Cleared Traditional

K932731 - BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN

K932731 is an FDA 510(k) clearance for BARRIER* EXTRA PROTECTION PLUS SURGICAL..., manufactured by Johnson & Johnson Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FYE cleared through the Traditional 510(k) pathway after a 308-day FDA review.

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.

FDA 510(k) Submission Details - K932731

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 115d · This submission: 308d
Pathway characteristics
Predicate-based equivalence.

FYE Device Classification - Class 1, General Controls

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.

Regulatory Peers - FYE Dress, Surgical

Devices cleared under the same product code (FYE) and FDA review panel - the closest regulatory comparables to K932731.
SURGICAL GOWN
K912790 · Unicor Federal Dept. of Justice · Sep 1991
PROTEKT GLOVES
K910920 · Intermedics Orthopedics · May 1991
LIFELINER SURGICAL GLOVE
K910941 · Depuy-Raynham · May 1991
STERILE SURGICAL GOWN
K895667 · Clinitech, Inc. · Oct 1989
VARIOUS DISPOSABLE SURGICAL GARMENTS
K895235 · Protect Corp. of Indiana, Inc. · Sep 1989
CLOTHINGUARD
K894760 · Barrier Concepts, Inc. · Aug 1989
K932731 · BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN
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