Cleared Traditional

PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS

K120245 · Playtex, Inc. · Obstetrics & Gynecology

Jun 2012

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K120245 is an FDA 510(k) clearance for the PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS, a Tampon, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HIL), submitted by Playtex, Inc. (Allendale, US). The FDA issued a Cleared decision on June 21, 2012, 146 days after receiving the submission on January 27, 2012. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K120245 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 27, 2012
Decision Date	June 21, 2012
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	HIL — Tampon, Menstrual, Scented, Scented-deodorized
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5460
Definition	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.