FDA Product Code
FDA Product Code FYA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4040
510(k) Clearances — 298 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260407 | Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns | Principle & Will Co., Ltd. | 2026-08-26 | Traditional | PDF ↗ |
| K261028 | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | 2026-08-07 | Traditional | PDF ↗ |
| K261949 | NYES Tuff Cuff L3 Disposable Gowns | New York Embroidery Studio | 2026-07-10 | Special | PDF ↗ |
| K252575 | Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) | New York Embroidery Studio (NYES) | 2026-06-04 | Traditional | PDF ↗ |
| K260725 | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) | Hindernis DE Mexico, S.A.P.I. DE C.V. | 2026-05-12 | Traditional | PDF ↗ |
| K253243 | Cardinal Health Poly Reinforced Surgical Gown | Cardinal Health 200, LLC | 2026-04-28 | Abbreviated | PDF ↗ |
| K253003 | 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) | Hubei Xinxin Non-Woven Co., Ltd. | 2026-04-20 | Traditional | PDF ↗ |
| K251860 | Copioumed AAMI 3 Surgical Gown | Copioumed International, Inc. | 2026-02-26 | Traditional | PDF ↗ |
| K252301 | Henan Yadu Level 4 Surgical Gowns (Reinforced) | Yadu Medical (Henan) Co., Ltd. | 2026-02-04 | Traditional | PDF ↗ |
| K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | 2025-12-03 | Traditional | PDF ↗ |
| K243522 | ViVi® Toga Premium | Thi Total Healthcare Innovation GmbH | 2025-05-30 | Traditional | PDF ↗ |
| K242937 | Dream Medi Sterile Surgical Gown (SurgicalGownUL) | Dae Myung Chemical Co., Ltd. (Vietnam) | 2025-05-05 | Traditional | PDF ↗ |
| K242844 | Medline Level 4 Surgical Gown with Breathable Sleeves | Medline Industries, LP | 2025-02-26 | Traditional | PDF ↗ |
| K241272 | Stryker Steri-Shield 8 Surgical Hoods and Togas | Stryker Instruments | 2024-10-16 | Traditional | PDF ↗ |
| K241214 | ProPel SG3 Surgical Gown | Standard Textile Co., Inc. | 2024-09-10 | Traditional | PDF ↗ |
| K233571 | GCI Surgical Gown | George Courey, Inc. | 2024-08-02 | Traditional | PDF ↗ |
| K233068 | Disposable Surgical Gown | Nanning Tecbod Biological Technology Co., Ltd. | 2024-03-29 | Traditional | PDF ↗ |
| K233183 | Surgical Gown (40083) | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. | 2024-02-01 | Traditional | PDF ↗ |
| K230707 | Skypro, Surgical Gown 6021 | Skypro Medical Supplies Company | 2023-10-12 | Traditional | PDF ↗ |
| K230610 | Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) | Dongguan Shin YI Healthcare Products Factory | 2023-08-23 | Traditional | PDF ↗ |
| K231510 | Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) | Xiantao Zhibo Non-Woven Products Co., Ltd. | 2023-08-22 | Traditional | PDF ↗ |
| K230577 | Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) | Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi | 2023-08-16 | Traditional | PDF ↗ |
| K230838 | Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets | Cardinal Health200, LLC | 2023-07-27 | Traditional | PDF ↗ |
| K222999 | Surgical Gown | Hubei Woozon Healthcare Co., Ltd. | 2023-06-16 | Traditional | PDF ↗ |
| K222456 | High Protection Surgical Gown | 3A Medical Products Co., Ltd. | 2023-03-12 | Traditional | PDF ↗ |
| K223401 | Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Techology Co., Ltd. | 2023-03-07 | Traditional | PDF ↗ |
| K221559 | Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 | Stringking | 2023-02-23 | Traditional | PDF ↗ |
| K213844 | Surgical Gown | Bayteks Teknik Tekstil San. VE Tic. A.S. | 2023-02-16 | Traditional | PDF ↗ |
| K220435 | SEJONG Surgical Gown Soft | Sejong Healthcare Co., Ltd. | 2023-02-10 | Traditional | PDF ↗ |
| K222403 | Surgical Gown | Guangzhou Fuzelong Hygiene Material Co., Ltd. | 2023-01-26 | Traditional | PDF ↗ |
| K213893 | Comfort Gown, Safewear Gown | Xuchang Zhengde Environstar Medical Products Co., Ltd. | 2022-12-21 | Traditional | PDF ↗ |
| K212812 | Surgical Gown | Xianning Marveldas Protective Articles Co., Ltd. | 2022-11-16 | Traditional | PDF ↗ |
| K222480 | Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) | Foshan Nanhai Plus Medical Co, Ltd. | 2022-11-14 | Traditional | PDF ↗ |
| K221139 | Bodygard SFS Surgical Gown Level 4 | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri | 2022-11-10 | Traditional | PDF ↗ |
| K211060 | Disposable Surgical Gown Rk-3011C | Xiantao Rhycom Non-Woven Products Co., Ltd. | 2022-10-28 | Traditional | PDF ↗ |
| K221977 | Disposable Surgical Gown (G4003) | Xiantao Topmed Nonwoven Protective Products Co., Ltd. | 2022-10-20 | Traditional | PDF ↗ |
| K220092 | YADU Surgical Gowns | Henan Yadu Industrial Co., Ltd. | 2022-10-07 | Traditional | PDF ↗ |
| K221637 | Surgical Gown (Sterile); Surgical Gown (Non-sterile) | Allmed Medical (Hubei) Protective Products Co., Ltd. | 2022-09-29 | Traditional | PDF ↗ |
| K221717 | Disposable Surgical Gown UM-148 | Unimax Medical Products Co., Ltd. | 2022-09-20 | Traditional | PDF ↗ |
| K221819 | 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 | Winner Medical Co., Ltd. | 2022-09-19 | Traditional | PDF ↗ |
| K211399 | Sterile Level 3 Surgical Gown | Barco Tekstil Sanayi VE Ticaret A.S. | 2022-07-22 | Traditional | PDF ↗ |
| K220665 | Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile | Excellent Medical Technology Group Co., Ltd. | 2022-06-03 | Traditional | PDF ↗ |
| K220333 | Medline Orbis LVL 3 Surgical Gown | Medline Industries, LP | 2022-05-18 | Traditional | PDF ↗ |
| K213177 | Plus Medical Cover Gown | Foshan Nanhai Plus Medical Co, Ltd. | 2022-05-11 | Traditional | PDF ↗ |
| K214108 | Medline Orbis Chemo Surgical Gown | Medline Industries, LP | 2022-05-06 | Traditional | PDF ↗ |
| K211036 | Plus Medical Chemotherapy Gown | Foshan Nanhai Plus Medical Co, Ltd. | 2022-05-04 | Traditional | PDF ↗ |
| K214088 | Disposable Surgical Gown | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2022-04-12 | Traditional | PDF ↗ |
| K203237 | 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 | Dukal Corporation | 2022-03-18 | Traditional | PDF ↗ |
| K201351 | Maxima Surgical Gown | Elevate Textiles | 2022-03-11 | Traditional | PDF ↗ |
| K213703 | Surgical Gown | Wujiang Tutaike Textiles & Finishing Co., Ltd. | 2022-03-04 | Traditional | PDF ↗ |
| K202845 | Bodygard SFS Surgical Gown Level 3 | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi | 2022-02-24 | Traditional | PDF ↗ |
| K203548 | EndoArmor + Surgical Gown | Boston Scientific Corporation | 2022-02-21 | Traditional | PDF ↗ |
| K212718 | Surgical gowns | Xiantao Dingcheng Non-Woven Product Co., Ltd. | 2022-01-12 | Traditional | PDF ↗ |
| K212591 | Disposable Surgical Gown | Suzhou Janee Medical Technology Co., Ltd. | 2022-01-11 | Traditional | PDF ↗ |
| K210355 | Surgical Gown, Model: surgical gown-hp-3 | Weihai Dishang Medical Technology Co., Ltd. | 2021-12-16 | Traditional | PDF ↗ |
| K212861 | Surgical Gown, Reinforced Surgical Gown | Wuhan Zonsen Medical Products Co., Ltd. | 2021-12-15 | Traditional | PDF ↗ |
| K212869 | Disposable Surgical Gown, Disposable Reinforced Surgical Gown | Fugou County Shenxiang Manufacturing Co., Ltd. | 2021-12-13 | Traditional | PDF ↗ |
| K212925 | Disposable Surgical Gown | Henan Robestain Medical Products Co., Ltd. | 2021-12-13 | Traditional | PDF ↗ |
| K203539 | Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) | Unicoglobal, Inc. | 2021-12-10 | Traditional | PDF ↗ |
| K211765 | Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown | Cardinal Health, LLC | 2021-11-23 | Traditional | PDF ↗ |
| K211509 | Surgical Gown | Hubei Wanli Protective Products Co., Ltd. | 2021-10-24 | Traditional | PDF ↗ |
| K211809 | Surgical Gown | Wuhan Dymex Healthcare Co., Ltd. | 2021-10-18 | Traditional | PDF ↗ |
| K211077 | Surgical Gown | Wujiang Tutaike Textiles & Finishing Co., Ltd. | 2021-10-07 | Traditional | PDF ↗ |
| K202532 | Disposable Surgical Gowns | Anhui Medpurest Medical Technology Co.,Ltd | 2021-08-21 | Traditional | PDF ↗ |
| K210510 | Disposable Surgical Gown | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-08-12 | Traditional | PDF ↗ |
| K210143 | Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) | Foshan Nanhai Plus Medical Co, Ltd. | 2021-07-22 | Traditional | PDF ↗ |
| K210688 | AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown | O&M Halyard, Inc. | 2021-07-21 | Abbreviated | PDF ↗ |
| K210215 | Surgical Gowns | Jiangsu Province Jianerkang Medical Dressing Co., Ltd. | 2021-07-07 | Traditional | PDF ↗ |
| K211422 | Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown | Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. | 2021-07-02 | Traditional | PDF ↗ |
| K202447 | Medline Orbis Surgical Gown | Medline Industries, Inc. | 2021-04-02 | Traditional | PDF ↗ |
| K202844 | Medical Surgical Gowns | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2021-01-06 | Traditional | PDF ↗ |
| K202706 | Surgical Gown (Sterile), Surgical Gown (Non-sterile) | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2020-12-31 | Traditional | PDF ↗ |
| K200977 | Modular Toga | Operating Room Innovations, Inc. | 2020-08-05 | Traditional | PDF ↗ |
| K200824 | Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown | Cardinal Health200, LLC | 2020-07-29 | Traditional | PDF ↗ |
| K192560 | Surgical Gown | Shandong Kangli Medical Equipment Technology Co., Ltd. | 2020-05-22 | Traditional | PDF ↗ |
| K192290 | 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown | Xuchang Zhengde Environstar Medical Products Co., Ltd. | 2020-04-30 | Traditional | PDF ↗ |
| K193327 | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve | Cardinal Health200, LLC | 2020-03-20 | Traditional | PDF ↗ |
| K200522 | AERO CHROME* Breathable Performance Surgical Gowns | O&M Halyard, Inc. | 2020-03-16 | Abbreviated | PDF ↗ |
| K192362 | Aero Blue Performance Surgical Gowns | O&M Halyard, Inc. | 2019-12-13 | Abbreviated | PDF ↗ |
| K192194 | TotalShield II Surgical Helmet System | Zimmer Surgical, Inc. | 2019-10-15 | Special | PDF ↗ |
| K190950 | 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) | Medline Industries, Inc. | 2019-07-04 | Traditional | PDF ↗ |
| K182172 | Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) | Medline Industries, Inc. | 2019-04-24 | Traditional | PDF ↗ |
| K173847 | Disposable Ultra Reinforced Surgical Gown | Xiantao Rayxin Medical Products Co., Ltd. | 2019-01-16 | Traditional | PDF ↗ |
| K172987 | Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) | Gmax Industries, Inc. | 2018-07-13 | Traditional | PDF ↗ |
| K172954 | Medline Prevention CoolZone Gown | Medline Industries, Inc. | 2018-06-15 | Traditional | PDF ↗ |
| K172445 | RoyalGuard Surgical Gown, i600, Breathable | Gri Medical & Electrical Technology Co., Ltd. | 2017-12-08 | Traditional | PDF ↗ |
| K170762 | Cardinal Health Non-Reinforced Surgical Gown | Cardinal Health200, LLC | 2017-06-09 | Traditional | PDF ↗ |
| K162930 | Aero Chrome* Select Breathable Performance Surgical Gowns | Halyard Health, Inc. | 2017-04-21 | Traditional | PDF ↗ |
| K163191 | ComfortGuard Surgical Gown, i600, Film Reinforced | Gri Medical & Electrical Technology Co., Ltd. | 2017-02-27 | Traditional | PDF ↗ |
| K162442 | ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 | Gri Medical & Electrical Technology Co., Ltd. | 2016-12-12 | Traditional | PDF ↗ |
| K150598 | Blockade Surgical Gown | Medline Industries, Inc. | 2016-04-28 | Traditional | PDF ↗ |
| K153255 | Aero Chrome* Breathable Performance Surgical Gown | Halyard Health, Inc. | 2016-04-13 | Traditional | PDF ↗ |
| K133075 | Plus Surgical Gowns (EO Sterilized), PMGB-XXX | Foshan Nanhai Plus Medical Co, Ltd. | 2015-06-24 | Traditional | PDF ↗ |
| K150151 | SmartGownTM surgical gown | Cardinal Health 200, Inc. | 2015-05-21 | Traditional | PDF ↗ |
| K141467 | SURGICAL GOWN | Xuchang Zhengde Environstar Medical Products Co.,L | 2015-03-05 | Traditional | PDF ↗ |
| K141606 | SURGICAL GOWN | Cobes Industries Co., Ltd. | 2014-11-17 | Traditional | PDF ↗ |
| K142166 | TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES | Zimmer, Inc. | 2014-08-28 | Special | PDF ↗ |
| K141095 | STRYKER STERI-SHIELD FLYTE HYBRID TOGAS | Stryker Corporation | 2014-08-26 | Special | PDF ↗ |
| K140539 | AERO BLUE PERFORMANCE SURGICAL GOWN | Kimberly-Clark Corporation | 2014-06-09 | Abbreviated | PDF ↗ |
| K121664 | T4/T5 HYTREL TOGAS | Stryker Corporation | 2014-03-10 | Traditional | PDF ↗ |
Product code FYA · Class II · General, Plastic Surgery. Data: openFDA.