Drape, Surgical, Antimicrobial
FDA product code KKX · Class II (moderate risk) · 21 CFR 878.4370 · General, Plastic Surgery
Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.
450510(k) clearances
0PMA approvals
76recalls
Manufacturers
- Surgikos, Inc. 30
- Procter & Gamble Mfg. Co. 14
- Customed, Inc 11
- DeRoyal Industries Inc 11
- Allegiance Healthcare Corp. 9
- Trinity Laboratories, Inc. 8
- Kimberly-Clark Corp. 8
- Medline Industries, LP 6
- Graham Medical Products 6
- Baxter Healthcare Corp 5
- The Buckeye Cellulose Corp. 5
- Standard Textile Co., Inc. 5
- International Medsurg Connection, Inc. 5
- Advance Medical Designs, Inc. 5
- American Convertors Div., American Pharmaseal 5
- Custom Medical Products, Ltd. 4
- Avery Intl. 4
- 3M Company 4
- 3M Healthcare 4
- Anago, Inc. 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230645 | BeneHold Surgical Incise Drape with CHG antimicrobial IIKKX · Traditional | Avery Dennison Medical , Ltd. | 10/25/2023SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 3M Company | 05/18/2023SE |
| K202208 | BeneHold Surgical Incise Drape with CHG antimicrobialKKX · Traditional | Avery Dennison Belgie Bvba | 07/30/2021SE |
| K200238 | ControlRad Sterile CoverKKX · Traditional | Controlrad, Inc. | 04/26/2020SE |
| K163556 | MediClear PreOpKKX · Traditional | Covalontechnologies, Inc. | 09/14/2017SE |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXXKKX · Traditional | Foshan Nanhai Plus Medical Co, Ltd. | 06/24/2015SE |
| K141324 | Hongyu Disposable Surgical DrapesKKX · Traditional | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 04/14/2015SE |
| K140195 | Surgical DrapeKKX · Traditional | Griffith-Lucas, LLC | 09/10/2014SE |
| K140330 | 3M Steri-Drape Fabric Surgical DrapesKKX · Traditional | 3M Healthcare | 08/18/2014SE |
| K141438 | Whitney Medical Solutions EshieldKKX · Traditional | Whitney Medical Solutions | 08/14/2014SE |
| K140250 | 3M Steri-Drape CHG Antimicrobial Incise DrapeKKX · Traditional | 3M Healthcare | 07/25/2014SE |
| K140064 | Surgisleeve Wound ProtectorKKX · Traditional | Covidien | 03/12/2014SE |
| K131571 | Avd Right Radial DrapeKKX · Traditional | Advanced Vascular Dynamics | 01/31/2014SE |
| K130404 | Tiburon Surgical DrapeKKX · Traditional | Cardinal Health200, LLC | 07/05/2013SE |
| K121436 | Das Medical Equipment DrapesKKX · Traditional | Das Medical, LLC | 06/06/2013SE |
| K121919 | Surgical Drape with Aami Liquid Barrier Level IVKKX · Traditional | Exact Medical Manufacturing, Inc. | 02/14/2013SE |
| K122000 | HM Surgical Drapes HM Surgical Equipment CoverKKX · Traditional | Changzhou Holymed Products Co., Ltd. | 12/12/2012SE |
| K112378 | Cobes Surgical DrapeKKX · Traditional | Cobes Industries Co., Ltd. | 05/08/2012SE |
| K111458 | Gri Sterile and Non-Sterile Surgical Drapes and Surgical Equipment CoversKKX · Traditional | Gri Medical & Electronic Technology Co., Ltd. | 12/01/2011SE |
| K112136 | Top Drape Sterile, Top Drape-Non Sterile, Bottom Drape- Sterile, Bottom DrapeKKX · Traditional | Kunshan Jiehong Nonwoven Product Co., Ltd. | 09/29/2011SE |
| K102861 | Surgiplus SMS Surgical Drape (Sterile/Non-Sterile), Surgiplus SPP with Pe Laminated…KKX · Traditional | A Plus International, Inc. | 01/13/2011SE |
| K101350 | Radscan Equipment SlickerKKX · Traditional | Radscan Medical Equipment, Inc. | 01/04/2011SE |
| K094016 | Next Generation Infused (R) or Towel (Hemed), Next Generation Infused (R) or Towel (with…KKX · Traditional | Hinson and Hale Medical Technologies, Inc. | 11/19/2010SE |
| K102666 | Kimberly-Clark Surgical Drapes with Aami Liquid Barrier Level 4 ClaimKKX · Abbreviated | Kimberly-Clark Corp. | 11/09/2010SE |
| K100991 | Imc Surgical DrapeKKX · Traditional | International Medsurg Connection | 10/05/2010SE |
| K101598 | Emm Surgical Drape SMS W/Pe Sides Model 13-005 (with Minor Dimensional Variations for…KKX · Traditional | Exact Medical Manufacturing, Inc. | 10/04/2010SE |
| K101689 | Emm Equipment Cover-PolythyleneKKX · Traditional | Exact Medical Manufacturing, Inc. | 09/20/2010SE |
| K101688 | Emm Surgical Drape-Spunlace W/Pe Sides, Model 13-004KKX · Traditional | Exact Medical Manufacturing, Inc. | 09/20/2010SE |
| K093909 | Busse Surgical Drapes IVKKX · Traditional | Busse Hospital Disposables, Inc. | 05/06/2010SE |
| K100208 | Imc Surgical DrapeKKX · Special | International Medsurg Connection | 04/20/2010SE |
| K092212 | Busse Surgical Drapes IIIKKX · Special | Busse Hospital Disposables, Inc. | 10/09/2009SE |
| K091343 | MRI Neuro DrapeKKX · Traditional | Surgivision, Inc. | 09/22/2009SE |
| K083234 | Kimberly-Clark KC100 Surgical Drapes, Model KC 100, Kimberly-Clark KC100 Surgical…KKX · Traditional | Kimberly-Clark Corp. | 03/25/2009SE |
| K083320 | Dukal Surgical Drape; Fenestrated Dukal Surgical DrapeKKX · Traditional | Dukal Corp. | 03/06/2009SE |
| K083424 | Busse Surgical DrapeKKX · Traditional | Busse Hosipital Disposables | 02/26/2009SE |
| K082297 | Busse Surgical DrapeKKX · Traditional | Busse Hospital Disposables, Inc. | 12/09/2008SE |
| K080796 | Sri LP DrapeKKX · Abbreviated | Sri/Surgical Express | 11/17/2008SE |
| K080629 | Promedical Surgical Drapes, Promedical Surgical Mayo Stand Cover, Band BagsKKX · Traditional | Promedical Products Co., Ltd. | 10/20/2008SE |
| K081476 | Surgical Concept Designs Positionor Surgical DrapeKKX · Traditional | Surgical Concept Designs | 08/08/2008SE |
| K080341 | Endodrape(Tm)KKX · Abbreviated | Vortek Surgical, LLC | 07/21/2008SE |
| K071491 | Arrow International, Inc., Surgical DrapesKKX · Traditional | Arrow Intl., Inc. | 10/10/2007SE |
| K070432 | General Surgery DrapesKKX · Traditional | Welmed, Inc. | 09/24/2007SE |
| K070406 | EndodrapeKKX · Traditional | Vortek Surgical, LLC | 07/30/2007SE |
| K062480 | Joykey Surgical Drapes (Sterile)KKX · Traditional | Joykey Industryial , Ltd. | 03/05/2007SE |
| K061422 | Surgical DrapesKKX · Traditional | Austin Medical, Inc. | 09/25/2006SE |
| K061762 | Tiburon Drape, Model 9349N/ Optima Drape, Model 9446NKKX · Special | Cardinal Health, Inc. | 08/01/2006SE |
| K052668 | Or Specific Big Case Back Table CoverKKX · Traditional | Or Specific, Inc. | 07/24/2006SE |
| K060200 | Microtek Medical Warming DrapeKKX · Traditional | Microtek Medical, Inc. | 05/31/2006SE |
| K053495 | Equipment Slush DrapeKKX · Traditional | Advance Medical Designs, Inc. | 03/16/2006SE |
| K052833 | Gore-Tex Non-Sterile Surgical GownsKKX · Abbreviated | Medline Industries, Inc. | 02/15/2006SE |
| K052395 | Sterile Equipment CoversKKX · Traditional | Volcano Corporation | 12/01/2005SE |
| K052169 | Imc Surgical DrapesKKX · Traditional | International Medsurg Connection, Inc. | 11/17/2005SE |
| K043015 | 3L Surgical DrapesKKX · Traditional | 3l Medical Products Co., Ltd. | 08/15/2005SE |
| K051625 | Barrier Surgical DrapesKKX · Special | Molnlycke Health Care, Inc. | 07/14/2005SE |
| K050538 | Imc DrapesKKX · Traditional | Intl. Medsurg Connection, Inc. | 06/07/2005SE |
| K050322 | Microtek Equipment DrapesKKX · Traditional | Microtek Medical, Inc. | 05/17/2005SE |
| K042977 | Lasik Eye DrapeKKX · Traditional | Odyssey Medical, Inc. | 05/10/2005SE |
| K050508 | Hvo, Inc., Disposable Non-Sterile Surgical DrapesKKX · Traditional | Haywood Vocational Opportunities | 04/27/2005SE |
| K042526 | Drape, Surgical, X-Ray Element, Models Non Sterile 6120-00, Sterile 704-B, Non Sterile…KKX · Traditional | Medical Action Industries, Inc. | 04/25/2005SE |
| K032666 | Medline Sterile Disposable Surgical Gowns/DrapesKKX · Traditional | Medline Industries, Inc. | 03/16/2005SE |
| K042893 | Under Buttocks DrapeKKX · Traditional | International Medsurg Connection, Inc. | 03/11/2005SE |
| K041224 | Foothills Surgical DrapesKKX · Traditional | Foothills Industries, Inc. | 02/03/2005SE |
| K042131 | Promedical Surgical DrapesKKX · Traditional | Promedical Products Co., Ltd. | 12/10/2004SE |
| K042137 | Promedical Surgical Mayo Stand Covers, Band Bags, Table Covers and Equipment CoversKKX · Traditional | Promedical Products Co., Ltd. | 10/05/2004SE |
| K041846 | Sabresource DrapeKKX · Traditional | Minrad, Inc. | 08/26/2004SE |
| K041077 | Imalux Oct Probe GuideKKX · Traditional | Imalux Corporation | 06/25/2004SE |
| K031889 | Alexis Wound RetractorKKX · Traditional | Applied Medical Resources Corp. | 09/22/2003SE |
| K031287 | Steri-Drape Surgical DrapesKKX · Traditional | 3M Company | 09/10/2003SE |
| K030908 | Deroyal Surgical Drapes Backtable CoverKKX · Traditional | Deroyal | 08/11/2003SE |
| K031131 | Klinidrape Surgical DrapesKKX · Traditional | Molnlycke Health Care | 06/10/2003SE |
| K031362 | Lac-Mac Limited Innerbloc Various O.R. Drape Based on the Repel, Plus and Gore Surgical…KKX · Traditional | Lac Mac, Ltd. | 05/30/2003SE |
| K030365 | Deroyal Drapes, Sterile, Non-SterileKKX · Traditional | Deroyal Industries, Inc. | 04/29/2003SE |
| K023419 | Trilaminate Drapes/TiburonKKX · Traditional | Allegiance Healthcare Corp. | 02/11/2003SE |
| K023117 | Primagard Surgical GownsKKX · Traditional | Primeline Medical Products, Inc. | 11/08/2002SE |
| K022868 | Primagard Surgical Equipment DrapesKKX · Traditional | Primeline Medical Products, Inc. | 11/08/2002SE |
| K023425 | Drapes with Absorbent ReinforcementKKX · Special | Allegiance Healthcare Corp. | 11/06/2002SE |
| K023432 | Medline Asep Plus Surgical DrapesKKX · Special | Medline Industries, Inc. | 11/04/2002SE |
| K021864 | Primagard Nonsterile Femoral Angiography Drapes (Models PM1-0136, PM1-0119, PM1-0142)KKX · Traditional | Primeline Medical Products, Inc. | 09/23/2002SE |
| K020581 | Coloshield Colonoscopy Drape Model E2000KKX · Traditional | Medical Concepts Development, Inc. | 09/18/2002SE |
| K013958 | Indus Textiles Towel-Sterile and Non-SterileKKX · Traditional | Indus Textiles, Inc. | 08/19/2002SE |
| K020393 | Master & Frank Surgical Drapes (Sterile)KKX · Traditional | Master & Frank Enterprses Co., Ltd. | 05/03/2002SE |
| K020435 | Wound Protector/RetractorKKX · Traditional | Applied Medical Resources Corp. | 04/15/2002SE |
| K012957 | Towel Drape, Models 4409, 4410KKX · Traditional | Dynarex Corp. | 03/06/2002SE |
| K012237 | Mertex-Plus Reusable Surgical DrapeKKX · Traditional | Mercan AB | 10/15/2001SE |
| K012807 | Modification to: Compel Surgical DrapesKKX · Special | Standard Textile Co., Inc. | 10/11/2001SE |
| K012168 | Advance Medical Designs Fluid PouchKKX · Traditional | Advance Medical Designs, Inc. | 09/18/2001SE |
| K011422 | Surgical DrapesKKX · Traditional | Advance Medical Designs, Inc. | 07/10/2001SE |
| K010711 | Ecotract Adjustable Wound Protector/RetractorKKX · Traditional | Advanced Surgical Concepts (Asc) | 05/22/2001SE |
| K000442 | Acti-Gard Antimicrobial Film, Models D6635, D6640, D6648, D6650,D6651, D66XXKKX · Traditional | Medical Concepts Development, Inc. | 04/24/2001SE |
| K010572 | BD Visidrape Ophthalmic Drapes; BD Visiflex Incise DrapeKKX · Special | Becton, Dickinson and Co. | 03/12/2001SE |
| K003670 | Patient Drape, SurgicalKKX · Traditional | Advance Medical Designs, Inc. | 01/26/2001SE |
| K002691 | Com-Med O.R. Towel - Non-Sterile, Blue, Green, WhiteKKX · Traditional | Com-Med International, Inc. | 12/08/2000SE |
| K002702 | Neurotology Drape, Model TBDKKX · Traditional | Gyrus Ent LLC | 10/26/2000SE |
| K002508 | Equipment DrapesKKX · Special | Allegiance Healthcare Corp. | 09/01/2000SE |
| K001858 | Operating Room Towel, Sterile, Colors Blue or WhiteKKX · Traditional | China Nantong Guangda Textile Co., Ltd. | 08/17/2000SE |
| K002419 | Surgical DrapesKKX · Special | Allegiance Healthcare Coporation | 08/15/2000SE |
| K001994 | Eei Slush Pan DrapeKKX · Traditional | Eagle Endoscopic, Inc. | 08/04/2000SE |
| K001667 | Resolve Surgical O.R. TowelsKKX · Traditional | Allegiance Healthcare Corp. | 06/23/2000SE |
| K000906 | Klinidrape Surgical DrapesKKX · Traditional | Molnlycke Health Care, Inc. | 06/23/2000SE |
| K994199 | Various Sterile and Non-Sterile Surgical Drapes, (I.E., Disposables Minor Procedure…KKX · Traditional | Custom Medical Products, Inc. | 06/09/2000SE |
| K000417 | Convertors Equipment DrapesKKX · Traditional | Allegiance Healthcare Corp. | 03/17/2000SE |
| K994211 | Acucam Intraoral Camera Sheaths, Models 023545, 601111, 300407, 601285KKX · Traditional | Dentsply Intl. | 02/04/2000SE |
| K993795 | Convertors Surgical DrapesKKX · Traditional | Allegiance Healthcare Corp. | 01/12/2000SE |
| K991667 | Broadline or TowelsKKX · Traditional | Broadline Medical Industries | 09/27/1999SE |
| K990253 | Securline Operating Room Camera Drape, Model 3600KKX · Traditional | Amba Medical , Ltd. | 09/24/1999SE |
| K991548 | Hal Scope Holder SystemKKX · Traditional | Noved Medical | 06/23/1999SE |
| K981823 | Operating Room TowelsKKX · Traditional | Baldur Systems Corp. | 08/11/1998SE |
| K981818 | Convertors Trilaminate DrapesKKX · Traditional | Allegiance Healthcare Corp. | 07/10/1998SE |
| K980210 | Various Surgical or Patient DrapesKKX · Traditional | Gel-Lite, LLC | 05/15/1998SE |
| K974672 | Msi Surgical DrapesKKX · Traditional | Medical Specialty Innovations, Inc. (Msi) | 03/13/1998SE |
| K980183 | Promax Surgical Drapes and CoversKKX · Traditional | Standard Textile Co., Inc. | 02/26/1998SE |
| K974647 | Fanfold Drape 41 X 57 Product No. 900-633, Recorder No. 0633KKX · Traditional | Customed, Inc. | 01/05/1998SE |
| K973146 | Mentor Super Absorbent DrapeKKX · Traditional | Mentor Ophthalmics, Inc. | 12/04/1997SE |
| K970889 | Ultrasound Transducer DrapeKKX · Traditional | Protek Medical Products, Inc. | 10/20/1997SE |
| K971089 | Opportunity, Inc. Laceration TrayKKX · Traditional | Opportunity, Inc. | 09/16/1997SN |
| K972187 | Bouffant CapKKX · Traditional | American Seal Co. | 09/09/1997SE |
| K970891 | Drape, Surgical-LatexKKX · Traditional | Protek Medical Products, Inc. | 08/22/1997SE |
| K971159 | Surgical DrapesKKX · Traditional | International Medsurg Connection | 06/24/1997SE |
| K970554 | Convertors SMS DrapesKKX · Traditional | Allegiance Healthcare Corp. | 05/27/1997SE |
| K970185 | Sterile Disposable Equipment Magnet CoverKKX · Traditional | Contour Fabricators, Inc. | 04/10/1997SE |
| K970722 | Eye TrayKKX · Traditional | Trinity Laboratories, Inc. | 03/31/1997SE |
| K964142 | Medline Disposable Surgical Drapes and GownsKKX · Traditional | Medline Industries, Inc. | 02/25/1997SE |
| K963675 | The Flat Panel Steirle Drape System(Tm), Video Monitor Sterile DrapeKKX · Traditional | Micro-Medical Devices, Inc. | 01/27/1997SE |
| K964125 | Convertors Drape MaterialKKX · Traditional | Allegiance Healthcare Corp. | 12/23/1996SE |
| K962205 | Sterile and Non-Sterile O.R. Towels, Sterile and Non-Sterile X-Ray Detectable O.R.…KKX · Traditional | Medline Industries, Inc. | 11/26/1996SE |
| K955749 | Tex-Care Sterile StockinetteKKX · Traditional | Flynt Amtex, Inc. | 11/22/1996SE |
| K962003 | Tuat Splatter Control Shield SCS-300KKX · Traditional | Taut, Inc. | 07/18/1996SE |
| K960803 | RX Textiles Sterile StockinetteKKX · Traditional | Rx Textiles, Inc. | 07/12/1996SE |
| K960045 | Envirotex Reusable O.R. Wrapper and Custom Surgical DrapeKKX · Traditional | The Sewing Source, Inc. | 06/05/1996SE |
| K954824 | Protector Retractor & Protector Retractor with DrapeKKX · Traditional | Medical Creative Technologies, Inc. | 04/23/1996SE |
| K960242 | CPR Eye TrayKKX · Traditional | Custom Pack Reliability | 03/12/1996SE |
| K955872 | Volmed Operation DrapeKKX · Traditional | Medal Intl. Sales Co., LLC | 03/12/1996SE |
| K950565 | Deroyal Surgical Instrument DrapeKKX · Traditional | Deroyal Industries, Inc. | 12/13/1995SE |
| K954212 | Contamination Containment DrapeKKX · Traditional | Engineering Controls For Medicine | 10/23/1995SE |
| K952759 | Towel PackKKX · Traditional | Medcare Custom Packaging, Inc. | 09/29/1995SE |
| K953654 | ORS-111KKX · Traditional | O.R. Solutions, Inc. | 09/22/1995SE |
| K933148 | Surgical Drape KitKKX · Traditional | Nobelpharma USA, Inc. | 06/26/1995SE |
| K945755 | Orex(R) O.R Equipment DrapesKKX · Traditional | Thantex Specialties, Inc. | 05/25/1995SE |
| K951214 | Sterile Equipment CoverKKX · Traditional | Gulfstream Medical | 05/16/1995SE |
| K950830 | Sta-Put Non-Magnetic Instrument Drape Catalog #100-187-00 (16X20), 100-186-00 (16X10)…KKX · Traditional | Avail-Southwest Division | 05/03/1995SE |
| K941802 | Or TowelKKX · Traditional | Hermitage Hospital Products, Inc. | 05/03/1995SE |
| K946060 | Remington Medical Disposable Fluoro/Equipment Cover Model RMI8KKX · Traditional | Remington Medical, Inc. | 04/27/1995SE |
| K945656 | The Coupler/Drape(Tm), Video Camera Sterile DrapeKKX · Traditional | Micro-Medical Devices, Inc. | 03/28/1995SE |
| K945486 | Splatter Control ShieldKKX · Traditional | Taut, Inc. | 02/28/1995SE |
| K944863 | Compel SurgicaldrapesKKX · Traditional | Standard Textile Co., Inc. | 02/28/1995SE |
| K944859 | Orex Surgical DrapesKKX · Traditional | Thantex Specialties, Inc. | 02/28/1995SE |
| K946024 | 3M Pediatric Laparotomy Sheet #7938/ #7938NSKKX · Traditional | 3M Healthcare | 02/08/1995SE |
| K946025 | 3M X-Large Sheet #7979/ #7979NSKKX · Traditional | 3M Healthcare | 02/02/1995SE |
| K943393 | Civco Probe Boot/Cord CoverKKX · Traditional | CIVCO Medical Instruments Co., Inc. | 02/02/1995SE |
| K942294 | Asep Plus Surgical DrapesKKX · Traditional | Angelica Uniform | 01/02/1995SE |
| K942228 | Orex O.R. TowelKKX · Traditional | Thantex Specialties, Inc. | 12/20/1994SE |
| K931267 | Convertors Iso Bac Drape MaterialKKX · Traditional | Baxter Healthcare Corp | 11/07/1994SE |
| K934630 | Universal Video/Laser Arm DrapeKKX · Traditional | Hydro-Med Products, Inc. | 10/28/1994SE |
| K923960 | Upper Extermity Drape KitKKX · Traditional | Medikmark, Inc. | 10/07/1994SE |
| K931143 | Amsco Sterile Recoveries Absorbent TowelsKKX · Traditional | Amsco Sterile Recoveries, Inc. | 09/08/1994SE |
| K943122 | Surgical DrapesKKX · Traditional | Mallinckrodt Group, Inc. | 09/07/1994SE |
| K941233 | Global Shoulder O.R. Drape PackKKX · Traditional | Depuy, Inc. | 07/27/1994SE |
| K931146 | Surgical Drapes, ModificationKKX · Traditional | Amsco Sterile Recoveries, Inc. | 06/13/1994SE |
| K940175 | Medsurg Sterile O.R. TowelsKKX · Traditional | Medsurg Industries, Inc. | 05/26/1994SE |
| K941302 | Sterile Impervious Orthopedic StockinetteKKX · Traditional | Cush Industries, Inc. | 05/12/1994SE |
| K931455 | Head SheetKKX · Traditional | Custom Medical Products, Ltd. | 05/05/1994SE |
| K931418 | Surgical DrapeKKX · Traditional | Custom Medical Products, Ltd. | 05/05/1994SE |
| K930815 | Abdominal / Thoracic Patient DrapeKKX · Traditional | Custom Medical Products, Ltd. | 05/05/1994SE |
| K940702 | Convertors Opti-Sorb Drape MaterialKKX · Traditional | Baxter Healthcare Corp | 04/26/1994SE |
| K934445 | Ststorz DP5300 and DP9502 Sterile DrapesKKX · Traditional | Storz Instrument Co. | 04/11/1994SE |
| K924101 | Sterile Convertors SMS Polypropylene Gown & DrapeKKX · Traditional | Baxter Healthcare Corp | 04/11/1994SE |
| K934215 | Contain-OrKKX · Traditional | Dlp, Inc. | 02/09/1994SE |
| K936210 | NpacKKX · Traditional | National Healthcare Linen Service | 02/03/1994SE |
| K932253 | Arthrobot Bi-Fold DrapeKKX · Traditional | Andronic Devices, Ltd. | 02/03/1994SE |
| K931091 | Disposable Ama Sterile Drape Sheet, Cat. No. 5252KKX · Traditional | Alliance Medical, Inc. | 02/03/1994SE |
| K933382 | Imc Cable/Wire CoverKKX · Traditional | Inman Medical Corp. | 01/27/1994SE |
| K932857 | Abdominal Fluid Control Pouch, 203-301-S;ETC.KKX · Traditional | Ansley Medical Products, Inc. | 09/13/1993SE |
| K924335 | DrapesKKX · Traditional | Pfb Inter-Apparel Corp. | 09/07/1993SE |
| K922918 | Barrier Saf-Te Hydrogel DrapeKKX · Traditional | Johnson & Johnson International | 07/06/1993SE |
| K922962 | Various Cameo Med Basic Biopsy Trays, DisposableKKX · Traditional | Cameo, Inc. | 03/23/1993SEKD |
| K922961 | Various Cameo Med Percutaneous Skin Prep Trays,KKX · Traditional | Cameo, Inc. | 03/23/1993SEKD |
| K921657 | Vasectomy DrapeKKX · Traditional | Graham Medical Products | 03/18/1993SE |
| K922059 | Disposable Cystoscopy Splash Drape-Sterile #599KKX · Traditional | Graham Medical Products | 03/03/1993SE |
| K920346 | Various Utility/Surgical Drape, Sterile, DisposablKKX · Traditional | Trinity Laboratories, Inc. | 03/03/1993SE |
| K923811 | Compel Surgical DrapesKKX · Traditional | Standard Textile Co., Inc. | 02/23/1993SE |
| K920808 | OB/GYN DrapeKKX · Traditional | Preferred Medical Products | 02/19/1993SE |
| K923798 | Surgical Gown PackKKX · Traditional | Central Georgia Ancillary Health Systems | 01/27/1993SE |
| K923688 | N-PacKKX · Traditional | National Healthcare Linen Service | 01/27/1993SE |
| K923283 | Sup 5415 Single Use Only Sterile Hospital KitKKX · Traditional | Savoy Medical Supply Co., Inc. | 01/04/1993SESK |
| K920284 | Drape Utility/Surgical Sterile DisposableKKX · Traditional | Trinity Laboratories, Inc. | 10/19/1992SE |
| K921049 | Surgical DrapeKKX · Traditional | Amsco Sterile Recoveries, Inc. | 10/01/1992SE |
| K922828 | Ulcer Wound TrayKKX · Traditional | Ulti-Med Intl., Inc. | 09/28/1992SEKD |
| K920518 | E.R. Suture Tray, Sterile, DisposableKKX · Traditional | Trinity Laboratories, Inc. | 08/17/1992SESK |
| K921394 | Dressing Change Tray, Sterile, DisposableKKX · Traditional | Trinity Laboratories, Inc. | 08/13/1992SEKD |
| K921204 | Deluxe Wound Closure Tray, Sterile, DisposableKKX · Traditional | Trinity Laboratories, Inc. | 08/13/1992SEKD |
| K921203 | Incission & Drainage TrayKKX · Traditional | Trinity Laboratories, Inc. | 08/13/1992SEKD |
| K921350 | Qualtex Tube/Cord OrganizerKKX · Traditional | Deroyal Industries, Inc. | 08/04/1992SE |
| K920045 | Duratech Hospital TowelKKX · Traditional | Techstyles | 07/02/1992SE |
| K915740 | Disposable O.R. Towel, SterileKKX · Traditional | American Threshold Industries, Inc. | 06/22/1992SE |
| K920995 | Barrier Drape Sheet with Symetry FabricKKX · Traditional | Johnson & Johnson Medical, Inc. | 05/31/1992SE |
| K920517 | Minor Laceration Tray W/ Instrument, Sterile, DispKKX · Traditional | Trinity Laboratories, Inc. | 05/11/1992SESK |
| K920341 | Laceration TraysKKX · Traditional | Medikmark, Inc. | 04/23/1992SEKD |
| K920340 | Suture Removal KitKKX · Traditional | Medikmark, Inc. | 04/23/1992SEKD |
| K914761 | Kay-Med Surgical Deape/Drap AccessoriesKKX · Traditional | Kayco Medical, Inc. | 04/06/1992SE |
| K920052 | Health Pak Tray Sox BarriersKKX · Traditional | Healthpak, Inc. | 04/03/1992SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1889-2026 Class II | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E…Unapproved design changes to the products outside of the 510(k) clearance. | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-2124-2026 Class II | Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1409-2026 Class II | Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-2520-2025 Class II | Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06…Surgical drape packs may have open seals, which may compromise the sterility of the product. | O&M Halyard Inc | 07/17/2025Open, Classified |
| Z-1608-2025 Class II | Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK, Model…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… | MEDLINE INDUSTRIES, LP - Northfield | 03/03/2025Open, Classified |
| Z-0983-2025 Class II | Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software…Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. | O&M Halyard, Inc. | 11/26/2024Open, Classified |
| Z-0171-2025 Class II | Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK…It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… | MEDLINE INDUSTRIES, LP - Northfield | 09/04/2024Open, Classified |
| Z-3037-2024 Class II | Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2)…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2328-2023 Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.…Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. | MEDLINE INDUSTRIES, LP - Northfield | 05/15/2023Open, Classified |
| Z-1125-2023 Class II | Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number…The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile… | MEDLINE INDUSTRIES, LP - Northfield | 12/07/2022Open, Classified |
| Z-1086-2023 Class II | Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACKSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | MEDLINE INDUSTRIES, LP - Northfield | 11/17/2022Open, Classified |
| Z-1240-2020 Class II | Arrow Maximal Barrier Drape ASK-00002-1AProduct lidstock contains the incorrect expiration date for the product | Arrow International Inc | 12/20/2019Terminated |
| Z-2010-2018 Class II | Clear Fenestrated Drape with Adhesive; Product Code: CD-00001Product sterility may be compromised due to unsealed packaging. | Arrow International Inc | 04/11/2018Terminated |
| Z-1964-2018 Class II | Maximal Barrier Drape; Product Codes: ASK-00002-1AProduct sterility may be compromised due to unsealed packaging. | Arrow International Inc | 04/11/2018Terminated |
| Z-1963-2018 Class II | Maximal Barrier Drape; Product Codes: ASK-00001-1AProduct sterility may be compromised due to unsealed packaging. | Arrow International Inc | 04/11/2018Terminated |
| Z-2758-2017 Class II | Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal…Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number… | Cardinal Health 200, LLC | 06/27/2017Terminated |
| Z-2757-2017 Class II | Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R…Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number… | Cardinal Health 200, LLC | 06/27/2017Terminated |
| Z-0753-2017 Class III | Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect… | Ecolab Inc | 11/30/2016Terminated |
| Z-0724-2017 Class II | Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code…Drapes within the affected lots may include a manufacturing variation that prevents convenient removal of… | Halyard Health, Inc | 11/09/2016Terminated |
| Z-2744-2016 Class II | Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek…Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile packaging may… | Ecolab Inc | 07/14/2016Terminated |
| Z-1042-2016 Class II | Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile…Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may… | Volcano Corporation | 02/05/2016Terminated |
| Z-1041-2016 Class II | Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment…Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may… | Volcano Corporation | 02/05/2016Terminated |
| Z-1483-2016 Class II | Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-1482-2016 Class II | Catalog Number: 900629 STERILE OR CLOTH TOWEL BLUE Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-1480-2016 Class II | Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-1437-2016 Class II | Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-1430-2016 Class II | Catalog Number: 9001574 LEGGINS 30X42 W/7" CUFF Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-1397-2016 Class II | Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 01/07/2016Terminated |
| Z-2695-2015 Class II | FANFOLD DRAPE 44"X58 60/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-2694-2015 Class II | O.R. TOWELS 25/CS Used by medical staff to perform surgical procedures and patient care…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-2689-2015 Class II | UTILITY DRAPE END PRODUCT 50PK/CS Used by medical staff to perform surgical procedures…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-2670-2015 Class II | BASIC PACK W/OUT GOWN 11/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-2635-2015 Class II | (1) (2) 10/CS CUSTOMED Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-2631-2015 Class II | CENTRAL LINE FULL BODY DRAPE CUSTOMED 28/CS Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-2615-2015 Class II | ENDOVENOUS CUSTOM PACK 5/CS CUSTOMED Used by medical staff to perform surgical…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-2611-2015 Class II | MAYO STAND COVER W/CSR WRAP 30/CS Used by medical staff to perform surgical procedures…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-2596-2015 Class II | UNIVERSAL PACK 3/CS Used by medical staff to perform surgical procedures and patient…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-1393-2015 Class II | da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | Intuitive Surgical, Inc. | 03/16/2015Terminated |
| Z-1392-2015 Class II | da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | Intuitive Surgical, Inc. | 03/16/2015Terminated |
| Z-1391-2015 Class II | da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | Intuitive Surgical, Inc. | 03/16/2015Terminated |
| Z-1390-2015 Class II | da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | Intuitive Surgical, Inc. | 03/16/2015Terminated |
| Z-1389-2015 Class II | da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | Intuitive Surgical, Inc. | 03/16/2015Terminated |
| Z-1388-2015 Class II | da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | Intuitive Surgical, Inc. | 03/16/2015Terminated |
| Z-1387-2015 Class II | da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | Intuitive Surgical, Inc. | 03/16/2015Terminated |
| Z-1386-2015 Class II | da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medical Equipment…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | Intuitive Surgical, Inc. | 03/16/2015Terminated |
| Z-1385-2015 Class II | da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. Microtek Medical…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | Intuitive Surgical, Inc. | 03/16/2015Terminated |
| Z-1384-2015 Class II | da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Microtek Medical…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | Intuitive Surgical, Inc. | 03/16/2015Terminated |
| Z-1383-2015 Class II | da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | Intuitive Surgical, Inc. | 03/16/2015Terminated |
| Z-1382-2015 Class II | da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical Equipment…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | Intuitive Surgical, Inc. | 03/16/2015Terminated |
| Z-1381-2015 Class II | da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | Intuitive Surgical, Inc. | 03/16/2015Terminated |