Cleared Traditional

GLADRAGS COTTON MENSTRUAL PAD

K980395 · Keepers!, Inc. · Obstetrics & Gynecology

Apr 1998

Decision

73d

Days

Class 1

Risk

About This 510(k) Submission

K980395 is an FDA 510(k) clearance for the GLADRAGS COTTON MENSTRUAL PAD, a Pad, Menstrual, Unscented (Class I — General Controls, product code HHD), submitted by Keepers!, Inc. (Portland, US). The FDA issued a Cleared decision on April 16, 1998, 73 days after receiving the submission on February 2, 1998. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5435.

Submission Details

510(k) Number	K980395 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 1998
Decision Date	April 16, 1998
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement

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.