Cleared Traditional

K962953 - DEODORANT PANTY SHIELD

K962953 is an FDA 510(k) clearance for DEODORANT PANTY SHIELD, manufactured by Paragon Trade Brands, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHL cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K962953 · Paragon Trade Brands, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Oct 1996
Decision
72d
Days
Class 2
Risk

K962953 is an FDA 510(k) clearance for the DEODORANT PANTY SHIELD. Classified as Pad, Menstrual, Scented, Scented-deodorized (product code HHL), Class II - Special Controls.

Submitted by Paragon Trade Brands, Inc. (Gaffney, US). The FDA issued a Cleared decision on October 10, 1996 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5425 - 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 Paragon Trade Brands, Inc. devices

FDA 510(k) Submission Details - K962953

510(k) Number K962953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1996
Decision Date October 10, 1996
Days to Decision 72 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: 160d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHL Device Classification - Class 2, Special Controls

Product Code HHL Pad, Menstrual, Scented, Scented-deodorized
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HHL Pad, Menstrual, Scented, Scented-deodorized

All 44
Devices cleared under the same product code (HHL) and FDA review panel - the closest regulatory comparables to K962953.
DEODORANT MAXI PAD
K962954 · Paragon Trade Brands, Inc. · Oct 1996
DEODORANT PANTY LINER
K962962 · Paragon Trade Brands, Inc. · Oct 1996
CAREFREE PANTYLINERS
K961119 · Personal Products Co. · Apr 1996
ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD
K913237 · Procter & Gamble Co. · Sep 1991
ALWAYS, UNSCENTED MENSTRUAL PAD
K913238 · Procter & Gamble Co. · Sep 1991
TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO
K891473 · Tambrands, Inc. · Jun 1989