Cleared Special

PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS

K073662 · Playtex Products, Inc. · Obstetrics & Gynecology

Jan 2008

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K073662 is an FDA 510(k) clearance for the PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS, a Tampon, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HIL), submitted by Playtex Products, Inc. (Dover, US). The FDA issued a Cleared decision on January 17, 2008, 22 days after receiving the submission on December 26, 2007. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K073662 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 2007
Decision Date	January 17, 2008
Days to Decision	22 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.