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510(k) K914438

PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS by Playtex Family Products, Inc. — Product Code HIL

K914438 is an FDA 510(k) premarket notification submitted by Playtex Family Products, Inc. for the device "PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS". The FDA issued a decision of Substantially Equivalent on January 2, 1992. The device falls under product code HIL (Tampon, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5460. Playtex Family Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1992
Date Received
October 4, 1991
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 Family Products, Inc.

  • K941196 — PLATEX TAMPONS MODEL NUMBER 07094 (April 19, 1994)
  • K940821 — PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED (March 25, 1994)
  • K935276 — PLAYTEX NON-DEODORANT TAMPONS, PLAYTEX DEODORANT TAMPONS (March 7, 1994)
  • K932909 — PLAYTEX ULTIMATES TAMPONS (March 7, 1994)
  • K936189 — PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND SCENTED (March 7, 1994)
  • K934083 — PLAYTEX ULTIMATES TAMPONS (March 7, 1994)
  • K932907 — PLAYTEX ULTIMATES TAMPONS (March 7, 1994)
  • K922834 — TAMPONS, NATURAL ODOR PROT. VARIOUS ABSORBENCY (September 1, 1993)
  • K924279 — PLAYTEX FLUSHABLE TAMPONS, REGULAR, SUPER, SUPER + (May 21, 1993)
  • K912002 — PLAYTEX NON-DEODORANT/DEODORANT TAMPONS (August 12, 1991)

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