Home / 510(k) Clearances / K022882

510(k) K022882

MODIFICATION TO PLAYTEX TAMPONS #24002 by Playtex Products, Inc. — Product Code HIL

K022882 is an FDA 510(k) premarket notification submitted by Playtex Products, Inc. for the device "MODIFICATION TO PLAYTEX TAMPONS #24002". The FDA issued a decision of Substantially Equivalent on September 16, 2002. The device falls under product code HIL (Tampon, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5460. Playtex Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2002
Date Received
August 30, 2002
Clearance Type
Special
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 Products, Inc.

  • 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)
  • K061013 — PLAYTEX EMBRACE PETITE BREAST PUMP (August 15, 2006)
  • K060981 — PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS (May 9, 2006)
  • K032636 — PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (N (November 14, 2003)
  • K022594 — PLAYTEX BREAST PUMP (November 1, 2002)
  • K020200 — PLAYTEX DEODORANT TAMPONS, MODEL 34802 (March 13, 2002)
  • K020201 — PLAYTEX DEODORANT TAMPONS, MODEL 34902 (March 12, 2002)
  • K020202 — PLAYTEX DEODORANT TAMPONS, MODEL 34702 (March 12, 2002)

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