Cleared Traditional

K971076 - PRIMED SHOE COVERS, PRIMED HEAD COVERS

K971076 is an FDA 510(k) clearance for PRIMED SHOE COVERS, manufactured by Primeline Medical Products, Inc.. The device is a Class 1 General Hospital device with product code FXP cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K971076 · Primeline Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
295d
Days
Class 1
Risk

K971076 is an FDA 510(k) clearance for the PRIMED SHOE COVERS, PRIMED HEAD COVERS. Classified as Cover, Shoe, Operating-room (product code FXP), Class I - General Controls.

Submitted by Primeline Medical Products, Inc. (Alberta, CA). The FDA issued a Cleared decision on January 13, 1998 after a review of 295 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 Primeline Medical Products, Inc. devices

FDA 510(k) Submission Details - K971076

510(k) Number K971076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1997
Decision Date January 13, 1998
Days to Decision 295 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
166d slower than avg
Panel avg: 129d · This submission: 295d
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 20
Devices cleared under the same product code (FXP) and FDA review panel - the closest regulatory comparables to K971076.
FAR-EAST SHOE COVERS
K971191 · Far East Science & Technology Development Co., Ltd. · Jul 1997
CONVERTORS IMPERVIOUS SHOE COVERS
K970815 · Allegiance Healthcare Corp. · Mar 1997
FLUID BARRIER BOOT KNEE & ANKLE-HIGH
K955835 · Instrument Makar, Inc. · Nov 1996
OREX SHOE COVERS
K943034 · Thantex Specialties, Inc. · Jan 1995
STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS
K914702 · Depuy, Inc. · Jan 1993
DISPOSABLE SHOE COVER
K894383 · American Threshold Industries, Inc. · Sep 1989