ClearanceBrief
Panels › General, Plastic Surgery › Product code FYA · Class 2

Gown, Surgical

Regulation 878.4040

10510(k)s in 12 months (298 all time)
5recalls in 12 months (129 all time)
106recalls that name a 510(k)
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Top companies in FYA

Company510(k)sRecalls
Cardinal Health, LLC150
Stryker Instruments Div. of Stryker Corporation030
Medline Industries, Inc.164
Customed, Inc.117
Kimberly-Clark Corp.125
Standard Textile Co., Inc.140
Allegiance Healthcare Corp.80
The Sewing Source, Inc.80
The Buckeye Cellulose Corp.70
Baxter Healthcare Corp60
Decided510(k)Device and applicantCode
Aug 26, 2026K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMM
Principle & Will Co., Ltd., WS
FYA
Aug 7, 2026K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
Yadu Medical (Henan) Co., Ltd., CN
FYA
Jul 10, 2026K261949NYES Tuff Cuff L3 Disposable Gowns
New York Embroidery Studio
FYA
Jun 4, 2026K252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
New York Embroidery Studio (NYES)
FYA
May 12, 2026K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
Hindernis DE Mexico, S.A.P.I. DE C.V., MX
FYA
Apr 28, 2026K253243Cardinal Health™ Poly Reinforced Surgical Gown
Cardinal Health 200, LLC
FYA
Apr 20, 2026K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical
Hubei Xinxin Non-Woven Co., Ltd., CN
FYA
Feb 26, 2026K251860Copioumed AAMI 3 Surgical Gown
Copioumed International, Inc., TW
FYA
Feb 4, 2026K252301Henan Yadu Level 4 Surgical Gowns (Reinforced)
Yadu Medical (Henan) Co., Ltd., CN
FYA
Dec 3, 2025K250564Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
Yadu Medical (Henan) Co., Ltd., CN
FYA
May 30, 2025K243522ViVi® Toga Premium
Thi Total Healthcare Innovation GmbH, AT
FYA
May 5, 2025K242937Dream Medi Sterile Surgical Gown (SurgicalGownUL)
Dae Myung Chemical Co., Ltd. (Vietnam), VN
FYA
Feb 26, 2025K242844Medline Level 4 Surgical Gown with Breathable Sleeves
Medline Industries, LP
FYA
Oct 16, 2024K241272Stryker Steri-Shield 8 Surgical Hoods and Togas
Stryker Instruments
FYA
Sep 10, 2024K241214ProPel SG3™ Surgical Gown
Standard Textile Co., Inc.
FYA
Aug 2, 2024K233571GCI Surgical Gown
George Courey, Inc., CA
FYA
Mar 29, 2024K233068Disposable Surgical Gown
Nanning Tecbod Biological Technology Co., Ltd., CN
FYA
Feb 1, 2024K233183Surgical Gown (40083)
Ammex-Weida (Hubei) Health and Safety Products Co., Ltd., CN
FYA
Oct 12, 2023K230707Skypro, Surgical Gown 6021
Skypro Medical Supplies Company, CN
FYA
Aug 23, 2023K230610Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgica
Dongguan Shin YI Healthcare Products Factory, CN
FYA
Aug 22, 2023K231510Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)
Xiantao Zhibo Non-Woven Products Co., Ltd., CN
FYA
Aug 16, 2023K230577Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi, TR
FYA
Jul 27, 2023K230838Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets
Cardinal Health200, LLC
FYA
Jun 16, 2023K222999Surgical Gown
Hubei Woozon Healthcare Co., Ltd., CN
FYA
Mar 12, 2023K222456High Protection Surgical Gown
3A Medical Products Co., Ltd., CN
FYA
Mar 7, 2023K223401Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)
Xiamen Probtain Medical Techology Co., Ltd., CN
FYA
Feb 23, 2023K221559Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3
Stringking
FYA
Feb 16, 2023K213844Surgical Gown
Bayteks Teknik Tekstil San. VE Tic. A.S., TR
FYA
Feb 10, 2023K220435SEJONG Surgical Gown Soft
Sejong Healthcare Co., Ltd., KR
FYA
Jan 26, 2023K222403Surgical Gown
Guangzhou Fuzelong Hygiene Material Co., Ltd., CN
FYA
Dec 21, 2022K213893Comfort Gown, Safewear Gown
Xuchang Zhengde Environstar Medical Products Co., Ltd., CN
FYA
Nov 16, 2022K212812Surgical Gown
Xianning Marveldas Protective Articles Co., Ltd., CN
FYA
Nov 14, 2022K222480Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)
Foshan Nanhai Plus Medical Co, Ltd., CN
FYA
Nov 10, 2022K221139Bodygard SFS Surgical Gown Level 4
Feliks Plastik Laminasyon VE Ambalaj Malzemeleri, TR
FYA
Oct 28, 2022K211060Disposable Surgical Gown Rk-3011C
Xiantao Rhycom Non-Woven Products Co., Ltd., CN
FYA
Oct 20, 2022K221977Disposable Surgical Gown (G4003)
Xiantao Topmed Nonwoven Protective Products Co., Ltd., CN
FYA
Oct 7, 2022K220092YADU Surgical Gowns
Henan Yadu Industrial Co., Ltd., CN
FYA
Sep 29, 2022K221637Surgical Gown (Sterile); Surgical Gown (Non-sterile)
Allmed Medical (Hubei) Protective Products Co., Ltd., CN
FYA
Sep 20, 2022K221717Disposable Surgical Gown UM-148
Unimax Medical Products Co., Ltd., CN
FYA
Sep 19, 2022K22181935g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS S
Winner Medical Co., Ltd., CN
FYA
Jul 22, 2022K211399Sterile Level 3 Surgical Gown
Barco Tekstil Sanayi VE Ticaret A.S., TR
FYA
Jun 3, 2022K220665Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile
Excellent Medical Technology Group Co., Ltd., CN
FYA
May 18, 2022K220333Medline Orbis LVL 3 Surgical Gown
Medline Industries, LP
FYA
May 11, 2022K213177Plus Medical Cover Gown
Foshan Nanhai Plus Medical Co, Ltd., CN
FYA
May 6, 2022K214108Medline Orbis Chemo Surgical Gown
Medline Industries, LP
FYA
May 4, 2022K211036Plus Medical Chemotherapy Gown
Foshan Nanhai Plus Medical Co, Ltd., CN
FYA
Apr 12, 2022K214088Disposable Surgical Gown
Weihai Hongyu Nonwoven Fabric Products Co., Ltd., CN
FYA
Mar 18, 2022K203237Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical G
Dukal Corporation
FYA
Mar 11, 2022K201351Maxima Surgical Gown
Elevate Textiles
FYA
Mar 4, 2022K213703Surgical Gown
Wujiang Tutaike Textiles & Finishing Co., Ltd., CN
FYA

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