Gauze / Sponge,Nonresorbable For External Use
FDA product code NAB · Class I (low risk) · 21 CFR 878.4014 · General, Plastic Surgery
88510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Stan-Pak Ent. 9
- Cal West Trading Co. 8
- Kerma Medical Products, Inc. 4
- Hermitage Hospital Products, Inc. 4
- Pac-Kit Safety Equipment Co. 3
- Ulti-Med Intl., Inc. 3
- North Health Care 3
- Kendall Research Center 3
- Howmedica Corp. 2
- Smith & Nephew, Inc. 2
- Keilei Intl., Inc. 2
- Winfield Laboratories, Inc. 2
- The Medical Group, Inc. 2
- Abco Dealers, Inc. 2
- Smith & Nephew United, Inc. 2
- Ivalon 1
- Medspec Corp. 1
- Hospital Products Co. 1
- Pollak (Intl.), Ltd. 1
- The Owenby Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K946015 | Ivalon External SpongeNAB · Traditional | Ivalon | 02/27/1995SE |
| K940755 | Isolyer (4X4, 8PLY)NAB · Traditional | Isolyer Co. | 05/02/1994SE |
| K931610 | Omnisorb II, Nonwoven Sponge, Sterile and NonNAB · Traditional | Omni Mfg., Inc. | 06/24/1993SE |
| K925590 | Multi-Trauma DressingNAB · Traditional | Gam Industries, Inc. | 04/08/1993SE |
| K926072 | K-Band and K-CrepeNAB · Traditional | Parema , Ltd. | 03/19/1993SE |
| K915591 | Sterile Gauze PadsNAB · Traditional | Eagle Medical, Inc. | 01/27/1993SE |
| K924650 | Gauze SpongesNAB · Traditional | Dav-Mar Medical Products, Inc. | 01/11/1993SE |
| K923602 | Absorbent Pad -- ModificationNAB · Traditional | Winfield Laboratories, Inc. | 12/07/1992SE |
| K923115 | ClinisorbNAB · Traditional | Hermitage Hospital Products, Inc. | 11/23/1992SE |
| K923378 | Usp Type Vii Gauze SpongesNAB · Traditional | E.W.A., Ltd. | 10/06/1992SE |
| K923116 | Combine II Wetproof PadNAB · Traditional | Hermitage Hospital Products, Inc. | 10/06/1992SE |
| K923846 | Burn DressingNAB · Traditional | Medical Action Industries, Inc. | 09/11/1992SE |
| K921227 | Tencel Topical Wound Dressing/Surgical SpongeNAB · Traditional | Courtaulds Fibers, Inc. | 05/29/1992SE |
| K920282 | Pre-Cut Tracheostomy Dressing Sterile, DisposableNAB · Traditional | Trinity Laboratories, Inc. | 05/29/1992SE |
| K915821 | Multiple Sterile Gauze Bandage Rolls, Vari SizesNAB · Traditional | Kerma Medical Products, Inc. | 05/29/1992SE |
| K920269 | Ez Gauze SpongeNAB · Traditional | Cal West Trading Co. | 04/22/1992SE |
| K915822 | Multiple Dressing, Sterile Nonaddherent PadsNAB · Traditional | Kerma Medical Products, Inc. | 03/26/1992SE |
| K914604 | Mepitel Non-Adherent Silicone DressingNAB · Traditional | Molnlycke Clinical Products AB | 03/25/1992SE |
| K914937 | Sterile Bandage, Gauze, Fine Mesh, 3X8 InchesNAB · Traditional | Kerma Medical Products, Inc. | 12/04/1991SE |
| K914842 | Gauze Bandage RollNAB · Traditional | Cal West Trading Co. | 12/04/1991SE |
| K914431 | Absorbent FiberNAB · Traditional | Ulti-Med Intl., Inc. | 12/04/1991SE |
| K914071 | Multiple Burn DressingNAB · Traditional | Kerma Medical Products, Inc. | 12/04/1991SE |
| K913779 | Bandage Roll, GauzeNAB · Traditional | Keilei Intl., Inc. | 12/04/1991SE |
| K912952 | Bandage CompressNAB · Traditional | Cal West Trading Co. | 10/04/1991SE |
| K912950 | Compress DressingNAB · Traditional | Cal West Trading Co. | 10/04/1991SE |
| K912693 | Post Operative SpongeNAB · Traditional | Ulti-Med Intl., Inc. | 10/04/1991SE |
| K912692 | Conforming BandageNAB · Traditional | Ulti-Med Intl., Inc. | 10/04/1991SE |
| K912953 | Gauze CompressNAB · Traditional | Cal West Trading Co. | 09/30/1991SE |
| K912779 | Gauze Sponge,Sterile 2'SNAB · Traditional | Keilei Intl., Inc. | 09/30/1991SE |
| K912954 | Stretch Gauze BandageNAB · Traditional | Cal West Trading Co. | 09/10/1991SE |
| K912951 | 12-PLY Gauze PadNAB · Traditional | Cal West Trading Co. | 09/10/1991SE |
| K912949 | Triangular BANDAGE,40NAB · Traditional | Cal West Trading Co. | 09/06/1991SE |
| K910857 | Alldress Multi Layered Wound DressingNAB · Traditional | Scott Health Care | 04/12/1991SE |
| K895727 | Background Suction MattNAB · Traditional | Applied Medical Technologies, Inc. | 10/24/1989SE |
| K891324 | Hermitex SpongeNAB · Traditional | Hermitage Hospital Products, Inc. | 04/27/1989SE |
| K891101 | Non-Absorbable Gauze, Surgical Sponge & DressingNAB · Traditional | Smith & Nephew United, Inc. | 04/17/1989SN |
| K890672 | Absorbent Gauze RollNAB · Traditional | Smith & Nephew United, Inc. | 04/07/1989SE |
| K884335 | Gauze Bandage 4 X 6 Yds.NAB · Traditional | North Health Care | 01/09/1989SN |
| K884334 | Gauze Bandage 1 X 6 Yds.NAB · Traditional | North Health Care | 01/09/1989SN |
| K884333 | Gauze Bandage 2 X 6 Yds.NAB · Traditional | North Health Care | 01/09/1989SN |
| K882115 | A-SorbNAB · Traditional | Howard Medical Co. | 10/03/1988SE |
| K870283 | 3 X 3 Sponges, Non-SterileNAB · Traditional | The Medical Group, Inc. | 02/24/1987SE |
| K870282 | 4 X 4 Sponges, Non-SterileNAB · Traditional | The Medical Group, Inc. | 02/24/1987SE |
| K864264 | Tricotex Wound Contact Layer DressingNAB · Traditional | Smith & Nephew, Inc. | 12/29/1986SN |
| K833735 | An Odor Absorbent BandageNAB · Traditional | American Medical Disposable, Inc. | 04/23/1984SE |
| K833549 | Pdi Surgical Scrub/Brush T150-70NAB · Traditional | Nice-Pak Products, Inc. | 11/28/1983SE |
| K831886 | Femoral Canal SpongeNAB · Traditional | Zimmer, Inc. | 09/12/1983SE |
| K831284 | Gauze BandageNAB · Traditional | Pac-Kit Safety Equipment Co. | 08/12/1983SE |
| K831282 | Bandage CompressNAB · Traditional | Pac-Kit Safety Equipment Co. | 08/12/1983SE |
| K831281 | Gauze CompressNAB · Traditional | Pac-Kit Safety Equipment Co. | 08/12/1983SE |
| K830473 | Nova GauzeNAB · Traditional | American Threshold Industries, Inc. | 04/15/1983SE |
| K823879 | Cover-Roll StretchNAB · Traditional | Beiersdorf, Inc. | 03/09/1983SE |
| K830166 | Molnlycke Ete Sterile Non-Adherent DressNAB · Traditional | Lada Intl., Inc. | 02/09/1983SE |
| K822987 | Dressing SpongeNAB · Traditional | Hermitage Hospital Products, Inc. | 11/05/1982SE |
| K822966 | Convertors Disposable Dressing SpongeNAB · Traditional | American Hospital Supply Corp. | 11/05/1982SE |
| K821246 | MelolinNAB · Traditional | Smith & Nephew, Inc. | 08/06/1982SE |
| K822047 | Intersorb Dry Burn Vest & PantsNAB · Traditional | Chesebrough-Pond'S U.S.A. Co. | 07/28/1982SE |
| K820470 | UniflexNAB · Traditional | Howmedica Corp. | 06/02/1982SE |
| K820464 | Hollister Odor Absorbing Wound PadNAB · Traditional | Hollister, Inc. | 03/23/1982SE |
| K820413 | Aegis Non-Adherent DressingNAB · Traditional | Professional Medical Products, Inc. | 03/12/1982SE |
| K820198 | Derma-AidNAB · Traditional | Winfield Laboratories, Inc. | 03/05/1982SE |
| K820108 | Topper SpongesNAB · Traditional | Stan-Pak Ent. | 02/12/1982SE |
| K820139 | Sof-Rol Cast PaddingNAB · Traditional | Stan-Pak Ent. | 02/05/1982SE |
| K820105 | Combine Pad or AbdNAB · Traditional | Stan-Pak Ent. | 02/05/1982SE |
| K820056 | Telfa StripsNAB · Traditional | Stan-Pak Ent. | 02/05/1982SE |
| K820098 | Roller GauzeNAB · Traditional | Stan-Pak Ent. | 02/04/1982SE |
| K820097 | Sheet Wadding Cast PaddingNAB · Traditional | Stan-Pak Ent. | 02/04/1982SE |
| K820096 | Vag PackingNAB · Traditional | Stan-Pak Ent. | 02/04/1982SE |
| K820095 | Tonsil SpongesNAB · Traditional | Stan-Pak Ent. | 02/04/1982SE |
| K820053 | Kerlix FluffsNAB · Traditional | Stan-Pak Ent. | 02/04/1982SE |
| K813419 | Comfort Cushion Dry Burn Pad IIINAB · Traditional | American Convertors Div., American Pharmaseal | 01/22/1982SE |
| K813308 | Double Seal Tubeguaze Sterile BandageNAB · Traditional | Scholl, Inc. | 12/29/1981SE |
| K812711 | Sterile Gauze Pads 12PLYNAB · Traditional | Medspec Corp. | 11/02/1981SE |
| K811814 | Triangular BandageNAB · Traditional | Abco Dealers, Inc. | 07/31/1981SE |
| K810318 | Parke-Davis Non-Woven SpongeNAB · Traditional | Hospital Products Co. | 02/26/1981SE |
| K803125 | Bone-Dri Surgical SpongeNAB · Traditional | Howmedica Corp. | 01/15/1981SE |
| K802225 | Tender-Sorb Drain SpongesNAB · Traditional | Kendall Research Center | 09/26/1980SE |
| K801996 | Guaze Bandages CAT.#101-169NAB · Traditional | Pollak (Intl.), Ltd. | 09/16/1980SE |
| K791726 | Hydrogel-PrepNAB · Traditional | Spenco Medical Corp. | 11/20/1979SE |
| K791926 | Hand TowelNAB · Traditional | Procter & Gamble Mfg. Co. | 10/17/1979SE |
| K791166 | Dexide Disposable Prep SpongeNAB · Traditional | Dexide, Inc. | 07/10/1979SE |
| K780795 | Gauze SpongesNAB · Traditional | Abco Dealers, Inc. | 06/06/1978SE |
| K780764 | Non-Sterile Folded GauzeNAB · Traditional | The Owenby Co. | 06/06/1978SE |
| K780549 | Non-Stick PadsNAB · Traditional | National Patent Development Corp. | 04/19/1978SE |
| K780394 | Gauze FluffNAB · Traditional | The Torrent Corp. | 04/10/1978SE |
| K780408 | Micronet Light Dressing SpongeNAB · Traditional | Kendall Research Center | 03/22/1978SE |
| K770410 | Bandage Compress 2, 3, 4NAB · Traditional | Johnson & Johnson Professionals, Inc. | 06/09/1977SE |
| K760094 | Sponge, Curity Washed GauzeNAB · Traditional | Kendall Research Center | 07/16/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0615-2021 Class II | RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec…RevMedX Trauma Dressing is being recalled due to package seal integrity. | Medline Industries Inc | 11/05/2020Terminated |
| Z-0957-2019 Class II | Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code:…Curity All Purpose Sponges were not sterilized and distributed | Cardinal Health 200, LLC | 12/27/2018Terminated |
| Z-0525-2019 Class II | Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached…Potential that gauze pads may not be fully sterilized | Aso, LLC | 10/16/2018Open, Classified |
| Z-2762-2015 Class II | XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded…The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during… | Revmedx Inc | 08/12/2015Terminated |
| Z-1858-2012 Class II | Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case…Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and… | Hartmann USA, Inc | 05/14/2012Terminated |
| Z-1857-2012 Class II | Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total…Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and… | Hartmann USA, Inc | 05/14/2012Terminated |