Cleared Traditional

K831357 - BOUNDARY HEADWEAR

K831357 is the FDA 510(k) clearance for BOUNDARY HEADWEAR by Procter & Gamble Mfg. Co.. It is a Class 1 General & Plastic Surgery device (product code FYF) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K831357 · Procter & Gamble Mfg. Co. · General & Plastic Surgery device
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Jun 1983
Decision
37d
Days
Class 1
Risk

K831357 is an FDA 510(k) clearance for the BOUNDARY HEADWEAR. Classified as Cap, Surgical (product code FYF), Class I - General Controls.

Submitted by Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 37 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4040 - the FDA general and plastic surgery 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 Procter & Gamble Mfg. Co. devices

Submission Details

510(k) Number K831357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1983
Decision Date June 02, 1983
Days to Decision 37 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 115d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FYF Cap, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
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 - FYF Cap, Surgical

All 9
Devices cleared under the same product code (FYF) and FDA review panel - the closest regulatory comparables to K831357.
KIMBERLY-CLARK FULL COVERAGE HOOD
K875261 · Kimberly-Clark Corp. · Jan 1988
TECNOL SURGEON'S CAP
K873830 · Tecnol New Jersey Wound Care, Inc. · Oct 1987
BOUFFANT-STYLE SURGICAL CAP
K863359 · Kimberly-Clark Corp. · Sep 1986
DISPOSABLE SURGERY CAPS & HOODS
K810199 · Anago, Inc. · Feb 1981
DISPOSABLE NURSES CAP
K802186 · Anago, Inc. · Sep 1980
CAP, CLARION NURSES, STYLE BOUFFANT 21
K770258 · Sherwood Medical Industries · Mar 1977