Cleared Traditional

K943034 - OREX SHOE COVERS

K943034 is an FDA 510(k) clearance for OREX SHOE COVERS, manufactured by Thantex Specialties, Inc.. The device is a Class 1 General Hospital device with product code FXP cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K943034 · Thantex Specialties, Inc. · General Hospital
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Jan 1995
Decision
189d
Days
Class 1
Risk

K943034 is an FDA 510(k) clearance for the OREX SHOE COVERS. Classified as Cover, Shoe, Operating-room (product code FXP), Class I - General Controls.

Submitted by Thantex Specialties, Inc. (Herndon, US). The FDA issued a Cleared decision on January 2, 1995 after a review of 189 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 - K943034

510(k) Number K943034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1994
Decision Date January 02, 1995
Days to Decision 189 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
60d slower than avg
Panel avg: 129d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

FXP Device Classification - Class 1, General Controls

Product Code FXP Cover, Shoe, Operating-room
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 - FXP Cover, Shoe, Operating-room

All 15
Devices cleared under the same product code (FXP) and FDA review panel - the closest regulatory comparables to K943034.
CONVERTORS IMPERVIOUS SHOE COVERS
K970815 · Allegiance Healthcare Corp. · Mar 1997
FLUID BARRIER BOOT KNEE & ANKLE-HIGH
K955835 · Instrument Makar, Inc. · Nov 1996
STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS
K914702 · Depuy, Inc. · Jan 1993
TECNOL GAITERS PRODUCT NUMBER 47725-010
K893702 · Tecnol New Jersey Wound Care, Inc. · Jun 1989
TECNOL TIGER PAWS PRODUCT NUMBER 47705-010
K882128 · Tecnol New Jersey Wound Care, Inc. · Jun 1988
NON-SKID SHOE COVERS
K872797 · Abco Dealers, Inc. · Aug 1987