510(k) K072376

PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS by Playtex Products, Inc. — Product Code HIL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 12, 2007
Date Received: August 24, 2007
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 Products, Inc.

K073662 — PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS (January 17, 2008)
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)
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)
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)
K050067 — FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS (February 1, 2005)