Cleared Special

PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS

K060981 · Playtex Products, Inc. · Obstetrics & Gynecology

May 2006

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K060981 is an FDA 510(k) clearance for the PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS, a Tampon, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HIL), submitted by Playtex Products, Inc. (Allendale, US). The FDA issued a Cleared decision on May 9, 2006, 29 days after receiving the submission on April 10, 2006. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K060981 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 2006
Decision Date	May 09, 2006
Days to Decision	29 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.