Product Code: NAB FDA class 1 21 CFR 878.4014

Gauze / Sponge,Nonresorbable For External Use

General, Plastic Surgery

Nonresorbable Gauze/Sponge for External Use is a surgical wound care product made from non-absorbable materials used to cover wounds, provide mechanical wound protection, and absorb exudate during external wound management. These products are not intended to be left inside the body. Classified as FDA Class 1, it is subject to general controls under regulation 878.4014 (General and Plastic Surgery specialty).

View on FDA

510(k)s

FEI Numbers

570

Registration Numbers

570

Unique Applicants

Years Active

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Basic Information

Product Code: NAB
Device Class: FDA class 1
Regulation Number: 878.4014
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 88 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K946015	IVALON EXTERNAL SPONGE	Feb 27, 1995	Substantially Equivalent	Ivalon
K940755	ISOLYER (4X4, 8PLY)	May 02, 1994	Substantially Equivalent	Isolyer Co.
K931610	OMNISORB II, NONWOVEN SPONGE, STERILE AND NON	Jun 24, 1993	Substantially Equivalent	Omni Mfg., Inc.
K925590	MULTI-TRAUMA DRESSING	Apr 08, 1993	Substantially Equivalent	Gam Industries, Inc.
K926072	K-BAND AND K-CREPE	Mar 19, 1993	Substantially Equivalent	Parema , Ltd.
K915591	STERILE GAUZE PADS	Jan 27, 1993	Substantially Equivalent	Eagle Medical, Inc.
K924650	GAUZE SPONGES	Jan 11, 1993	Substantially Equivalent	Dav-Mar Medical Products, Inc.
K923602	ABSORBENT PAD -- MODIFICATION	Dec 07, 1992	Substantially Equivalent	Winfield Laboratories, Inc.
K923115	CLINISORB	Nov 23, 1992	Substantially Equivalent	Hermitage Hospital Products, Inc.
K923378	USP TYPE VII GAUZE SPONGES	Oct 06, 1992	Substantially Equivalent	E.W.A., Ltd.
K923116	COMBINE II WETPROOF PAD	Oct 06, 1992	Substantially Equivalent	Hermitage Hospital Products, Inc.
K923846	BURN DRESSING	Sep 11, 1992	Substantially Equivalent	Medical Action Industries, Inc.
K921227	TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE	May 29, 1992	Substantially Equivalent	Courtaulds Fibers, Inc.
K920282	PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE	May 29, 1992	Substantially Equivalent	Trinity Laboratories, Inc.
K915821	MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES	May 29, 1992	Substantially Equivalent	Kerma Medical Products, Inc.
K920269	EZ GAUZE SPONGE	Apr 22, 1992	Substantially Equivalent	Cal West Trading Co.
K915822	MULTIPLE DRESSING, STERILE NONADDHERENT PADS	Mar 26, 1992	Substantially Equivalent	Kerma Medical Products, Inc.
K914604	MEPITEL NON-ADHERENT SILICONE DRESSING	Mar 25, 1992	Substantially Equivalent	Molnlycke Clinical Products AB
K914937	STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES	Dec 04, 1991	Substantially Equivalent	Kerma Medical Products, Inc.
K914842	GAUZE BANDAGE ROLL	Dec 04, 1991	Substantially Equivalent	Cal West Trading Co.
K914431	ABSORBENT FIBER	Dec 04, 1991	Substantially Equivalent	Ulti-Med Intl., Inc.
K914071	MULTIPLE BURN DRESSING	Dec 04, 1991	Substantially Equivalent	Kerma Medical Products, Inc.
K913779	BANDAGE ROLL, GAUZE	Dec 04, 1991	Substantially Equivalent	Keilei Intl., Inc.
K912952	BANDAGE COMPRESS	Oct 04, 1991	Substantially Equivalent	Cal West Trading Co.
K912950	COMPRESS DRESSING	Oct 04, 1991	Substantially Equivalent	Cal West Trading Co.
K912693	POST OPERATIVE SPONGE	Oct 04, 1991	Substantially Equivalent	Ulti-Med Intl., Inc.
K912692	CONFORMING BANDAGE	Oct 04, 1991	Substantially Equivalent	Ulti-Med Intl., Inc.
K912953	GAUZE COMPRESS	Sep 30, 1991	Substantially Equivalent	Cal West Trading Co.
K912779	GAUZE SPONGE,STERILE 2'S	Sep 30, 1991	Substantially Equivalent	Keilei Intl., Inc.
K912954	STRETCH GAUZE BANDAGE	Sep 10, 1991	Substantially Equivalent	Cal West Trading Co.
K912951	12-PLY GAUZE PAD	Sep 10, 1991	Substantially Equivalent	Cal West Trading Co.
K912949	TRIANGULAR BANDAGE,40	Sep 06, 1991	Substantially Equivalent	Cal West Trading Co.
K910857	ALLDRESS MULTI LAYERED WOUND DRESSING	Apr 12, 1991	Substantially Equivalent	Scott Health Care
K895727	BACKGROUND SUCTION MATT	Oct 24, 1989	Substantially Equivalent	Applied Medical Technologies, Inc.
K891324	HERMITEX SPONGE	Apr 27, 1989	Substantially Equivalent	Hermitage Hospital Products, Inc.
K891101	NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING	Apr 17, 1989	Substantially Equivalent for Some Indications	Smith & Nephew United, Inc.
K890672	ABSORBENT GAUZE ROLL	Apr 07, 1989	Substantially Equivalent	Smith & Nephew United, Inc.
K884335	GAUZE BANDAGE 4 X 6 YDS.	Jan 09, 1989	Substantially Equivalent for Some Indications	North Health Care
K884334	GAUZE BANDAGE 1 X 6 YDS.	Jan 09, 1989	Substantially Equivalent for Some Indications	North Health Care
K884333	GAUZE BANDAGE 2 X 6 YDS.	Jan 09, 1989	Substantially Equivalent for Some Indications	North Health Care
K882115	A-SORB	Oct 03, 1988	Substantially Equivalent	Howard Medical Co.
K870283	3 X 3 SPONGES, NON-STERILE	Feb 24, 1987	Substantially Equivalent	The Medical Group, Inc.
K870282	4 X 4 SPONGES, NON-STERILE	Feb 24, 1987	Substantially Equivalent	The Medical Group, Inc.
K864264	TRICOTEX WOUND CONTACT LAYER DRESSING	Dec 29, 1986	Substantially Equivalent for Some Indications	Smith & Nephew, Inc.
K833735	AN ODOR ABSORBENT BANDAGE	Apr 23, 1984	Substantially Equivalent	American Medical Disposable, Inc.
K833549	PDI SURGICAL SCRUB/BRUSH T150-70	Nov 28, 1983	Substantially Equivalent	Nice-Pak Products, Inc.
K831886	FEMORAL CANAL SPONGE	Sep 12, 1983	Substantially Equivalent	Zimmer, Inc.
K831284	GAUZE BANDAGE	Aug 12, 1983	Substantially Equivalent	Pac-Kit Safety Equipment Co.
K831282	BANDAGE COMPRESS	Aug 12, 1983	Substantially Equivalent	Pac-Kit Safety Equipment Co.
K831281	GAUZE COMPRESS	Aug 12, 1983	Substantially Equivalent	Pac-Kit Safety Equipment Co.
K830473	NOVA GAUZE	Apr 15, 1983	Substantially Equivalent	American Threshold Industries, Inc.
K823879	COVER-ROLL STRETCH	Mar 09, 1983	Substantially Equivalent	Beiersdorf, Inc.
K830166	MOLNLYCKE ETE STERILE NON-ADHERENT DRESS	Feb 09, 1983	Substantially Equivalent	Lada Intl., Inc.
K822987	DRESSING SPONGE	Nov 05, 1982	Substantially Equivalent	Hermitage Hospital Products, Inc.
K822966	CONVERTORS DISPOSABLE DRESSING SPONGE	Nov 05, 1982	Substantially Equivalent	American Hospital Supply Corp.
K821246	MELOLIN	Aug 06, 1982	Substantially Equivalent	Smith & Nephew, Inc.
K822047	INTERSORB DRY BURN VEST & PANTS	Jul 28, 1982	Substantially Equivalent	Chesebrough-Pond'S U.S.A. Co.
K820470	UNIFLEX	Jun 02, 1982	Substantially Equivalent	Howmedica Corp.
K820464	HOLLISTER ODOR ABSORBING WOUND PAD	Mar 23, 1982	Substantially Equivalent	Hollister, Inc.
K820413	AEGIS NON-ADHERENT DRESSING	Mar 12, 1982	Substantially Equivalent	Professional Medical Products, Inc.
K820198	DERMA-AID	Mar 05, 1982	Substantially Equivalent	Winfield Laboratories, Inc.
K820108	TOPPER SPONGES	Feb 12, 1982	Substantially Equivalent	Stan-Pak Ent.
K820139	SOF-ROL CAST PADDING	Feb 05, 1982	Substantially Equivalent	Stan-Pak Ent.
K820105	COMBINE PAD OR ABD	Feb 05, 1982	Substantially Equivalent	Stan-Pak Ent.
K820056	TELFA STRIPS	Feb 05, 1982	Substantially Equivalent	Stan-Pak Ent.
K820098	ROLLER GAUZE	Feb 04, 1982	Substantially Equivalent	Stan-Pak Ent.
K820097	SHEET WADDING CAST PADDING	Feb 04, 1982	Substantially Equivalent	Stan-Pak Ent.
K820096	VAG PACKING	Feb 04, 1982	Substantially Equivalent	Stan-Pak Ent.
K820095	TONSIL SPONGES	Feb 04, 1982	Substantially Equivalent	Stan-Pak Ent.
K820053	KERLIX FLUFFS	Feb 04, 1982	Substantially Equivalent	Stan-Pak Ent.
K813419	COMFORT CUSHION DRY BURN PAD III	Jan 22, 1982	Substantially Equivalent	American Convertors Div., American Pharmaseal
K813308	DOUBLE SEAL TUBEGUAZE STERILE BANDAGE	Dec 29, 1981	Substantially Equivalent	Scholl, Inc.
K812711	STERILE GAUZE PADS 12PLY	Nov 02, 1981	Substantially Equivalent	Medspec Corp.
K811814	TRIANGULAR BANDAGE	Jul 31, 1981	Substantially Equivalent	Abco Dealers, Inc.
K810318	PARKE-DAVIS NON-WOVEN SPONGE	Feb 26, 1981	Substantially Equivalent	Hospital Products Co.
K803125	BONE-DRI SURGICAL SPONGE	Jan 15, 1981	Substantially Equivalent	Howmedica Corp.
K802225	TENDER-SORB DRAIN SPONGES	Sep 26, 1980	Substantially Equivalent	Kendall Research Center
K801996	GUAZE BANDAGES CAT.#101-169	Sep 16, 1980	Substantially Equivalent	Pollak (Intl.), Ltd.
K791726	HYDROGEL-PREP	Nov 20, 1979	Substantially Equivalent	Spenco Medical Corp.
K791926	HAND TOWEL	Oct 17, 1979	Substantially Equivalent	Procter & Gamble Mfg. Co.
K791166	DEXIDE DISPOSABLE PREP SPONGE	Jul 10, 1979	Substantially Equivalent	Dexide, Inc.
K780795	GAUZE SPONGES	Jun 06, 1978	Substantially Equivalent	Abco Dealers, Inc.
K780764	NON-STERILE FOLDED GAUZE	Jun 06, 1978	Substantially Equivalent	The Owenby Co.
K780549	NON-STICK PADS	Apr 19, 1978	Substantially Equivalent	National Patent Development Corp.
K780394	GAUZE FLUFF	Apr 10, 1978	Substantially Equivalent	The Torrent Corp.
K780408	MICRONET LIGHT DRESSING SPONGE	Mar 22, 1978	Substantially Equivalent	Kendall Research Center
K770410	BANDAGE COMPRESS 2, 3, 4	Jun 09, 1977	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K760094	SPONGE, CURITY WASHED GAUZE	Jul 16, 1976	Substantially Equivalent	Kendall Research Center