FXP · Class I · 21 CFR 878.4040

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

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

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 Mar 27, 1997
CONVERTORS IMPERVIOUS SHOE COVERS
K970815
Allegiance Healthcare Corp.
General Hospital · 21d
Cleared Jan 29, 1993
STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS
K914702
Depuy, Inc.
General Hospital · 469d
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 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 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 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