSON . Director of Regulatory Affairs - June 17, 1997 DATE OF SUMMARY - - Playtex Tampons DEVICE NAME ﻪ #### Scented Deodorant and Unscented CLASSIFICATION NAME -Menstrual Tampons - The new Playtex tampons are substantially equivalent to previously 3. cleared Playtex Gentle Glide®, Slimfits™ and Soft Comfort™ Tampons, Regular, Super and Super Plus. - The device description is: Scented or scented deodorant and unscented 4. menstrual tampons for the absorption of menstrual fluid. - Playtex tampons are intended to be used as scented, scented deodorant and న. unscented menstrual tampons for the absorption of menstrual fluid. - ર્ભ. The new tampon has the same technological characteristics as the predicate device and has the same mode of action. - 1. Nonclinical testing referenced for the determination of substantial equivalence B. includes: Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion and TSST-1 toxin testing. - Based on the review of the data referenced in this "510(k) Summary," the 2. Playtex Tampons are substantially equivalent to the predicate device in terms of safety and effectiveness. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### JUN 1 9 1997 21 CFR §884.5460/Product code: 85 HIL 21 CFR §884.5470/Product code: 85 HEB Playtex Tampons #11-197 ... . Dated: April 21, 1997 Regulatory class: II Received: April 28, 1997 Re: K971547 Mr. Mark E. Rosengarten Director, Regulatory Affairs ... Research & Development Playtex Products, Inc. 215 College Road, P.O. Box 728 Paramus, New Jersey 07652 ંદ્ર 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 Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 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 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 diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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, Lillian Yin, Ph.D. Director, Division of Reproduc Abdominal, Ear, Nose and Throat/ 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): _ K 9 7 15 47 Device Name: __ Playtex Tampon _______________________________________________________________________________________________________________________________________________ Indications For Use: Scented or scented deodorized tampons for absorption of menstrual fluid. 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) | | <i>Robert P. Ratliff</i> | |--|--------------------------| | | (Division Sign-Off) | Division of Reproductive, Abdominal, ENT, and Radiological Devices | 510(k) Number | K971547 | |---------------|---------| |---------------|---------| Prescription Use_ (Per 21 CFR 801.109) OR Over-The-Counter Use_{ (Optional Format 1-2-96)