Cleared Traditional

K823239 - SURE & NATURAL MAXISHIELDS

K823239 is the FDA 510(k) clearance for SURE & NATURAL MAXISHIELDS by Personal Products Co.. It is a Class 1 Obstetrics & Gynecology device (product code HHD) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K823239 · Personal Products Co. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1982
Decision
45d
Days
Class 1
Risk

K823239 is an FDA 510(k) clearance for the SURE & NATURAL MAXISHIELDS. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Personal Products Co. (Walker, US). The FDA issued a Cleared decision on December 16, 1982 after a review of 45 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 Personal Products Co. devices

Submission Details

510(k) Number K823239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1982
Decision Date December 16, 1982
Days to Decision 45 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
115d faster than avg
Panel avg: 160d · This submission: 45d
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 53
Devices cleared under the same product code (HHD) and FDA review panel - the closest regulatory comparables to K823239.
PANTY-LINERS UNSCENTED
K830145 · Procter & Gamble Mfg. Co. · Jan 1983
UNSCENTED MENSTRUAL PADS
K823477 · Procter & Gamble Mfg. Co. · Jan 1983
NEW FREEDOM THIN UNSCENTED MAXI PADS
K823241 · Kimberly-Clark Corp. · Dec 1982
U.V.A.C. CURETTES
K822756 · American Hospital Supply Corp. · Sep 1982
CAREFREE PANTY SHIELDS
K820522 · Personal Products Co. · Mar 1982
UNSCENTED MENSTRUAL PADS
K812402 · Procter & Gamble Mfg. Co. · Sep 1981