Cleared Traditional

ALWAYS SCENTED OR SCENTED DEODORIZED MENSTRUAL PAD

K884429 · Procter & Gamble Co. · Obstetrics & Gynecology

Dec 1988

Decision

43d

Days

Class 2

Risk

About This 510(k) Submission

K884429 is an FDA 510(k) clearance for the ALWAYS SCENTED OR 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 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 884.5425.

Submission Details

510(k) Number	K884429 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	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).