Product Code: FXP FDA class 1 21 CFR 878.4040

Cover, Shoe, Operating-Room

General, Plastic Surgery

An operating room shoe cover is a disposable or reusable protective covering worn over footwear in surgical environments to maintain the sterility of the operating room and reduce contamination risk. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FXP, regulated under 21 CFR 878.4040, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

282

Registration Numbers

282

Unique Applicants

Years Active

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Basic Information

Product Code: FXP
Device Class: FDA class 1
Regulation Number: 878.4040
Medical Specialty: General, Plastic Surgery
Review Panel: HO
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 36 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K971076	PRIMED SHOE COVERS, PRIMED HEAD COVERS	Jan 13, 1998	Substantially Equivalent	Primeline Medical Products, Inc.
K971191	FAR-EAST SHOE COVERS	Jul 10, 1997	Substantially Equivalent	Far East Science & Technology Development Co., Ltd.
K970815	CONVERTORS IMPERVIOUS SHOE COVERS	Mar 27, 1997	Substantially Equivalent	Allegiance Healthcare Corp.
K961342	SHOE COVER, NON-STERILE	Dec 30, 1996	Substantially Equivalent	Copioumed Intl., Inc.
K955835	FLUID BARRIER BOOT KNEE & ANKLE-HIGH	Nov 19, 1996	Substantially Equivalent	Instrument Makar, Inc.
K952937	NIOMED NON-SKID SHOE COVERS	Oct 23, 1995	Substantially Equivalent	Amerasia Corp.
K952897	NIOMED SHOE COVERS	Oct 23, 1995	Substantially Equivalent	Amerasia Corp.
K943034	OREX SHOE COVERS	Jan 02, 1995	Substantially Equivalent	Thantex Specialties, Inc.
K932738	KAPPLER PRO/VENT BOOT	Mar 29, 1994	Substantially Equivalent	Kappler, Inc.
K925815	REUSABLE LIQUIDPROOF BOOTIE	Jul 09, 1993	Substantially Equivalent	Amsco Sterile Recoveries, Inc.
K914702	STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS	Jan 29, 1993	Substantially Equivalent	Depuy, Inc.
K913628	DISPOSABLE SHOE COVER	Oct 04, 1991	Substantially Equivalent	Gem Nonwovews, Inc.
K894383	DISPOSABLE SHOE COVER	Sep 12, 1989	Substantially Equivalent	American Threshold Industries, Inc.
K893702	TECNOL GAITERS PRODUCT NUMBER 47725-010	Jun 23, 1989	Substantially Equivalent	Tecnol New Jersey Wound Care, Inc.
K883657	SKID RESISTANT, LONG LASTING SHOE COVERS	Sep 15, 1988	Substantially Equivalent	James River Corp.
K882280	COVER, SHOE OPERATING ROOM	Jun 23, 1988	Substantially Equivalent	A Plus International, Inc.
K882128	TECNOL TIGER PAWS PRODUCT NUMBER 47705-010	Jun 15, 1988	Substantially Equivalent	Tecnol New Jersey Wound Care, Inc.
K880093	CARETEX SKID RESISTANT SHOE COVERS	Jan 29, 1988	Substantially Equivalent	James River Corp.
K874064	SHOE COVERS	Nov 04, 1987	Substantially Equivalent	Interpro Intl., Inc.
K872797	NON-SKID SHOE COVERS	Aug 04, 1987	Substantially Equivalent	Abco Dealers, Inc.
K865023	COVER, SHOE OPERATING ROOM	Jan 12, 1987	Substantially Equivalent	Ulti-Med Intl., Inc.
K864550	CARETEX SHOE COVERS	Dec 24, 1986	Substantially Equivalent	James River Corp.
K864026	NONCONDUCTIVE SHOE COVER	Oct 30, 1986	Substantially Equivalent	Kimberly-Clark Corp.
K862726	DISPOSABLE SHOE COVERS AND NURSES CAPS	Aug 01, 1986	Substantially Equivalent	Abco Dealers, Inc.
K861528	TECNOL PERSONAL SHOE COVER	May 12, 1986	Substantially Equivalent	Technol, Inc.
K851554	OVERSHOES (SURCHAUSSURES	Apr 30, 1985	Substantially Equivalent	Roseburg SA
K844705	SHOE COVERS	Jan 10, 1985	Substantially Equivalent	Medicon, Inc.
K843475	PHARMA-PLAST SINGLE USE OVERSHOES	Oct 31, 1984	Substantially Equivalent	Zimmar Consulting , Ltd.
K830821	MICRO-MITT	Apr 27, 1983	Substantially Equivalent	CooperVision, Inc.
K801617	CONDUCTIVE SHOE COVERS	Aug 04, 1980	Substantially Equivalent	Procter & Gamble Mfg. Co.
K801616	NON-CONDUCTIVE SHOE COVERS	Aug 04, 1980	Substantially Equivalent	Procter & Gamble Mfg. Co.
K800809	FLARE DIS. CONDUCTIVE&NON. SHOE COVERS	May 20, 1980	Substantially Equivalent	Flare Products, Inc.
K800528	SHIELD PERFECT FIT; DURA-FIT, DISPOS.	Apr 16, 1980	Substantially Equivalent	American Convertors Div., American Pharmaseal
K780590	SHOE COVERS	May 09, 1978	Substantially Equivalent	Abco Dealers, Inc.
K761072	P.S.M. JUSTA COVER	Dec 02, 1976	Substantially Equivalent	The Owenby Co.
K760779	BARNER SHOE COVERS & COVERBOOTS	Nov 02, 1976	Substantially Equivalent	Surgikos, Inc.