Cleared Special

PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS

K132819 · Playtex Manufacturing, Inc. · Obstetrics & Gynecology

Oct 2013

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K132819 is an FDA 510(k) clearance for the PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS, a Tampon, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HIL), submitted by Playtex Manufacturing, Inc. (Allendale, US). The FDA issued a Cleared decision on October 9, 2013, 30 days after receiving the submission on September 9, 2013. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K132819 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 09, 2013
Decision Date	October 09, 2013
Days to Decision	30 days
Submission Type	Special
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.