Cleared Traditional

CAREFREE PANTYLINERS

K961119 · Personal Products Co. · Obstetrics & Gynecology

Apr 1996

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K961119 is an FDA 510(k) clearance for the CAREFREE PANTYLINERS, a Pad, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HHL), submitted by Personal Products Co. (Skillman, US). The FDA issued a Cleared decision on April 17, 1996, 27 days after receiving the submission on March 21, 1996. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5425.

Submission Details

510(k) Number	K961119 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 21, 1996
Decision Date	April 17, 1996
Days to Decision	27 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

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).