Cleared Traditional

K931145 - NON-STERILE ISOLATION GOWN

K931145 is an FDA 510(k) clearance for NON-STERILE ISOLATION GOWN, manufactured by Amsco Sterile Recoveries, Inc.. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 462-day FDA review.

K931145 · Amsco Sterile Recoveries, Inc. · General Hospital
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Jun 1994
Decision
462d
Days
Class 2
Risk

K931145 is an FDA 510(k) clearance for the NON-STERILE ISOLATION GOWN. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Amsco Sterile Recoveries, Inc. (Clearwater, US). The FDA issued a Cleared decision on June 10, 1994 after a review of 462 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Amsco Sterile Recoveries, Inc. devices

FDA 510(k) Submission Details - K931145

510(k) Number K931145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1993
Decision Date June 10, 1994
Days to Decision 462 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
333d slower than avg
Panel avg: 129d · This submission: 462d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYC Device Classification - Class 2, Special Controls

Product Code FYC Gown, Isolation, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FYC Gown, Isolation, Surgical

All 33
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K931145.
Medline Non-Surgical Isolation Gown-
K160471 · Medline Industries, Inc. · Jan 2017
CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
K982369 · Allegiance Healthcare Corp. · Aug 1998
BUSE STAFF PROTECTION GOWNS AND KITS
K941845 · Busse Hospital Disposables, Inc. · May 1995
ISOLATION GOWN
K874888 · Sage Products, Inc. · Dec 1987
CONTROL COVER GOWN
K840229 · Kimberly-Clark Corp. · Mar 1984
BARRIER PLUS SURGEON GOWNS
K801162 · American Hospital Supply Corp. · May 1980