Cleared Traditional

ALWAYS UNSCENTED MENSTRUAL PADS

K884428 · Procter & Gamble Co. · Obstetrics & Gynecology

Dec 1988

Decision

43d

Days

Class 1

Risk

About This 510(k) Submission

K884428 is an FDA 510(k) clearance for the ALWAYS UNSCENTED MENSTRUAL PADS, a Pad, Menstrual, Unscented (Class I — General Controls, product code HHD), submitted by Procter & Gamble Co. (Cincinnati, US). The FDA issued a Cleared decision on December 2, 1988, 43 days after receiving the submission on October 20, 1988. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5435.

Submission Details

510(k) Number	K884428 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 20, 1988
Decision Date	December 02, 1988
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—

Device Classification

Product Code	HHD — Pad, Menstrual, Unscented
Device Class	Class I — General Controls
CFR Regulation	21 CFR 884.5435
Definition	An Unscented Menstrual Pad Which Is Used To Absorb Menstrual Fluid Or Other Vaginal Discharge And Is Made Of Common Cellulosic And Synthetic Material With An Established Safety Profile.