Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4014](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4014) → NAB — Gauze / Sponge,Nonresorbable For External Use # NAB · Gauze / Sponge,Nonresorbable For External Use _General, Plastic Surgery · 21 CFR 878.4014 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB ## Overview - **Product Code:** NAB - **Device Name:** Gauze / Sponge,Nonresorbable For External Use - **Regulation:** [21 CFR 878.4014](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4014) - **Device Class:** 1 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) ## Identification A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9. ## Recent Cleared Devices (20 of 88) Showing 20 most recent of 88 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K946015](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K946015.md) | IVALON EXTERNAL SPONGE | Ivalon | Feb 27, 1995 | SESE | | [K940755](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K940755.md) | ISOLYER (4X4, 8PLY) | Isolyer Co. | May 2, 1994 | SESE | | [K931610](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K931610.md) | OMNISORB II, NONWOVEN SPONGE, STERILE AND NON | Omni Mfg., Inc. | Jun 24, 1993 | SESE | | [K925590](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K925590.md) | MULTI-TRAUMA DRESSING | Gam Industries, Inc. | Apr 8, 1993 | SESE | | [K926072](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K926072.md) | K-BAND AND K-CREPE | Parema , Ltd. | Mar 19, 1993 | SESE | | [K915591](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K915591.md) | STERILE GAUZE PADS | Eagle Medical, Inc. | Jan 27, 1993 | SESE | | [K924650](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K924650.md) | GAUZE SPONGES | Dav-Mar Medical Products, Inc. | Jan 11, 1993 | SESE | | [K923602](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K923602.md) | ABSORBENT PAD -- MODIFICATION | Winfield Laboratories, Inc. | Dec 7, 1992 | SESE | | [K923115](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K923115.md) | CLINISORB | Hermitage Hospital Products, Inc. | Nov 23, 1992 | SESE | | [K923378](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K923378.md) | USP TYPE VII GAUZE SPONGES | E.W.A., Ltd. | Oct 6, 1992 | SESE | | [K923116](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K923116.md) | COMBINE II WETPROOF PAD | Hermitage Hospital Products, Inc. | Oct 6, 1992 | SESE | | [K923846](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K923846.md) | BURN DRESSING | Medical Action Industries, Inc. | Sep 11, 1992 | SESE | | [K921227](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K921227.md) | TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE | Courtaulds Fibers, Inc. | May 29, 1992 | SESE | | [K920282](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K920282.md) | PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE | Trinity Laboratories, Inc. | May 29, 1992 | SESE | | [K915821](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K915821.md) | MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES | Kerma Medical Products, Inc. | May 29, 1992 | SESE | | [K920269](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K920269.md) | EZ GAUZE SPONGE | Cal West Trading Co. | Apr 22, 1992 | SESE | | [K915822](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K915822.md) | MULTIPLE DRESSING, STERILE NONADDHERENT PADS | Kerma Medical Products, Inc. | Mar 26, 1992 | SESE | | [K914604](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K914604.md) | MEPITEL NON-ADHERENT SILICONE DRESSING | Molnlycke Clinical Products AB | Mar 25, 1992 | SESE | | [K914937](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K914937.md) | STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES | Kerma Medical Products, Inc. | Dec 4, 1991 | SESE | | [K914842](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB/K914842.md) | GAUZE BANDAGE ROLL | Cal West Trading Co. | Dec 4, 1991 | SESE | ## Top Applicants - Stan-Pak Ent. — 9 clearances - Cal West Trading Co. — 8 clearances - Hermitage Hospital Products, Inc. — 4 clearances - Kerma Medical Products, Inc. — 4 clearances - Kendall Research Center — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com