Cleared Traditional

K953878 - BOUFFANT CAP

K953878 is the FDA 510(k) clearance for BOUFFANT CAP by American Threshold Industries, Inc.. It is a Class 1 General & Plastic Surgery device (product code FYF) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K953878 · American Threshold Industries, Inc. · General & Plastic Surgery device
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Jan 1996
Decision
142d
Days
Class 1
Risk

K953878 is an FDA 510(k) clearance for the BOUFFANT CAP. Classified as Cap, Surgical (product code FYF), Class I - General Controls.

Submitted by American Threshold Industries, Inc. (Enka, US). The FDA issued a Cleared decision on January 5, 1996 after a review of 142 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all American Threshold Industries, Inc. devices

Submission Details

510(k) Number K953878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1995
Decision Date January 05, 1996
Days to Decision 142 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 115d · This submission: 142d
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 10
Devices cleared under the same product code (FYF) and FDA review panel - the closest regulatory comparables to K953878.
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
BOUNDARY HEADWEAR
K831357 · Procter & Gamble Mfg. Co. · Jun 1983
DISPOSABLE SURGERY CAPS & HOODS
K810199 · Anago, Inc. · Feb 1981
DISPOSABLE NURSES CAP
K802186 · Anago, Inc. · Sep 1980