FXP · Class I · 21 CFR 878.4040

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

Leading manufacturers include Abco Dealers, Inc., Procter & Gamble Mfg. Co. and Tecnol New Jersey Wound Care, Inc..

36
Total
36
Cleared
88d
Avg days
1976
Since

FDA 510(k) Cleared Cover, Shoe, Operating-room Devices (Product Code FXP)

36 devices
1–24 of 36
Cleared Jan 13, 1998
PRIMED SHOE COVERS, PRIMED HEAD COVERS
K971076
Primeline Medical Products, Inc.
General Hospital · 295d
Cleared Jul 10, 1997
FAR-EAST SHOE COVERS
K971191
Far East Science & Technology Development Co., Ltd.
General Hospital · 101d
Cleared Mar 27, 1997
CONVERTORS IMPERVIOUS SHOE COVERS
K970815
Allegiance Healthcare Corp.
General Hospital · 21d
Cleared Dec 30, 1996
SHOE COVER, NON-STERILE
K961342
Copioumed Intl., Inc.
General Hospital · 285d
Cleared Nov 19, 1996
FLUID BARRIER BOOT KNEE & ANKLE-HIGH
K955835
Instrument Makar, Inc.
General Hospital · 329d
Cleared Jan 02, 1995
OREX SHOE COVERS
K943034
Thantex Specialties, Inc.
General Hospital · 189d
Cleared Jan 29, 1993
STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS
K914702
Depuy, Inc.
General Hospital · 469d
Cleared Sep 12, 1989
DISPOSABLE SHOE COVER
K894383
American Threshold Industries, Inc.
General Hospital · 57d
Cleared Jun 23, 1989
TECNOL GAITERS PRODUCT NUMBER 47725-010
K893702
Tecnol New Jersey Wound Care, Inc.
General Hospital · 36d
Cleared Jun 15, 1988
TECNOL TIGER PAWS PRODUCT NUMBER 47705-010
K882128
Tecnol New Jersey Wound Care, Inc.
General Hospital · 26d
Cleared Aug 04, 1987
NON-SKID SHOE COVERS
K872797
Abco Dealers, Inc.
General Hospital · 20d
Cleared Jan 12, 1987
COVER, SHOE OPERATING ROOM
K865023
Ulti-Med Intl., Inc.
General Hospital · 20d
Cleared Oct 30, 1986
NONCONDUCTIVE SHOE COVER
K864026
Kimberly-Clark Corp.
General Hospital · 15d
Cleared Aug 01, 1986
DISPOSABLE SHOE COVERS AND NURSES CAPS
K862726
Abco Dealers, Inc.
General Hospital · 14d
Cleared Apr 30, 1985
OVERSHOES (SURCHAUSSURES
K851554
Roseburg SA
General Hospital · 14d
Cleared Oct 31, 1984
PHARMA-PLAST SINGLE USE OVERSHOES
K843475
Zimmar Consulting , Ltd.
General Hospital · 55d
Cleared Apr 27, 1983
MICRO-MITT
K830821
CooperVision, Inc.
General Hospital · 43d
Cleared Aug 04, 1980
NON-CONDUCTIVE SHOE COVERS
K801616
Procter & Gamble Mfg. Co.
General Hospital · 20d
Cleared Aug 04, 1980
CONDUCTIVE SHOE COVERS
K801617
Procter & Gamble Mfg. Co.
General Hospital · 20d
Cleared Apr 16, 1980
SHIELD PERFECT FIT
K800528
American Convertors Div., American Pharmaseal
General Hospital · 40d
Cleared May 09, 1978
SHOE COVERS
K780590
Abco Dealers, Inc.
General Hospital · 29d
Cleared Nov 02, 1976
BARNER SHOE COVERS & COVERBOOTS
K760779
Surgikos, Inc.
General Hospital · 28d

About Product Code FXP - Regulatory Context