Cleared Traditional

ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD

K913237 · Procter & Gamble Co. · Obstetrics & Gynecology

Sep 1991

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K913237 is an FDA 510(k) clearance for the ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD, a Pad, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HHL), submitted by Procter & Gamble Co. (Cincinnati, US). The FDA issued a Cleared decision on September 23, 1991, 63 days after receiving the submission on July 22, 1991. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5425.

Submission Details

510(k) Number	K913237 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 1991
Decision Date	September 23, 1991
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement

Device Classification

Product Code	HHL — Pad, Menstrual, Scented, Scented-deodorized
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5425
Definition	Scented Or Scented-deodorized Menstrual Pads Used To Absorb Menstrual Or Other Vaginal Discharge, Including Those Intended As Intralabial Pads Or Reusable Menstrual Pads. These Are Made With Materials That Do Not Meet The Requirements For Class 1 Per 21 Cfr 884.5425(b).