Cleared Traditional

K980395 - GLADRAGS COTTON MENSTRUAL PAD

K980395 is an FDA 510(k) clearance for GLADRAGS COTTON MENSTRUAL PAD, manufactured by Keepers!, Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HHD cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K980395 · Keepers!, Inc. · Obstetrics & Gynecology device
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Apr 1998
Decision
73d
Days
Class 1
Risk

K980395 is an FDA 510(k) clearance for the GLADRAGS COTTON MENSTRUAL PAD. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Keepers!, Inc. (Portland, US). The FDA issued a Cleared decision on April 16, 1998 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5435 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K980395

510(k) Number K980395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 161d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

HHD Device Classification - Class 1, General Controls

Product Code HHD Pad, Menstrual, Unscented
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HHD Pad, Menstrual, Unscented

All 106
Devices cleared under the same product code (HHD) and FDA review panel - the closest regulatory comparables to K980395.
ALWAYS DUETS
K012629 · Procter & Gamble Co. · Oct 2001
ENVIVE MINIFORMS
K003843 · Procter & Gamble Co. · Feb 2001
UNSCENTED INTERLABIAL MENSTRUAL PAD
K993870 · Procter & Gamble Co. · Jan 2000
FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS)
K953470 · Mediquip, Inc. · Nov 1995
UNSCENTED MENSTRUAL PAD
K953633 · Tendasoft, Inc. · Nov 1995
UNSCENTED CURVED ULTRATHIN MAXI PADS
K953667 · Paragon Trade Brands, Inc. · Nov 1995
K980395 · GLADRAGS COTTON MENSTRUAL PAD
Download PDF Keepers!, Inc.