Cleared Traditional

BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN (K932731) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K932731 · Johnson & Johnson Medical, Inc. · General & Plastic Surgery device
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Apr 1994
Decision
308d
Days
Class 1
Risk

K932731 is an FDA 510(k) clearance for the BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN. Classified as Dress, Surgical (product code FYE), Class I - General Controls.

Submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on April 11, 1994 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K932731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1993
Decision Date April 11, 1994
Days to Decision 308 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
193d slower than avg
Panel avg: 115d · This submission: 308d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FYE Dress, 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.