Cleared Traditional

K971174 - PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS
(FDA 510(k) Clearance)

K971174 · Playtex, Inc. · Obstetrics & Gynecology

May 1997

Decision

51d

Days

Class 2

Risk

K971174 is an FDA 510(k) clearance for the PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS. This device is classified as a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB).

Submitted by Playtex, Inc. (Paramus, US). The FDA issued a Cleared decision on May 21, 1997, 51 days after receiving the submission on March 31, 1997.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5470. An Unscented 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..

Submission Details

510(k) Number	K971174 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 1997
Decision Date	May 21, 1997
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	HEB — Tampon, Menstrual, Unscented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5470
Definition	An Unscented 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.