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510(k) K070745

MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS by Playtex Products, Inc. — Product Code HIL

K070745 is an FDA 510(k) premarket notification submitted by Playtex Products, Inc. for the device "MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS". The FDA issued a decision of Substantially Equivalent on April 13, 2007. 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
April 13, 2007
Date Received
March 19, 2007
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)
  • 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)
  • K022882 — MODIFICATION TO PLAYTEX TAMPONS #24002 (September 16, 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)
  • 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)
  • K050067 — FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS (February 1, 2005)

FDA data resources