Cleared Traditional

K821375 - DEODORANT SURE & NATURAL MAXISHIELDS

K821375 is the FDA 510(k) clearance for DEODORANT SURE & NATURAL MAXISHIELDS by Personal Products Co.. It is a Class 2 Obstetrics & Gynecology device (product code HHL) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K821375 · Personal Products Co. · Obstetrics & Gynecology device
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Jun 1982
Decision
22d
Days
Class 2
Risk

K821375 is an FDA 510(k) clearance for the DEODORANT SURE & NATURAL MAXISHIELDS. Classified as Pad, Menstrual, Scented, Scented-deodorized (product code HHL), Class II - Special Controls.

Submitted by Personal Products Co. (Walker, US). The FDA issued a Cleared decision on June 1, 1982 after a review of 22 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 Personal Products Co. devices

Submission Details

510(k) Number K821375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1982
Decision Date June 01, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d faster than avg
Panel avg: 160d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 37
Devices cleared under the same product code (HHL) and FDA review panel - the closest regulatory comparables to K821375.
CAREFREE * PANTY SHIELDS-REG/DEOR
K832382 · Johnson & Johnson Professionals, Inc. · Aug 1983
PANTY-LINERS SCENTED
K830144 · Procter & Gamble Mfg. Co. · Jan 1983
SCENTED MENSTRUAL PADS
K823478 · Procter & Gamble Mfg. Co. · Jan 1983
SCENTED MENSTRUAL PADS
K812403 · Procter & Gamble Mfg. Co. · Sep 1981
SCENTED MENSTRUAL PADS
K811868 · Procter & Gamble Mfg. Co. · Jul 1981
KOTEX LIGHTDAYS DEODORANT PANTILINERS
K802277 · Kimberly-Clark Corp. · Oct 1980