| Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) (K261028) | Yadu Medical (Henan) Co., Ltd. | 2026-08-07 |
| NYES Tuff Cuff L3 Disposable Gowns (K261949) | New York Embroidery Studio | 2026-07-10 |
| Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) (K252575) | New York Embroidery Studio (NYES) | 2026-06-04 |
| BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) (K260725) | Hindernis DE Mexico, S.A.P.I. DE C.V. | 2026-05-12 |
| Cardinal Health™ Poly Reinforced Surgical Gown (K253243) | Cardinal Health 200, LLC | 2026-04-28 |
| Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) (K253003) | Hubei Xinxin Non-Woven Co., Ltd. | 2026-04-20 |
| Copioumed AAMI 3 Surgical Gown (K251860) | Copioumed International, Inc. | 2026-02-26 |
| Henan Yadu Level 4 Surgical Gowns (Reinforced) (K252301) | Yadu Medical (Henan) Co., Ltd. | 2026-02-04 |
| Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) (K250564) | Yadu Medical (Henan) Co., Ltd. | 2025-12-03 |
| ViVi® Toga Premium (K243522) | Thi Total Healthcare Innovation GmbH | 2025-05-30 |
| Dream Medi Sterile Surgical Gown (SurgicalGownUL) (K242937) | Dae Myung Chemical Co., Ltd. (Vietnam) | 2025-05-05 |
| Medline Level 4 Surgical Gown with Breathable Sleeves (K242844) | Medline Industries, LP | 2025-02-26 |
| Stryker Steri-Shield 8 Surgical Hoods and Togas (K241272) | Stryker Instruments | 2024-10-16 |
| ProPel SG3™ Surgical Gown (K241214) | Standard Textile Co., Inc. | 2024-09-10 |
| GCI Surgical Gown (K233571) | George Courey, Inc. | 2024-08-02 |
| Disposable Surgical Gown (K233068) | Nanning Tecbod Biological Technology Co., Ltd. | 2024-03-29 |
| Surgical Gown (40083) (K233183) | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. | 2024-02-01 |
| Skypro, Surgical Gown 6021 (K230707) | Skypro Medical Supplies Company | 2023-10-12 |
| Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) (K230610) | Dongguan Shin YI Healthcare Products Factory | 2023-08-23 |
| Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) (K231510) | Xiantao Zhibo Non-Woven Products Co., Ltd. | 2023-08-22 |
| Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) (K230577) | Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi | 2023-08-16 |
| Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets (K230838) | Cardinal Health200, LLC | 2023-07-27 |
| Surgical Gown (K222999) | Hubei Woozon Healthcare Co., Ltd. | 2023-06-16 |
| High Protection Surgical Gown (K222456) | 3A Medical Products Co., Ltd. | 2023-03-12 |
| Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) (K223401) | Xiamen Probtain Medical Techology Co., Ltd. | 2023-03-07 |
| Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 (K221559) | Stringking | 2023-02-23 |
| Surgical Gown (K213844) | Bayteks Teknik Tekstil San. VE Tic. A.S. | 2023-02-16 |
| SEJONG Surgical Gown Soft (K220435) | Sejong Healthcare Co., Ltd. | 2023-02-10 |
| Surgical Gown (K222403) | Guangzhou Fuzelong Hygiene Material Co., Ltd. | 2023-01-26 |
| Comfort Gown, Safewear Gown (K213893) | Xuchang Zhengde Environstar Medical Products Co., Ltd. | 2022-12-21 |
| Surgical Gown (K212812) | Xianning Marveldas Protective Articles Co., Ltd. | 2022-11-16 |
| Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) (K222480) | Foshan Nanhai Plus Medical Co, Ltd. | 2022-11-14 |
| Bodygard SFS Surgical Gown Level 4 (K221139) | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri | 2022-11-10 |
| Disposable Surgical Gown Rk-3011C (K211060) | Xiantao Rhycom Non-Woven Products Co., Ltd. | 2022-10-28 |
| Disposable Surgical Gown (G4003) (K221977) | Xiantao Topmed Nonwoven Protective Products Co., Ltd. | 2022-10-20 |
| YADU Surgical Gowns (K220092) | Henan Yadu Industrial Co., Ltd. | 2022-10-07 |
| Surgical Gown (Sterile); Surgical Gown (Non-sterile) (K221637) | Allmed Medical (Hubei) Protective Products Co., Ltd. | 2022-09-29 |
| Disposable Surgical Gown UM-148 (K221717) | Unimax Medical Products Co., Ltd. | 2022-09-20 |
| 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown (K221819) | Winner Medical Co., Ltd. | 2022-09-19 |
| Sterile Level 3 Surgical Gown (K211399) | Barco Tekstil Sanayi VE Ticaret A.S. | 2022-07-22 |
| Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile (K220665) | Excellent Medical Technology Group Co., Ltd. | 2022-06-03 |
| Medline Orbis LVL 3 Surgical Gown (K220333) | Medline Industries, LP | 2022-05-18 |
| Plus Medical Cover Gown (K213177) | Foshan Nanhai Plus Medical Co, Ltd. | 2022-05-11 |
| Medline Orbis Chemo Surgical Gown (K214108) | Medline Industries, LP | 2022-05-06 |
| Plus Medical Chemotherapy Gown (K211036) | Foshan Nanhai Plus Medical Co, Ltd. | 2022-05-04 |
| Disposable Surgical Gown (K214088) | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2022-04-12 |
| Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown (K203237) | Dukal Corporation | 2022-03-18 |
| Maxima Surgical Gown (K201351) | Elevate Textiles | 2022-03-11 |
| Surgical Gown (K213703) | Wujiang Tutaike Textiles & Finishing Co., Ltd. | 2022-03-04 |
| Bodygard SFS Surgical Gown Level 3 (K202845) | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi | 2022-02-24 |
| EndoArmor™ + Surgical Gown (K203548) | Boston Scientific Corporation | 2022-02-21 |
| Surgical gowns (K212718) | Xiantao Dingcheng Non-Woven Product Co., Ltd. | 2022-01-12 |
| Disposable Surgical Gown (K212591) | Suzhou Janee Medical Technology Co., Ltd. | 2022-01-11 |
| Surgical Gown, Model: surgical gown-hp-3 (K210355) | Weihai Dishang Medical Technology Co., Ltd. | 2021-12-16 |
| Surgical Gown, Reinforced Surgical Gown (K212861) | Wuhan Zonsen Medical Products Co., Ltd. | 2021-12-15 |
| Disposable Surgical Gown, Disposable Reinforced Surgical Gown (K212869) | Fugou County Shenxiang Manufacturing Co., Ltd. | 2021-12-13 |
| Disposable Surgical Gown (K212925) | Henan Robestain Medical Products Co., Ltd. | 2021-12-13 |
| Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) (K203539) | Unicoglobal, Inc. | 2021-12-10 |
| Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown (K211765) | Cardinal Health, LLC | 2021-11-23 |
| Surgical Gown (K211509) | Hubei Wanli Protective Products Co., Ltd. | 2021-10-24 |
| Surgical Gown (K211809) | Wuhan Dymex Healthcare Co., Ltd. | 2021-10-18 |
| Surgical Gown (K211077) | Wujiang Tutaike Textiles & Finishing Co., Ltd. | 2021-10-07 |
| Disposable Surgical Gowns (K202532) | Anhui Medpurest Medical Technology Co.,Ltd | 2021-08-21 |
| Disposable Surgical Gown (K210510) | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-08-12 |
| Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) (K210143) | Foshan Nanhai Plus Medical Co, Ltd. | 2021-07-22 |
| AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown (K210688) | O&M Halyard, Inc. | 2021-07-21 |
| Surgical Gowns (K210215) | Jiangsu Province Jianerkang Medical Dressing Co., Ltd. | 2021-07-07 |
| Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown (K211422) | Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. | 2021-07-02 |
| Medline Orbis Surgical Gown (K202447) | Medline Industries, Inc. | 2021-04-02 |
| Medical Surgical Gowns (K202844) | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2021-01-06 |
| Surgical Gown (Sterile), Surgical Gown (Non-sterile) (K202706) | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2020-12-31 |
| Modular Toga (K200977) | Operating Room Innovations, Inc. | 2020-08-05 |
| Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown (K200824) | Cardinal Health200, LLC | 2020-07-29 |
| Surgical Gown (K192560) | Shandong Kangli Medical Equipment Technology Co., Ltd. | 2020-05-22 |
| 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown (K192290) | Xuchang Zhengde Environstar Medical Products Co., Ltd. | 2020-04-30 |
| Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve (K193327) | Cardinal Health200, LLC | 2020-03-20 |
| AERO CHROME* Breathable Performance Surgical Gowns (K200522) | O&M Halyard, Inc. | 2020-03-16 |
| Aero Blue Performance Surgical Gowns (K192362) | O&M Halyard, Inc. | 2019-12-13 |
| TotalShield II Surgical Helmet System (K192194) | Zimmer Surgical, Inc. | 2019-10-15 |
| Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) (K190950) | Medline Industries, Inc. | 2019-07-04 |
| Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) (K182172) | Medline Industries, Inc. | 2019-04-24 |
| Disposable Ultra Reinforced Surgical Gown (K173847) | Xiantao Rayxin Medical Products Co., Ltd. | 2019-01-16 |
| Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) (K172987) | Gmax Industries, Inc. | 2018-07-13 |
| Medline Prevention CoolZone Gown (K172954) | Medline Industries, Inc. | 2018-06-15 |
| RoyalGuard Surgical Gown, i600, Breathable (K172445) | Gri Medical & Electrical Technology Co., Ltd. | 2017-12-08 |
| Cardinal Health Non-Reinforced Surgical Gown (K170762) | Cardinal Health200, LLC | 2017-06-09 |
| Aero Chrome* Select Breathable Performance Surgical Gowns (K162930) | Halyard Health, Inc. | 2017-04-21 |
| ComfortGuard Surgical Gown, i600, Film Reinforced (K163191) | Gri Medical & Electrical Technology Co., Ltd. | 2017-02-27 |
| ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 (K162442) | Gri Medical & Electrical Technology Co., Ltd. | 2016-12-12 |
| Blockade Surgical Gown (K150598) | Medline Industries, Inc. | 2016-04-28 |
| Aero Chrome* Breathable Performance Surgical Gown (K153255) | Halyard Health, Inc. | 2016-04-13 |
| Plus Surgical Gowns (EO Sterilized), PMGB-XXX (K133075) | Foshan Nanhai Plus Medical Co, Ltd. | 2015-06-24 |
| SmartGownTM surgical gown (K150151) | Cardinal Health 200, Inc. | 2015-05-21 |
| SURGICAL GOWN (K141467) | Xuchang Zhengde Environstar Medical Products Co.,L | 2015-03-05 |
| SURGICAL GOWN (K141606) | Cobes Industries Co., Ltd. | 2014-11-17 |
| TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES (K142166) | Zimmer, Inc. | 2014-08-28 |
| STRYKER STERI-SHIELD FLYTE HYBRID TOGAS (K141095) | Stryker Corporation | 2014-08-26 |
| AERO BLUE PERFORMANCE SURGICAL GOWN (K140539) | Kimberly-Clark Corporation | 2014-06-09 |
| T4/T5 HYTREL TOGAS (K121664) | Stryker Corporation | 2014-03-10 |
| TOTALSHIELD SURGICAL HELMET SYSTEM (K132386) | Zimmer, Inc. | 2013-12-23 |