Cleared Traditional

K913628 - DISPOSABLE SHOE COVER

K913628 is an FDA 510(k) clearance for DISPOSABLE SHOE COVER, manufactured by Gem Nonwovews, Inc.. The device is a Class 1 General Hospital device with product code FXP cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K913628 · Gem Nonwovews, Inc. · General Hospital
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Oct 1991
Decision
50d
Days
Class 1
Risk

K913628 is an FDA 510(k) clearance for the DISPOSABLE SHOE COVER. Classified as Cover, Shoe, Operating-room (product code FXP), Class I - General Controls.

Submitted by Gem Nonwovews, Inc. (Huntsville, US). The FDA issued a Cleared decision on October 4, 1991 after a review of 50 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gem Nonwovews, Inc. devices

FDA 510(k) Submission Details - K913628

510(k) Number K913628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1991
Decision Date October 04, 1991
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
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 22
Devices cleared under the same product code (FXP) and FDA review panel - the closest regulatory comparables to K913628.
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
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