Dressing, Wound, Occlusive
FDA product code NAD · Class I (low risk) · 21 CFR 878.4020 · General, Plastic Surgery
108510(k) clearances
0PMA approvals
16recalls
Manufacturers
- Smith & Nephew, Inc. 5
- Chesebrough-Pond'S U.S.A. Co. 5
- Convatec, A Division of E.R. Squibb & Sons 4
- Fraass Survival Systems, Inc. 4
- The Bfgoodrich Co. 4
- Dermatec, Inc. 4
- Acme United Corp. 3
- Smith & Nephew United, Inc. 3
- Laivan Corp. 3
- Marion Laboratories, Inc. 2
- 3M Company 2
- Derma-Lock Medical Corp. 2
- Boston Medical Products, Inc. 2
- Absorbent Cotton Co., Inc. 2
- Warner-Lambert Co. 1
- Carapac Systems, Inc. 1
- Action Medical Systems, Inc. 1
- Hollister, Inc. 1
- Pollak (Intl.), Ltd. 1
- Zhejiang Longterm Medical Technology Co., Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254246 | LT Antibacterial Foam with Silver DressingNAD · Traditional | Zhejiang Longterm Medical Technology Co., Ltd. | 09/10/2026SE |
| K102403 | Sam Chest Seal with Vavle; Sam Chest SealNAD · Traditional | Sam Medical Products | 03/03/2011SE |
| K091133 | Aplion Topical Care SystemNAD · Traditional | Aplion Medical,Llc | 05/20/2009SE |
| K072560 | Envela (Hydrohesive Occlusive Dressing)NAD · Traditional | Teikoku Pharma USA, Inc. | 06/17/2008SE |
| K080524 | Centurion Sorbaview OTCNAD · Traditional | Tri-State Hospital Supply Corp. | 04/23/2008SE |
| K060046 | DermastreamNAD · Traditional | Enzysurge , Ltd. | 02/27/2006SE |
| K043063 | Oxyband Wound DressingNAD · Traditional | Oxyband Technologies, Inc. | 03/24/2005SE |
| K020781 | Wet ChamberNAD · Traditional | Kinetic Concepts, Inc. | 05/06/2002SE |
| K990530 | Kerlix MD Antimicrobial Gauze DressingNAD · Traditional | The Kendall Company, L.P. | 01/31/2000SE |
| K990861 | Wound Dressing/Abd Pad, Model #10810NAD · Traditional | Hospital Specialty Co. | 04/12/1999SE |
| K964534 | Otosilk Otological Graft DressingNAD · Traditional | Boston Medical Products, Inc. | 04/09/1997SE |
| K960815 | Dupad, Dupad W/Abdom. Pad, Dumex Abdom. Pad, Combo Dressing Roll/Combine Dressing RollNAD · Traditional | Dumex Medical Surgical Products, Ltd. | 04/29/1996SE |
| K955863 | Alldress Multi Layered Wound DressingNAD · Traditional | Molnlycke/Scott Health Care | 03/13/1996SN |
| K952203 | OtosilkNAD · Traditional | Boston Medical Products, Inc. | 07/31/1995SE |
| K930697 | Medline Sterile Gauze SpongesNAD · Traditional | Medline Industries, Inc. | 06/24/1993SE |
| K912022 | Frastec Drynet, Bridal Veil, Various SizesNAD · Traditional | Fraass Survival Systems, Inc. | 08/02/1991SE |
| K905519 | Montrose Dressing ApplicatorsNAD · Traditional | Olemunda Pty , Ltd. | 03/06/1991SE |
| K901853 | Modified Labeling for Bioclusive* Trans Film DressNAD · Traditional | Johnson & Johnson Medical, Inc. | 01/28/1991SE |
| K901378 | Tensoplus LiteNAD · Traditional | Smith & Nephew United, Inc. | 06/12/1990SE |
| K897156 | Hydrasorb(Tm)NAD · Traditional | Avitar, Inc. | 02/21/1990SE |
| K895654 | Sorbex(Tm) Soft SpongeNAD · Traditional | Fountain Pharmaceuticals, Inc. | 02/20/1990SN |
| K895817 | Hermal Wound Care KitNAD · Traditional | Stiefel Research Institute, Inc. | 01/19/1990SE |
| K895845 | 2018 Arterial/Venous Pressure DressingNAD · Traditional | Advance Medical Designs, Inc. | 11/01/1989SE |
| K894254 | Hypafix Dressing Retention SheetNAD · Traditional | Smith & Nephew United, Inc. | 08/31/1989SE |
| K892837 | Steril-Derm Transparent Wound DressingNAD · Traditional | Biointerface Technologies, Inc. | 08/01/1989SE |
| K891998 | Bandage, Muslin, Compressed, Camouflaged, 37X37X52NAD · Traditional | Elwyn Industries | 06/05/1989SE |
| K891459 | Sterile Burnnet Pre-Cut (Various Sizes)NAD · Traditional | Western Medical, Ltd. | 05/26/1989SE |
| K882558 | Areola/Nipple DressingNAD · Traditional | Cooper Surgical/Aesthete | 05/24/1989SE |
| K890603 | Beam Tech Wound Dressing*NAD · Traditional | Beam Tech , Ltd. | 05/23/1989SE |
| K892527 | Duoderm* Transparent Hydrocolloid Dressing-ModifyNAD · Traditional | Convatec, A Division of E.R. Squibb & Sons | 05/11/1989SE |
| K891696 | Duoderm* Extra Thin Flexible Hydrocolloid DressingNAD · Traditional | Convatec, A Division of E.R. Squibb & Sons | 05/04/1989SE |
| K884791 | Perme-Aid Transparent Dressing, #11XXNAD · Traditional | Nitto Denko Technical Corp. | 05/04/1989SE |
| K890354 | Tegapore Wound Contact Material, Product #563XNAD · Traditional | 3M Company | 04/27/1989SN |
| K890940 | Modified Labeling for Polyderm Wbc(Tm)NAD · Traditional | Laivan Corp. | 04/17/1989SE |
| K885325 | Frastec Conformant Dressing, Various SizesNAD · Traditional | Frastec Wound Care Products, Inc. | 04/17/1989SN |
| K883391 | Polymer Adhesive BandageNAD · Traditional | Marion Laboratories, Inc. | 03/23/1989SN |
| K890748 | Allevyn Tracheostomy DressingNAD · Traditional | Smith & Nephew United, Inc. | 03/08/1989SN |
| K883849 | Replicare (Additional Claims)NAD · Traditional | United Medical | 02/08/1989SN |
| K884440 | Tecnol Variable Tension BandageNAD · Traditional | Tecnol New Jersey Wound Care, Inc. | 01/17/1989SN |
| K881426 | Pan-Pra Aid Self-Adhe. Collo. Coated BandageNAD · Traditional | Laboratoire Pan-Pra | 11/10/1988SN |
| K881936 | Oper-Film-Adhesive MembraneNAD · Traditional | Iberhospitex, S.A. | 08/31/1988SN |
| K881731 | Ad-Heal(Tm) Wound DressingNAD · Traditional | Nepera, Inc. | 08/31/1988SN |
| K882696 | Dermicel, Montgomery StrapNAD · Traditional | Bioseal | 08/26/1988SE |
| K881988 | 3M Wound Contact Material, Product #563XNAD · Traditional | 3M Company | 06/27/1988SE |
| K880153 | Polyderm A+B(Tm)NAD · Traditional | Laivan Corp. | 04/13/1988SN |
| K875253 | Bfgoodrich Biothane Non-Adherent DressingNAD · Traditional | The Bfgoodrich Co. | 04/13/1988SN |
| K881050 | Duoderm(R) CGFNAD · Traditional | Convatec, A Division of E.R. Squibb & Sons | 04/01/1988SN |
| K880206 | Polyderm WBC (TM), Waterproof Breathable CoverNAD · Traditional | Laivan Corp. | 03/11/1988SN |
| K874554 | Enviclusive (TM)NAD · Traditional | Marion Laboratories, Inc. | 03/11/1988SE |
| K872573 | Pharmaclusive (TM)NAD · Traditional | Pharmacia, Inc. | 02/29/1988SE |
| K874480 | Modified Manufacturing Process for Omiderm(Tm)NAD · Traditional | Omikron Scientific, Ltd. | 02/22/1988SN |
| K874478 | DynafilmNAD · Traditional | Ferris Mfg. Corp. | 01/14/1988SN |
| K874470 | Mwi 400 Wound DressingNAD · Traditional | Med-West, Inc. | 12/18/1987SN |
| K874161 | Modified Use of Triangle Bandage SterileNAD · Traditional | K. W. Griffen Co. | 12/04/1987SE |
| K874291 | Epi-Lock T.M. PrimadermNAD · Traditional | Derma-Lock Medical Corp. | 11/10/1987SN |
| K873277 | Mitraflex(Tm) Wound DressingNAD · Traditional | Matrix Medica, Inc. | 09/17/1987SN |
| K872988 | Transigen Exudate Controlled Wound DressingNAD · Traditional | Smith & Nephew, Inc. | 09/16/1987SN |
| K872875 | Stretch Gauze BandagesNAD · Traditional | Abco Dealers, Inc. | 09/04/1987SE |
| K872982 | Johnson & Johnson Absorbent Occlusive DressingNAD · Traditional | Johnson & Johnson Professionals, Inc. | 08/14/1987SN |
| K872069 | Kontour Ultra Soft Sponge #SS144.50NAD · Traditional | Winfield Laboratories, Inc. | 07/14/1987SN |
| K872101 | Biofilm Trans. Pouch Ulcer & Wound DressingNAD · Traditional | The Bfgoodrich Co. | 06/30/1987SN |
| K872100 | Biofilm Transorbent Ulcer and Wound DressingNAD · Traditional | The Bfgoodrich Co. | 06/30/1987SN |
| K872099 | Biofilm Trans. Island, Island Ulcer & Wound Dress.NAD · Traditional | The Bfgoodrich Co. | 06/30/1987SN |
| K871166 | Allevyn Hydrophilic Polyurethane DressingNAD · Traditional | Smith & Nephew, Inc. | 06/16/1987SN |
| K871495 | Bandages Catalog Number: 101 to 220NAD · Traditional | I M, Inc. | 05/08/1987SE |
| K870239 | Dressing, Burn, 24 by 36 InchesNAD · Traditional | Fraass Survival Systems, Inc. | 02/06/1987SE |
| K870185 | Bandage, Gauze (Nonabsor. Gauze for External Use)NAD · Traditional | Fraass Survival Systems, Inc. | 02/06/1987SE |
| K864688 | Arnold-King Pressure DressingNAD · Traditional | Angiosystems, Inc. | 01/12/1987SE |
| K863580 | Dermatec Transparent Film DressingNAD · Traditional | Dermatec, Inc. | 12/31/1986SN |
| K863578 | Dermatec Zone Transparent DressingNAD · Traditional | Dermatec, Inc. | 11/25/1986SN |
| K864011 | Exu-Dry Burn/Trauma Dressing, Various SizesNAD · Traditional | Fraass Survival Systems, Inc. | 11/22/1986SN |
| K863379 | Dermatec Burn PadsNAD · Traditional | Dermatec, Inc. | 09/26/1986SN |
| K862935 | Wound Manager(Tm) - SterileNAD · Traditional | Convatec, A Division of E.R. Squibb & Sons | 08/20/1986SN |
| K861972 | DermistripNAD · Traditional | Kells Medical, Inc. | 06/27/1986SN |
| K860085 | Lyofoam Wound DressingsNAD · Traditional | Acme United Corp. | 06/27/1986SN |
| K854740 | PrimadermNAD · Traditional | Absorbent Cotton Co., Inc. | 03/14/1986SN |
| K854850 | Falkon Stretch-SterileNAD · Traditional | G.B.F. Industries, Inc. | 01/13/1986SE |
| K853334 | Non-Adhera Adhesive Pad 3X4NAD · Traditional | American White Cross, Inc. | 08/21/1985SE |
| K852211 | Opsite Wound DressingNAD · Traditional | Smith & Nephew, Inc. | 07/23/1985SN |
| K851383 | Blisterfilm Transparent DressingNAD · Traditional | Chesebrough-Pond'S U.S.A. Co. | 07/05/1985SN |
| K851382 | Chesebrough-Pond's Sequential Wound DressingNAD · Traditional | Chesebrough-Pond'S U.S.A. Co. | 07/05/1985SN |
| K852091 | Alba Dry Burn PadNAD · Traditional | Alba-Waldensian, Inc. | 06/13/1985SE |
| K850535 | Mitrathane DressingNAD · Traditional | Mitral Medical , Ltd. | 06/05/1985SN |
| K850282 | Hypafix Post Operative DressingNAD · Traditional | Smith & Nephew, Inc. | 05/07/1985SE |
| K850904 | Alba Dry Burn DressingNAD · Traditional | Alba Health Care | 04/17/1985SE |
| K850076 | Wound Dressing Model ZB-6NAD · Traditional | Thermedics, Inc. | 04/15/1985SE |
| K843200 | Site StripNAD · Traditional | E-Med Corp. | 03/12/1985SE |
| K844095 | Wet Dressing Water-SterileNAD · Traditional | Absorbent Cotton Co., Inc. | 11/27/1984SE |
| K843140 | Isolate Adhesive Bandage for Dry WoundNAD · Traditional | Chesebrough-Pond'S U.S.A. Co. | 11/08/1984SE |
| K843139 | Isolate Adhesive Bandage for Moist WoundNAD · Traditional | Chesebrough-Pond'S U.S.A. Co. | 11/08/1984SE |
| K842186 | Acu-Derm Transparent Wound DressingNAD · Traditional | Acme United Corp. | 08/24/1984SE |
| K831703 | CoverupsNAD · Traditional | The Urology Group | 01/03/1984SE |
| K833729 | Elastic Breathable Over-Wrap BandageNAD · Traditional | American Medical Disposable, Inc. | 12/30/1983SE |
| K833638 | Dermatex Sterile Finger BandageNAD · Traditional | Dermatec, Inc. | 12/27/1983SE |
| K831204 | MultipleNAD · Traditional | Derma-Lock Medical Corp. | 11/28/1983SE |
| K831454 | Lastoband Adhesive BandagesNAD · Traditional | Smith & Nephew, Inc. | 10/31/1983SE |
| K831283 | Triangle Bandage SterileNAD · Traditional | Pac-Kit Safety Equipment Co. | 08/12/1983SE |
| K831611 | Uni-ThaneNAD · Traditional | Carapac Systems, Inc. | 06/20/1983SE |
| K830050 | Molnlycke Mepore Sterile Self-AdhesiveNAD · Traditional | Lada Intl., Inc. | 06/02/1983SE |
| K830593 | Ensure DressingNAD · Traditional | Warner-Lambert Co. | 04/06/1983SE |
| K823852 | Chesebrough-Pond's Multilayer ElasticNAD · Traditional | Chesebrough-Pond'S U.S.A. Co. | 03/17/1983SE |
| K830089 | Burn DressingNAD · Traditional | Action Medical Systems, Inc. | 03/08/1983SE |
| K822080 | Adhesive Wound Cover FilmNAD · Traditional | Hollister, Inc. | 10/15/1982SE |
| K802021 | Pediband CAT.#195-197NAD · Traditional | Pollak (Intl.), Ltd. | 09/16/1980SE |
| K801840 | Surgical Bandages/Sunleep DXNAD · Traditional | Martin'S Maine Exchange | 09/09/1980SE |
| K800953 | Fixomull SterileNAD · Traditional | Beiersdorf, Inc. | 05/20/1980SE |
| K791369 | Airstrip Theatre Ward DressingNAD · Traditional | Acme United Corp. | 08/28/1979SE |
| K761093 | BandageNAD · Traditional | Paco Pharmaceutical Services, Inc. | 01/06/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0160-2026 Class II | DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings…Wound dressing may have foreign matter on the product. | ConvaTec, Inc | 08/29/2025Open, Classified |
| Z-1531-2025 Class II | Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number:…There is a potential for the sterility of the device to be compromised. | MEDLINE INDUSTRIES, LP - Northfield | 02/19/2025Open, Classified |
| Z-0789-2022 Class II | SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved… | Sam Medical Products | 01/28/2022Terminated |
| Z-2614-2021 Class II | DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)Primary packaging labeling may be incorrect. | ConvaTec, Inc | 08/20/2021Open, Classified |
| Z-2519-2021 Class II | DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM…There is a potential for open seals which can compromise sterility. | ConvaTec, Inc | 08/09/2021Open, Classified |
| Z-0018-2019 Class II | Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product…Potential for product sterility breach due to a compromised or pinched seal defect | Covidien LLC | 08/01/2018Terminated |
| Z-0017-2019 Class II | Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product…Potential for product sterility breach due to a compromised or pinched seal defect | Covidien LLC | 08/01/2018Terminated |
| Z-0016-2019 Class II | Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716…Potential for product sterility breach due to a compromised or pinched seal defect | Covidien LLC | 08/01/2018Terminated |
| Z-0015-2019 Class II | Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880…Potential for product sterility breach due to a compromised or pinched seal defect | Covidien LLC | 08/01/2018Terminated |
| Z-0014-2019 Class II | Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF…Potential for product sterility breach due to a compromised or pinched seal defect | Covidien LLC | 08/01/2018Terminated |
| Z-0013-2019 Class II | Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332…Potential for product sterility breach due to a compromised or pinched seal defect | Covidien LLC | 08/01/2018Terminated |
| Z-1745-2017 Class II | Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity…Product sterility is compromised due to breach of sterile barrier | Covidien LLC | 03/03/2017Terminated |
| Z-1744-2017 Class II | Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item…Product sterility is compromised due to breach of sterile barrier | Covidien LLC | 03/03/2017Terminated |
| Z-1743-2017 Class II | Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium…Product sterility is compromised due to breach of sterile barrier | Covidien LLC | 03/03/2017Terminated |
| Z-0138-2015 Class III | Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of…Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing… | Coloplast Manufacturing US, LLC | 09/08/2014Terminated |
| Z-1310-2010 | Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile Part…Incorrect expiration date on outer kit label-extended. | Aplicare, Inc. | 03/03/2010Terminated |