Cleared Traditional

PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS

K971547 · Playtex Products, Inc. · Obstetrics & Gynecology

Jun 1997

Decision

52d

Days

Class 2

Risk

About This 510(k) Submission

K971547 is an FDA 510(k) clearance for the PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS, a Tampon, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HIL), submitted by Playtex Products, Inc. (Paramus, US). The FDA issued a Cleared decision on June 19, 1997, 52 days after receiving the submission on April 28, 1997. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K971547 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 1997
Decision Date	June 19, 1997
Days to Decision	52 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.