Product Code: GEC FDA class 1 21 CFR 878.4800

Brush, Scrub, Operating-Room

General, Plastic Surgery

The Brush, Scrub, Operating-Room (product code GEC) is a scrub brush used in the operating room, typically by surgical personnel for preoperative hand and forearm scrubbing to reduce microbial contamination and maintain aseptic technique before surgical procedures. It is classified as FDA Class 1, posing minimal risk, subject only to general controls and not requiring premarket notification. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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510(k)s

FEI Numbers

126

Registration Numbers

126

Unique Applicants

Years Active

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Basic Information

Product Code: GEC
Device Class: FDA class 1
Regulation Number: 878.4800
Medical Specialty: General, Plastic Surgery
Review Panel: SU
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 37 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K971473	IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK	Jul 07, 1997	Substantially Equivalent	M-Pact Worldwide Management Corp.
K960621	EXPANDACELL INSTRUMENT WIPE	Apr 01, 1996	Substantially Equivalent	Shippert Medical Technologies Corp.
K900691	BIODYNE INSTRUMENT WIPES	Mar 08, 1990	Substantially Equivalent	Bio-Dyne, Inc.
K896085	SURGI-BRUSH	Nov 08, 1989	Substantially Equivalent	Sparta Surgical Corp.
K875033	STERILE SCRUBBY SCRUB BRUSH	Feb 19, 1988	Unknown	Medsurg Industries, Inc.
K875129	STERI-CLENS	Feb 18, 1988	Substantially Equivalent	Absorbent Cotton Co., Inc.
K872823	DELTA SCRUB	Jan 07, 1988	Substantially Equivalent	Pacific Biosystems, Inc.
K874653	STERILE SURGICAL SCRUB BRUSH	Dec 30, 1987	Substantially Equivalent	Surgikos, Inc.
K874741	STERI-CLENS(TM) SURGICAL SCRUB SPONGE	Dec 10, 1987	Substantially Equivalent	Absorbent Cotton Co., Inc.
K870258	BIOSCRUB SURGICAL SCRUB BRUSH	Feb 24, 1987	Substantially Equivalent	K. W. Griffen Co.
K854232	PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES	Dec 10, 1985	Substantially Equivalent for Some Indications	American Pharmaseal Div. Ahsc
K844411	SCRUB MATE DRY STERILE SCRUB BRUSH	Dec 17, 1984	Substantially Equivalent	American Sterilizer Co.
K843636	FOAM CARE ONE STEP PREP	Nov 16, 1984	Substantially Equivalent	Ballard Medical Products
K831488	DAVRON PROF. SCRUB BRUSH-DRY/STERILE	Jun 08, 1983	Substantially Equivalent	Minnetonka, Inc.
K831226	MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450	May 16, 1983	Substantially Equivalent	Ballard Medical Products
K830394	PROVIDONE-IODINE PREP-PADS & TOWELETTES	Apr 06, 1983	Substantially Equivalent	H & P Industries, Inc.
K830393	PROVIDONE-IODINE SWABSTICKS	Apr 06, 1983	Substantially Equivalent	H & P Industries, Inc.
K823173	ARRIRM SCRUB BRUSH/SPONGE	Nov 22, 1982	Substantially Equivalent	The Buckeye Cellulose Corp.
K823061	BRUSH, SCRUB, OPERATING ROOM	Nov 05, 1982	Substantially Equivalent	Seamless Hospital Products Co.
K822865	SURGI-SCRUB V	Oct 18, 1982	Substantially Equivalent	Acme United Corp.
K821497	DISPOSABLE SURGICAL SCRUB BRUSHES	Jul 14, 1982	Substantially Equivalent	Medical Systems Research
K820086	CURITY SURGICAL SCRUB BRUSH SPONGE	Jan 28, 1982	Substantially Equivalent	The Kendal Co.
K810655	DISPOSABLE SCRUB BRUSH	May 05, 1981	Substantially Equivalent	Dexide, Inc.
K810337	PDI SURGICAL SCRUB SPONGE-BRUSH-T15070	Feb 26, 1981	Substantially Equivalent	Nice-Pak Products, Inc.
K803116	HEAVY DRAINAGE PACK	Jan 28, 1981	Substantially Equivalent	American Medical Disposable, Inc.
K800058	ANAGO ELECTRO SURGICAL TIP CLEANER	Jan 28, 1980	Substantially Equivalent	Anago, Inc.
K792272	DEXIDE DIS. SUR. SCRUB SPONGE W/PARACHLO	Dec 27, 1979	Substantially Equivalent	Dexide, Inc.
K792273	DEXIDE DIS. PREP SPONGE W/IDEX PATIENT P	Dec 10, 1979	Substantially Equivalent	Dexide, Inc.
K792271	DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE	Dec 10, 1979	Substantially Equivalent	Dexide, Inc.
K792242	SURGI-PREP PAINT STICK #1 WET PACK	Dec 10, 1979	Substantially Equivalent	Gard Research Corp.
K791952	DEXIDE DISPOSABLE SURGICAL SCRUB BRUSH	Oct 17, 1979	Substantially Equivalent	Dexide, Inc.
K791951	DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE	Oct 17, 1979	Substantially Equivalent	Dexide, Inc.
K791950	DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE	Oct 17, 1979	Substantially Equivalent	Dexide, Inc.
K791949	DEXIDE DISPOSABLE SURGICAL SCRUB BRUSH	Oct 17, 1979	Substantially Equivalent	Dexide, Inc.
K791736	MEROCEL INSTRUMENT WIPE	Sep 19, 1979	Substantially Equivalent	Xomed, Inc.
K782173	SURGERY BRUSH	Jan 10, 1979	Substantially Equivalent	Dexide, Inc.
K782172	BRUSH/SPONGE, DISPOSABLE	Jan 10, 1979	Substantially Equivalent	Dexide, Inc.