Cover, Shoe, Operating-Room

FDA product code FXP · 36 cleared devices

Class 1 General, Plastic Surgery

Regulation: 21 CFR 878.4040
Review panel: HO
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-11-02 – 1998-01-13

FXP 1998-01-13

PRIMED SHOE COVERS, PRIMED HEAD COVERS

Applicant Primeline Medical Products, Inc.

K number K971076

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FXP 1997-07-10

FAR-EAST SHOE COVERS

Applicant Far East Science & Technology Development Co., Ltd.

K number K971191

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FXP 1997-03-27

CONVERTORS IMPERVIOUS SHOE COVERS

Applicant Allegiance Healthcare Corp.

K number K970815

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FXP 1996-12-30

SHOE COVER, NON-STERILE

Applicant Copioumed Intl., Inc.

K number K961342

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FXP 1996-11-19

FLUID BARRIER BOOT KNEE & ANKLE-HIGH

Applicant Instrument Makar, Inc.

K number K955835

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FXP 1995-10-23

NIOMED NON-SKID SHOE COVERS

Applicant Amerasia Corp.

K number K952937

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FXP 1995-10-23

NIOMED SHOE COVERS

Applicant Amerasia Corp.

K number K952897

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FXP 1995-01-02

OREX SHOE COVERS

Applicant Thantex Specialties, Inc.

K number K943034

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FXP 1994-03-29

KAPPLER PRO/VENT BOOT

Applicant Kappler, Inc.

K number K932738

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FXP 1993-07-09

REUSABLE LIQUIDPROOF BOOTIE

Applicant Amsco Sterile Recoveries, Inc.

K number K925815

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FXP 1993-01-29

STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS

Applicant Depuy, Inc.

K number K914702

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FXP 1991-10-04

DISPOSABLE SHOE COVER

Applicant Gem Nonwovews, Inc.

K number K913628

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FXP 1989-09-12

DISPOSABLE SHOE COVER

Applicant American Threshold Industries, Inc.

K number K894383

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FXP 1989-06-23

TECNOL GAITERS PRODUCT NUMBER 47725-010

Applicant Tecnol New Jersey Wound Care, Inc.

K number K893702

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FXP 1988-09-15

SKID RESISTANT, LONG LASTING SHOE COVERS

Applicant James River Corp.

K number K883657

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FXP 1988-06-23