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510(k) K812534

IMPROVED PLAYTEX TAMPON by Playtex, Inc. — Product Code HIL

K812534 is an FDA 510(k) premarket notification submitted by Playtex, Inc. for the device "IMPROVED PLAYTEX TAMPON". The FDA issued a decision of Substantially Equivalent on September 21, 1981. The device falls under product code HIL (Tampon, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5460. Playtex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1981
Date Received
September 3, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tampon, Menstrual, Scented, Scented-Deodorized
Device Class
Class II
Regulation Number
884.5460
Review Panel
OB
Submission Type

A scented or scented-deodorized menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.

Other clearances by Playtex, Inc.

  • K120245 — PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS (June 21, 2012)
  • K980478 — PLAYTEX TAMPONS #03498 (April 3, 1998)
  • K971174 — PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS (May 21, 1997)
  • K944064 — PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894 (February 9, 1995)
  • K941044 — PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194 (July 27, 1994)
  • K942418 — PLAYTEX TAMPONS MODEL 13794 (July 8, 1994)
  • K881057 — PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER (March 22, 1988)
  • K874509 — PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL (January 7, 1988)
  • K843551 — PLAYTEX BABY POWDER DEODORANT TAMPONS (December 3, 1984)
  • K841155 — DEODORANT SLENDER REG. TAMPONS (March 19, 1984)

Other clearances for product code HIL

  • K132208 — ONTEX AND OTHERS PROPRIETARY NAMES (April 10, 2014)
  • K132819 — PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS (October 9, 2013)
  • K120245 — PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS (June 21, 2012)
  • K111684 — PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD (February 3, 2012)
  • K081555 — TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED (June 27, 2008)
  • K073662 — PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS (January 17, 2008)
  • K072376 — PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS (December 12, 2007)
  • K070745 — MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK (April 13, 2007)
  • K060981 — PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS (May 9, 2006)
  • K051446 — FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS (July 14, 2005)

FDA data resources