Cleared Traditional

K945223 - OREX ISOLATION GOWN

K945223 is an FDA 510(k) clearance for OREX ISOLATION GOWN, manufactured by Thantex Specialties, Inc.. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K945223 · Thantex Specialties, Inc. · General Hospital
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Apr 1995
Decision
181d
Days
Class 2
Risk

K945223 is an FDA 510(k) clearance for the OREX ISOLATION GOWN. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Thantex Specialties, Inc. (Herndon, US). The FDA issued a Cleared decision on April 25, 1995 after a review of 181 days - an extended review cycle.

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

View all Thantex Specialties, Inc. devices

FDA 510(k) Submission Details - K945223

510(k) Number K945223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1994
Decision Date April 25, 1995
Days to Decision 181 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 129d · This submission: 181d
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 35
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K945223.
Cardinal Health Isolation Gown
K160339 · Cardinal Health200, LLC · Jul 2016
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
MAXIMUM CONTROL GOWN
K874318 · Ulti-Med Intl., Inc. · Dec 1987
CONTROL COVER GOWN
K840229 · Kimberly-Clark Corp. · Mar 1984