Gown, Surgical
FDA product code FYA · Class II (moderate risk) · 21 CFR 878.4040 · General, Plastic Surgery
298510(k) clearances
0PMA approvals
120recalls
Manufacturers
- Medline Industries, LP 16
- Standard Textile Co., Inc. 14
- Kimberly-Clark Corp. 12
- The Sewing Source, Inc. 8
- Allegiance Healthcare Corp. 8
- The Buckeye Cellulose Corp. 7
- Baxter Healthcare Corp 6
- Surgikos, Inc. 5
- Foshan Nanhai Plus Medical Co, Ltd. 5
- Stryker Instruments 5
- Procter & Gamble Mfg. Co. 5
- Lac Mac, Ltd. 4
- Stryker Corporation 4
- Cardinal Health200, LLC 4
- Gri Medical & Electrical Technology Co., Ltd. 3
- Molnlycke Health Care, Inc. 3
- Depuy, Inc. 3
- Promedical Products Co., Ltd. 3
- Exact Medical Manufacturing, Inc. 3
- Sri/Surgical Express 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260407 | Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns…FYA · Traditional | Principle & Will Co., Ltd. | 08/26/2026SE |
| K261028 | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)FYA · Traditional | Yadu Medical (Henan) Co., Ltd. | 08/07/2026SE |
| K261949 | NYES Tuff Cuff L3 Disposable GownsFYA · Special | New York Embroidery Studio | 07/10/2026SE |
| K252575 | Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)FYA · Traditional | New York Embroidery Studio (NYES) | 06/04/2026SE |
| K260725 | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)FYA · Traditional | Hindernis DE Mexico, S.A.P.I. DE C.V. | 05/12/2026SE |
| K253243 | Cardinal Health Poly Reinforced Surgical GownFYA · Abbreviated | Cardinal Health 200, LLC | 04/28/2026SE |
| K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…FYA · Traditional | Hubei Xinxin Non-Woven Co., Ltd. | 04/20/2026SE |
| K251860 | Copioumed AAMI 3 Surgical GownFYA · Traditional | Copioumed International, Inc. | 02/26/2026SE |
| K252301 | Henan Yadu Level 4 Surgical Gowns (Reinforced)FYA · Traditional | Yadu Medical (Henan) Co., Ltd. | 02/04/2026SE |
| K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)FYA · Traditional | Yadu Medical (Henan) Co., Ltd. | 12/03/2025SE |
| K243522 | ViVi® Toga PremiumFYA · Traditional | Thi Total Healthcare Innovation GmbH | 05/30/2025SE |
| K242937 | Dream Medi Sterile Surgical Gown (SurgicalGownUL)FYA · Traditional | Dae Myung Chemical Co., Ltd. (Vietnam) | 05/05/2025SE |
| K242844 | Medline Level 4 Surgical Gown with Breathable SleevesFYA · Traditional | Medline Industries, LP | 02/26/2025SE |
| K241272 | Stryker Steri-Shield 8 Surgical Hoods and TogasFYA · Traditional | Stryker Instruments | 10/16/2024SE |
| K241214 | ProPel SG3 Surgical GownFYA · Traditional | Standard Textile Co., Inc. | 09/10/2024SE |
| K233571 | GCI Surgical GownFYA · Traditional | George Courey, Inc. | 08/02/2024SE |
| K233068 | Disposable Surgical GownFYA · Traditional | Nanning Tecbod Biological Technology Co., Ltd. | 03/29/2024SE |
| K233183 | Surgical Gown (40083)FYA · Traditional | Ammex-Weida (Hubei) Health and Safety Products… | 02/01/2024SE |
| K230707 | Skypro, Surgical Gown 6021FYA · Traditional | Skypro Medical Supplies Company | 10/12/2023SE |
| K230610 | Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3…FYA · Traditional | Dongguan Shin YI Healthcare Products Factory | 08/23/2023SE |
| K231510 | Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)FYA · Traditional | Xiantao Zhibo Non-Woven Products Co., Ltd. | 08/22/2023SE |
| K230577 | Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)FYA · Traditional | Medcare Saglik Urunleri Sanayi VE Ticaret Anonim… | 08/16/2023SE |
| K230838 | Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument PocketsFYA · Traditional | Cardinal Health200, LLC | 07/27/2023SE |
| K222999 | Surgical GownFYA · Traditional | Hubei Woozon Healthcare Co., Ltd. | 06/16/2023SE |
| K222456 | High Protection Surgical GownFYA · Traditional | 3A Medical Products Co., Ltd. | 03/12/2023SE |
| K223401 | Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)FYA · Traditional | Xiamen Probtain Medical Techology Co., Ltd. | 03/07/2023SE |
| K221559 | Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3FYA · Traditional | Stringking | 02/23/2023SE |
| K213844 | Surgical GownFYA · Traditional | Bayteks Teknik Tekstil San. VE Tic. A.S. | 02/16/2023SE |
| K220435 | SEJONG Surgical Gown SoftFYA · Traditional | Sejong Healthcare Co., Ltd. | 02/10/2023SE |
| K222403 | Surgical GownFYA · Traditional | Guangzhou Fuzelong Hygiene Material Co., Ltd. | 01/26/2023SE |
| K213893 | Comfort Gown, Safewear GownFYA · Traditional | Xuchang Zhengde Environstar Medical Products… | 12/21/2022SE |
| K212812 | Surgical GownFYA · Traditional | Xianning Marveldas Protective Articles Co., Ltd. | 11/16/2022SE |
| K222480 | Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)FYA · Traditional | Foshan Nanhai Plus Medical Co, Ltd. | 11/14/2022SE |
| K221139 | Bodygard SFS Surgical Gown Level 4FYA · Traditional | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri | 11/10/2022SE |
| K211060 | Disposable Surgical Gown Rk-3011CFYA · Traditional | Xiantao Rhycom Non-Woven Products Co., Ltd. | 10/28/2022SE |
| K221977 | Disposable Surgical Gown (G4003)FYA · Traditional | Xiantao Topmed Nonwoven Protective Products Co.… | 10/20/2022SE |
| K220092 | YADU Surgical GownsFYA · Traditional | Henan Yadu Industrial Co., Ltd. | 10/07/2022SE |
| K221637 | Surgical Gown (Sterile); Surgical Gown (Non-sterile)FYA · Traditional | Allmed Medical (Hubei) Protective Products Co.… | 09/29/2022SE |
| K221717 | Disposable Surgical Gown UM-148FYA · Traditional | Unimax Medical Products Co., Ltd. | 09/20/2022SE |
| K221819 | 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS…FYA · Traditional | Winner Medical Co., Ltd. | 09/19/2022SE |
| K211399 | Sterile Level 3 Surgical GownFYA · Traditional | Barco Tekstil Sanayi VE Ticaret A.S. | 07/22/2022SE |
| K220665 | Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-SterileFYA · Traditional | Excellent Medical Technology Group Co., Ltd. | 06/03/2022SE |
| K220333 | Medline Orbis LVL 3 Surgical GownFYA · Traditional | Medline Industries, LP | 05/18/2022SE |
| K213177 | Plus Medical Cover GownFYA · Traditional | Foshan Nanhai Plus Medical Co, Ltd. | 05/11/2022SE |
| K214108 | Medline Orbis Chemo Surgical GownFYA · Traditional | Medline Industries, LP | 05/06/2022SE |
| K211036 | Plus Medical Chemotherapy GownFYA · Traditional | Foshan Nanhai Plus Medical Co, Ltd. | 05/04/2022SE |
| K214088 | Disposable Surgical GownFYA · Traditional | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 04/12/2022SE |
| K203237 | Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown…FYA · Traditional | Dukal Corporation | 03/18/2022SE |
| K201351 | Maxima Surgical GownFYA · Traditional | Elevate Textiles | 03/11/2022SE |
| K213703 | Surgical GownFYA · Traditional | Wujiang Tutaike Textiles & Finishing Co., Ltd. | 03/04/2022SE |
| K202845 | Bodygard SFS Surgical Gown Level 3FYA · Traditional | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri… | 02/24/2022SE |
| K203548 | EndoArmor + Surgical GownFYA · Traditional | Boston Scientific Corporation | 02/21/2022SE |
| K212718 | Surgical gownsFYA · Traditional | Xiantao Dingcheng Non-Woven Product Co., Ltd. | 01/12/2022SE |
| K212591 | Disposable Surgical GownFYA · Traditional | Suzhou Janee Medical Technology Co., Ltd. | 01/11/2022SE |
| K210355 | Surgical Gown, Model: surgical gown-hp-3FYA · Traditional | Weihai Dishang Medical Technology Co., Ltd. | 12/16/2021SE |
| K212861 | Surgical Gown, Reinforced Surgical GownFYA · Traditional | Wuhan Zonsen Medical Products Co., Ltd. | 12/15/2021SE |
| K212925 | Disposable Surgical GownFYA · Traditional | Henan Robestain Medical Products Co., Ltd. | 12/13/2021SE |
| K212869 | Disposable Surgical Gown, Disposable Reinforced Surgical GownFYA · Traditional | Fugou County Shenxiang Manufacturing Co., Ltd. | 12/13/2021SE |
| K203539 | Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical…FYA · Traditional | Unicoglobal, Inc. | 12/10/2021SE |
| K211765 | Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse GownFYA · Traditional | Cardinal Health, LLC | 11/23/2021SE |
| K211509 | Surgical GownFYA · Traditional | Hubei Wanli Protective Products Co., Ltd. | 10/24/2021SE |
| K211809 | Surgical GownFYA · Traditional | Wuhan Dymex Healthcare Co., Ltd. | 10/18/2021SE |
| K211077 | Surgical GownFYA · Traditional | Wujiang Tutaike Textiles & Finishing Co., Ltd. | 10/07/2021SE |
| K202532 | Disposable Surgical GownsFYA · Traditional | Anhui Medpurest Medical Technology Co.,Ltd | 08/21/2021SE |
| K210510 | Disposable Surgical GownFYA · Traditional | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 08/12/2021SE |
| K210143 | Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)FYA · Traditional | Foshan Nanhai Plus Medical Co, Ltd. | 07/22/2021SE |
| K210688 | AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable…FYA · Abbreviated | O&M Halyard, Inc. | 07/21/2021SE |
| K210215 | Surgical GownsFYA · Traditional | Jiangsu Province Jianerkang Medical Dressing… | 07/07/2021SE |
| K211422 | Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced…FYA · Traditional | Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. | 07/02/2021SE |
| K202447 | Medline Orbis Surgical GownFYA · Traditional | Medline Industries, Inc. | 04/02/2021SE |
| K202844 | Medical Surgical GownsFYA · Traditional | Beijing Biosis Healing Biolog Ical Technology… | 01/06/2021SE |
| K202706 | Surgical Gown (Sterile), Surgical Gown (Non-sterile)FYA · Traditional | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 12/31/2020SE |
| K200977 | Modular TogaFYA · Traditional | Operating Room Innovations, Inc. | 08/05/2020SE |
| K200824 | Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR…FYA · Traditional | Cardinal Health200, LLC | 07/29/2020SE |
| K192560 | Surgical GownFYA · Traditional | Shandong Kangli Medical Equipment Technology… | 05/22/2020SE |
| K192290 | 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB…FYA · Traditional | Xuchang Zhengde Environstar Medical Products… | 04/30/2020SE |
| K193327 | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus…FYA · Traditional | Cardinal Health200, LLC | 03/20/2020SE |
| K200522 | AERO CHROME* Breathable Performance Surgical GownsFYA · Abbreviated | O&M Halyard, Inc. | 03/16/2020SE |
| K192362 | Aero Blue Performance Surgical GownsFYA · Abbreviated | O&M Halyard, Inc. | 12/13/2019SE |
| K192194 | TotalShield II Surgical Helmet SystemFYA · Special | Zimmer Surgical, Inc. | 10/15/2019SE |
| K190950 | Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown…FYA · Traditional | Medline Industries, Inc. | 07/04/2019SE |
| K182172 | Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline…FYA · Traditional | Medline Industries, Inc. | 04/24/2019SE |
| K173847 | Disposable Ultra Reinforced Surgical GownFYA · Traditional | Xiantao Rayxin Medical Products Co., Ltd. | 01/16/2019SE |
| K172987 | Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)FYA · Traditional | Gmax Industries, Inc. | 07/13/2018SE |
| K172954 | Medline Prevention CoolZone GownFYA · Traditional | Medline Industries, Inc. | 06/15/2018SE |
| K172445 | RoyalGuard Surgical Gown, i600, BreathableFYA · Traditional | Gri Medical & Electrical Technology Co., Ltd. | 12/08/2017SE |
| K170762 | Cardinal Health Non-Reinforced Surgical GownFYA · Traditional | Cardinal Health200, LLC | 06/09/2017SE |
| K162930 | Aero Chrome* Select Breathable Performance Surgical GownsFYA · Traditional | Halyard Health, Inc. | 04/21/2017SE |
| K163191 | ComfortGuard Surgical Gown, i600, Film ReinforcedFYA · Traditional | Gri Medical & Electrical Technology Co., Ltd. | 02/27/2017SE |
| K162442 | ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500FYA · Traditional | Gri Medical & Electrical Technology Co., Ltd. | 12/12/2016SE |
| K150598 | Blockade Surgical GownFYA · Traditional | Medline Industries, Inc. | 04/28/2016SE |
| K153255 | Aero Chrome* Breathable Performance Surgical GownFYA · Traditional | Halyard Health, Inc. | 04/13/2016SE |
| K133075 | Plus Surgical Gowns (EO Sterilized), PMGB-XXXFYA · Traditional | Foshan Nanhai Plus Medical Co, Ltd. | 06/24/2015SE |
| K150151 | SmartGownTM surgical gownFYA · Traditional | Cardinal Health 200, Inc. | 05/21/2015SE |
| K141467 | Surgical GownFYA · Traditional | Xuchang Zhengde Environstar Medical Products Co.,L | 03/05/2015SE |
| K141606 | Surgical GownFYA · Traditional | Cobes Industries Co., Ltd. | 11/17/2014SE |
| K142166 | Total Shield Surgical;Toga(Regular, Large,X-Large);Hood; Helmet Advanced Helmet W/Led…FYA · Special | Zimmer, Inc. | 08/28/2014SE |
| K141095 | Stryker Steri-Shield Flyte Hybrid TogasFYA · Special | Stryker Corporation | 08/26/2014SE |
| K140539 | Aero Blue Performance Surgical GownFYA · Abbreviated | Kimberly-Clark Corporation | 06/09/2014SE |
| K121664 | T4/T5 Hytrel TogasFYA · Traditional | Stryker Corporation | 03/10/2014SE |
| K132386 | Totalshield Surgical Helmet SystemFYA · Traditional | Zimmer, Inc. | 12/23/2013SE |
| K112796 | Surgical Gown (Eo Sterilized)FYA · Traditional | Cobes Industries Co., Ltd. | 09/12/2013SE |
| K121998 | HM Surgical Gown, Non Reinforced HM Surgical Gown, Fabric Reinforced HM Surgical Gown…FYA · Traditional | Changzhou Holymed Products Co., Ltd. | 12/20/2012SE |
| K121152 | Surgical Gown, SMSFYA · Abbreviated | Jiangsu Guangda Medical Material, Co., Ltd. | 12/12/2012SE |
| K120192 | Disposable Surgical GownsFYA · Traditional | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 10/16/2012SE |
| K120045 | Emm High Performance Surgical Gown with Aami Liquid Barrier Level IVFYA · Traditional | Exact Medical Manufacturing, Inc. | 06/12/2012SE |
| K111535 | Emm Surgical Gown - Spunlace with Pe LayerFYA · Traditional | Exact Medical Manufacturing, Inc. | 08/26/2011SE |
| K111067 | Jie+Hong Medical Surgical Gowns - Sterile, Jie+Hong Medical Surgical Gowns - Non SterileFYA · Traditional | Kunshan Jiehong Nonwoven Product Co., Ltd. | 08/02/2011SE |
| K110724 | Surgical Procedure PacksFYA · Traditional | Omnia Spa | 06/23/2011SE |
| K101468 | 3M Basic Disposable Surgical Gown, 3M HP Disposable Surgical Gown, 3M Reinforced…FYA · Traditional | 3M Company Corp | 04/14/2011SE |
| K102692 | SMS Gowns (Reinforced and Reinforced with Guider), Spunlace Gowns (Regular, Regular with…FYA · Traditional | Hangzhou Jincheng Medical Supplier Manufacture Co. | 03/11/2011SE |
| K102971 | Freedomaire III Surgical Helmet System Model 10322STKFYA · Traditional | Microtek Medical, Inc. | 02/23/2011SE |
| K093835 | Bam Standard Surgical Gown, Bam Reinforced Surgical Gown, Bam Ultra Reinforced Surgical…FYA · Abbreviated | Bam Corp., Ltd. | 02/04/2011SE |
| K102652 | Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced…FYA · Traditional | Gri Medical & Electronic Technology Co., Ltd. | 02/03/2011SE |
| K103406 | Microcool Breathable High Performance Surgical GownsFYA · Traditional | Kimberly-Clark Corp. | 12/23/2010SE |
| K100971 | Atek Surgical GownsFYA · Traditional | Hangzhou Atek Medical & Textile Co., Ltd. | 09/27/2010SE |
| K101593 | Emm Surgical Gown-Sms with Pe Layer, Model 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXLFYA · Traditional | Exact Medical Manufacturing, Inc. | 09/03/2010SE |
| K093115 | Kimberly-Clark KC100 Surgical Gown, Model KC100FYA · Traditional | Kimberly-Clark Corp. | 03/19/2010SE |
| K092344 | Lac-Mac Innerbloc LR Surgical GownsFYA · Abbreviated | Lac Mac, Ltd. | 12/17/2009SE |
| K093169 | Surgiplus Standard Surgical Gown (Sterile) ( Non Sterile), Reinforced Surgical Gown…FYA · Traditional | A Plus International, Inc. | 11/12/2009SE |
| K091357 | Microcool Surgical Gown, Breathable High Performance KC400FYA · Abbreviated | Kimberly-Clark Corp. | 08/10/2009SE |
| K090383 | Sri Level II Surgical GownFYA · Abbreviated | Sri Surgical | 05/29/2009SE |
| K091097 | Promedical Surgical Gown, Models 18-301, 18-401 and 18-501FYA · Special | Promedical Products Co., Ltd. | 05/27/2009SE |
| K082479 | Sklar Surgical GownFYA · Traditional | Sklar Corp. | 04/24/2009SE |
| K080723 | Sri LP GownFYA · Abbreviated | Sri/Surgical Express, Inc. | 11/13/2008SE |
| K080707 | Sri PLR GownFYA · Abbreviated | Sri/Surgical Express | 11/13/2008SE |
| K080795 | Ultra Surgical Gown & Fluid Barrier Surgical GownFYA · Abbreviated | Kimberly-Clark Corp. | 09/03/2008SE |
| K080627 | Promedical Surgical Gowns, Models: 1002494A, 100770AFYA · Special | Promedical Products Co., Ltd. | 04/24/2008SE |
| K073017 | Stryker Stri-Shield Flyte TogasFYA · Special | Stryker Instruments, Instruments Div. | 11/30/2007SE |
| K070431 | Welmed, Inc. Surgical GownsFYA · Traditional | Welmed, Inc. | 05/24/2007SE |
| K063005 | Stryker T6 Hoods and TogasFYA · Traditional | Stryker Instruments | 03/23/2007SE |
| K062479 | Joykey Surgical Gowns (Sterile)FYA · Traditional | Joykey Industryial , Ltd. | 03/14/2007SE |
| K070078 | Stryker T4 Hytrel TogaFYA · Special | Stryker Instruments, Instruments Div. | 02/02/2007SE |
| K062899 | Microtek Medical Surgical Gown/TogaFYA · Traditional | Microtek Medical, Inc. | 01/25/2007SE |
| K062969 | Medline Sterile Disposable Surgical GownsFYA · Special | Medline Industries, Inc. | 12/14/2006SE |
| K061491 | Lac-Mac Innerbloc O.R. GownFYA · Abbreviated | Lac Mac, Ltd. | 08/09/2006SE |
| K061308 | Trimax, Model 9515N, Breathable Surgical Gown, Models 3247AN and 9015N and Optima or…FYA · Special | Cardinal Health 200, Inc. | 06/05/2006SE |
| K052824 | Kimberly-Clark Procedure GownFYA · Traditional | Kimberly-Clark Corp. | 05/02/2006SE |
| K060181 | COMPE1 1 -Ply Surgical GownsFYA · Traditional | Standard Textile Co., Inc. | 03/07/2006SE |
| K052550 | Imc Surgical GownsFYA · Traditional | Intl. Medsurg Connection, Inc. | 11/17/2005SE |
| K051426 | Carlo Surgical GownFYA · Traditional | Sofilm Technology Co., Ltd. | 08/02/2005SE |
| K041653 | Compel 1-PLY Surgical Gowns; Compel Isolation GownsFYA · Traditional | Standard Textile Co., Inc. | 07/01/2005SE |
| K050786 | Barrier Surgical GownsFYA · Special | Molnlycke Health Care | 05/09/2005SE |
| K041540 | Combosafe (Europe) and Promax (US) Surgical GownsFYA · Traditional | Standard Textile Co., Inc. | 05/05/2005SE |
| K041539 | Compel Surgical GownsFYA · Traditional | Standard Textile Co., Inc. | 04/28/2005SE |
| K043004 | Stackhouse Freedomaire II Surgical Helmet System, Models 12000, 12010, 12011, 12020…FYA · Traditional | Viasys Medsystems | 03/16/2005SE |
| K041541 | Compel MLR Surgical GownsFYA · Traditional | Standard Textile Co., Inc. | 03/16/2005SE |
| K043585 | Medline Surgical GownsFYA · Traditional | Medline Industries, Inc. | 03/08/2005SE |
| K043017 | Prevention Breathable, Impervious Surgical GownsFYA · Traditional | Medline Industries, Inc. | 03/08/2005SE |
| K042111 | Promedical Surgical GownsFYA · Traditional | Promedical Products Co., Ltd. | 12/10/2004SE |
| K040485 | Maxair Surgical Helmet SystemFYA · Traditional | Bio-Medical Devices, Inc. | 10/18/2004SE |
| K040764 | Stryker T4 Hytrel Zipper TogaFYA · Special | Stryker Corp. | 04/27/2004SE |
| K032631 | Innerbloc LR Surgical Gowns Based on Gore LR Fabric (Reusable 100X)FYA · Traditional | Lac Mac, Ltd. | 02/05/2004SE |
| K033057 | Deroyal Surgical Gowns, Sterile, Non-SterileFYA · Traditional | Deroyal | 11/20/2003SE |
| K031408 | Deroyal Poly-Reinforced Surgical Gowns (Sterile, Non-Sterile)FYA · Traditional | Deroyal | 10/15/2003SE |
| K031933 | Medline Reusable Surgical Gowns (100X)FYA · Traditional | Medline Industries, Inc. | 09/16/2003SE |
| K030536 | Lac-Mac Limited Innerbloc O.R. GownFYA · Traditional | Lac Mac, Ltd. | 05/06/2003SE |
| K030364 | Deroyal Gowns, Sterile, Non-SterileFYA · Traditional | Deroyal Industries, Inc. | 04/28/2003SE |
| K021992 | DHS Disposable Hood SystemFYA · Traditional | Biomet, Inc. | 01/14/2003SE |
| K023635 | Sri/Surgical Express SP Reusable Surgical GownFYA · Traditional | Sri/Surgical Express, Inc. | 11/18/2002SE |
| K023266 | Primagard Surgical GownsFYA · Traditional | Primeline Medical Products, Inc. | 11/08/2002SE |
| K023167 | Breathable Surgical GownFYA · Special | Allegiance Healthcare Corp. | 10/02/2002SE |
| K022162 | Stryker T4 Urethane Hood; Stryker T4 Urethane Zipper Toga; Stryker T4 Urethane Pullover…FYA · Special | Stryker Instruments | 08/01/2002SE |
| K013846 | Ultragard Impervious Reinforced GownFYA · Traditional | Precept Medical Products, Inc. | 05/22/2002SE |
| K020593 | Convertors SMS Polyolefin GownFYA · Special | Allegiance Healthcare Corp. | 03/18/2002SE |
| K012186 | Master & Frank Surgical Gowns (Sterile)FYA · Traditional | Master & Frank Ent. Co., Ltd. | 12/07/2001SE |
| K012268 | TrimaxFYA · Traditional | Standard Textile Co., Inc. | 12/03/2001SE |
| K012240 | Mertex-Plus O.R./Surgeons Gown, NonsterileFYA · Traditional | Mercan AB | 10/15/2001SE |
| K012984 | Breathable Impervious GownsFYA · Special | Allegiance Healthcare Corp. | 09/24/2001SE |
| K010799 | Combosafe Surgical Gowns, Non-Sterile (75X Reusable)FYA · Traditional | Standard Textile Co., Inc. | 06/07/2001SE |
| K003755 | Medline Blockade or Resistat Surgical Gowns and Surggical DrapesFYA · Traditional | Medline Industries, Inc. | 02/16/2001SE |
| K003194 | Stackhouse Lens Hood, Model SA-700/FSFYA · Special | Stackhouse, Inc. | 10/26/2000SE |
| K000605 | Stackhouse Lens Hood, Model SA-700/FFYA · Traditional | Stackhouse, Inc. | 08/17/2000SE |
| K000902 | Klinidrape Reinforced Surgical GownsFYA · Traditional | Molnlycke Health Care, Inc. | 07/11/2000SE |
| K000901 | Klinidrape Surgical Gowns, Non-Reinforced, Basic Protections and Standard ProtectionFYA · Traditional | Molnlycke Health Care, Inc. | 07/05/2000SE |
| K001189 | Modification to Convertors Surgical GownsFYA · Special | Allegiance Healthcare Corp. | 04/21/2000SE |
| K993170 | Medline Breathable, Impervious Disposable Surgical GownsFYA · Traditional | Medline Industries, Inc. | 03/02/2000SE |
| K994244 | Convertors Surgical Gowns, SterileFYA · Traditional | Allegiance Healthcare Corp. | 02/18/2000SE |
| K992445 | Med-Guard Surgeon's GownFYA · Traditional | Kappler USA | 02/18/2000SE |
| K992436 | Gown Back, Model 13-403N; 13-404N; 13-405NFYA · Traditional | Techstyles | 01/20/2000SE |
| K994053 | Stryker T4 Power Pack, Stryker T4 Eight Station Battery Charger, Stryker T4 Charger ModuleFYA · Special | Stryker Instruments | 12/20/1999SE |
| K993148 | Stryker T4 Hood, Stryker T4 Zippered Toga, Stryker T4 Pullover TogaFYA · Special | Stryker Instruments | 10/15/1999SE |
| K992951 | Convertors Surgical GownsFYA · Special | Allegiance Healthcare Corp. | 09/22/1999SE |
| K992514 | Convertors Breathable Surgical GownsFYA · Special | Allegiance Healthcare Corp. | 08/12/1999SE |
| K991034 | Convertors Surgical GownsFYA · Special | Allegiance Healthcare Corp. | 04/16/1999SE |
| K990395 | Barrier Surgical GownsFYA · Traditional | Johnson & Johnson Medical, Div. of Ethicon, Inc. | 04/13/1999SE |
| K984422 | Sterile Back Surgical Gown with Hand TowelFYA · Traditional | Medical Sterilization, Inc. | 04/02/1999SE |
| K982058 | Rotecno FR (Fluid Resistant) Surgical GownFYA · Traditional | Encompass Group, LLC | 01/14/1999SE |
| K982694 | Medline Medcrest Surgical Gowns and Surgical DrapesFYA · Traditional | Medline Industries, Inc. | 12/14/1998SE |
| K982059 | Rotecno 2000 Surgical GownFYA · Traditional | Encompass Group, LLC | 11/30/1998SE |
| K982693 | Medine Disposable Sterile Zoned Impervious Surgical GownsFYA · Traditional | Medline Industries, Inc. | 10/28/1998SE |
| K981393 | Microcool Surgical GownFYA · Traditional | Kimberly-Clark Corp. | 07/10/1998SE |
| K981073 | Medcom Gown Pack, Medcom Drape Pack & Medcom Towel PackFYA · Traditional | Medcom Laundry Service, Inc. | 05/15/1998SE |
| K971920 | Gown Poly Reinforced Large(Product NO.900-522)/(REORDER No. 0522)FYA · Traditional | Customed, Inc. | 12/04/1997SE |
| K972832 | Provision Surgical Helmet SystemFYA · Traditional | Depuy, Inc. | 10/21/1997SE |
| K970893 | Ultrasound Transducer DrapeFYA · Traditional | Protek Medical Products, Inc. | 10/20/1997SE |
| K962666 | Bemiss Jason-Sterile,Non-Sterile,Reinforced Sterile,And Reinforced Non-Sterile Surgical…FYA · Traditional | Bemiss-Jason Corp., Triad Medical Div. | 02/27/1997SE |
| K954674 | P1OP2B or P1O92TFYA · Traditional | Kay Borch A/S | 01/30/1997SE |
| K963809 | Cool-ZoneFYA · Traditional | Kappler USA | 11/20/1996SE |
| K961341 | Convertors Polyolefin Fabric GownsFYA · Traditional | Baxter Healthcare Corp | 10/28/1996SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1563-2026 Class II | Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5…Fabric may experience premature delamination when using included laundering instructions. Identifying… | Medline Industries, LP | 01/28/2026Open, Classified |
| Z-2130-2026 Class II | Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-2129-2026 Class II | See complete list in RES, exceeds character limit. Medline Surgical GownsMedline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-1424-2026 Class II | Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | Medline Industries, LP | 01/07/2026Open, Classified |
| Z-0897-2026 Class II | ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage…Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of… | Cardinal Health 200, LLC | 11/12/2025Open, Classified |
| Z-0711-2024 Class II | Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS…Surgical gowns were manufactured with the wrong sleeve. | MEDLINE INDUSTRIES, LP - Northfield | 11/29/2023Open, Classified |
| Z-0343-2023 Class II | Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery… | Owens & Minor Distribution, Inc. | 10/31/2022Open, Classified |
| Z-0242-2023 Class II | Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B…Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the fabric does… | Texas Medical Technology Inc. | 09/01/2022Open, Classified |
| Z-0378-2022 Class II | RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998Potential for open packaging seals compromising the sterility of the surgical gowns | Cardinal Health | 11/02/2021Open, Classified |
| Z-0377-2022 Class II | RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578Potential for open packaging seals compromising the sterility of the surgical gowns | Cardinal Health | 11/02/2021Open, Classified |
| Z-0376-2022 Class II | RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548Potential for open packaging seals compromising the sterility of the surgical gowns | Cardinal Health | 11/02/2021Open, Classified |
| Z-0375-2022 Class II | RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518Potential for open packaging seals compromising the sterility of the surgical gowns | Cardinal Health | 11/02/2021Open, Classified |
| Z-0374-2022 Class II | Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070Potential for open packaging seals compromising the sterility of the surgical gowns | Cardinal Health | 11/02/2021Open, Classified |
| Z-0373-2022 Class II | Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040Potential for open packaging seals compromising the sterility of the surgical gowns | Cardinal Health | 11/02/2021Open, Classified |
| Z-0372-2022 Class II | Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010Potential for open packaging seals compromising the sterility of the surgical gowns | Cardinal Health | 11/02/2021Open, Classified |
| Z-0371-2022 Class II | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041ELPotential for open packaging seals compromising the sterility of the surgical gowns | Cardinal Health | 11/02/2021Open, Classified |
| Z-0370-2022 Class II | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041Potential for open packaging seals compromising the sterility of the surgical gowns | Cardinal Health | 11/02/2021Open, Classified |
| Z-0369-2022 Class II | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011Potential for open packaging seals compromising the sterility of the surgical gowns | Cardinal Health | 11/02/2021Open, Classified |
| Z-0368-2022 Class II | SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474Potential for open packaging seals compromising the sterility of the surgical gowns | Cardinal Health | 11/02/2021Open, Classified |
| Z-0296-2021 Class II | LOM Disposable Surgical Gowns/Medical Gowns, Single-UseMedical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet… | Thread Counsel Inc Dba Laws of Motion | 09/17/2020Open, Classified |
| Z-1040-2020 Class II | AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1039-2020 Class II | AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1038-2020 Class II | AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1037-2020 Class II | AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1036-2020 Class II | AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541ELThe gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1035-2020 Class II | AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1034-2020 Class II | AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1033-2020 Class II | AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1032-2020 Class II | GOWN SURG LG W/TOWEL ST BACK, Item Code 9515The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1031-2020 Class II | AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1030-2020 Class II | AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1029-2020 Class II | AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575ELThe gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1028-2020 Class II | AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1027-2020 Class II | ROYALSILK XLARGE, Gown. Item Code 9548The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1026-2020 Class II | AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1025-2020 Class II | AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1024-2020 Class II | ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1023-2020 Class II | ROYALSILK 2XLARGE, Gown. Item Code 9578The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1022-2020 Class II | ROYALSILK LARGE, Gown. Item Code 9518The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1021-2020 Class II | AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585NThe gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1020-2020 Class II | AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNAThe gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1019-2020 Class II | AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NCThe gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1018-2020 Class II | AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NBThe gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1017-2020 Class II | AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NAThe gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1016-2020 Class II | AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NBThe gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1015-2020 Class II | AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995NThe gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1014-2020 Class II | ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998NThe gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1013-2020 Class II | AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NBThe gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1012-2020 Class II | AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NCThe gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |
| Z-1011-2020 Class II | AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NCThe gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate… | Cardinal Health | 01/11/2020Terminated |