Cleared Traditional

K861357 - WHENEVER UNSCENTED PANTY SHIELD

K861357 is the FDA 510(k) clearance for WHENEVER UNSCENTED PANTY SHIELD by Marcal Paper Mills, Inc.. It is a Class 1 Obstetrics & Gynecology device (product code HHD) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K861357 · Marcal Paper Mills, Inc. · Obstetrics & Gynecology device
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Apr 1986
Decision
13d
Days
Class 1
Risk

K861357 is an FDA 510(k) clearance for the WHENEVER UNSCENTED PANTY SHIELD. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Marcal Paper Mills, Inc. (Elmwood Park, US). The FDA issued a Cleared decision on April 23, 1986 after a review of 13 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.

View all Marcal Paper Mills, Inc. devices

Submission Details

510(k) Number K861357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1986
Decision Date April 23, 1986
Days to Decision 13 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d faster than avg
Panel avg: 160d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 54
Devices cleared under the same product code (HHD) and FDA review panel - the closest regulatory comparables to K861357.
MODIFIED SUPER MAXITHINS PADS, UNSCENTED
K862679 · Tambrands, Inc. · Aug 1986
MODIFIED REGULAR MAXITHINS PADS, UNSCENTED
K862680 · Tambrands, Inc. · Aug 1986
KOTEX PROFILE SHAPED MAXI PAD
K861902 · Kimberly-Clark Corp. · Jun 1986
KOTEX OVERNITE
K860587 · Kimberly-Clark Corp. · Mar 1986
BELIEVE HEAVY FLOW PROTECTION LABIAL PADS
K853630 · Kimberly-Clark Corp. · Nov 1985
UNSCENTED ALWAYS PANTILINERS
K852985 · Procter & Gamble Mfg. Co. · Aug 1985