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
Feb 24, 2022K202845Bodygard SFS Surgical Gown Level 3
Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi, TR
FYA
Feb 21, 2022K203548EndoArmor™ + Surgical Gown
Boston Scientific Corporation
FYA
Jan 12, 2022K212718Surgical gowns
Xiantao Dingcheng Non-Woven Product Co., Ltd., CN
FYA
Jan 11, 2022K212591Disposable Surgical Gown
Suzhou Janee Medical Technology Co., Ltd., CN
FYA
Dec 16, 2021K210355Surgical Gown, Model: surgical gown-hp-3
Weihai Dishang Medical Technology Co., Ltd., CN
FYA
Dec 15, 2021K212861Surgical Gown, Reinforced Surgical Gown
Wuhan Zonsen Medical Products Co., Ltd., CN
FYA
Dec 13, 2021K212925Disposable Surgical Gown
Henan Robestain Medical Products Co., Ltd., CN
FYA
Dec 13, 2021K212869Disposable Surgical Gown, Disposable Reinforced Surgical Gown
Fugou County Shenxiang Manufacturing Co., Ltd., CN
FYA
Dec 10, 2021K203539Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)
Unicoglobal, Inc., KR
FYA
Nov 23, 2021K211765Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown
Cardinal Health, LLC
FYA
Oct 24, 2021K211509Surgical Gown
Hubei Wanli Protective Products Co., Ltd., CN
FYA
Oct 18, 2021K211809Surgical Gown
Wuhan Dymex Healthcare Co., Ltd., CN
FYA
Oct 7, 2021K211077Surgical Gown
Wujiang Tutaike Textiles & Finishing Co., Ltd., CN
FYA
Aug 21, 2021K202532Disposable Surgical Gowns
Anhui Medpurest Medical Technology Co.,Ltd, CN
FYA
Aug 12, 2021K210510Disposable Surgical Gown
Shandong Zhushi Pharmaceutical Group Co., Ltd., CN
FYA
Jul 22, 2021K210143Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)
Foshan Nanhai Plus Medical Co, Ltd., CN
FYA
Jul 21, 2021K210688AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown
O&M Halyard, Inc.
FYA
Jul 7, 2021K210215Surgical Gowns
Jiangsu Province Jianerkang Medical Dressing Co., Ltd., CN
FYA
Jul 2, 2021K211422Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown
Jiangsu Medplus Non-Woven Manufacturer Co., Ltd., CN
FYA
Apr 2, 2021K202447Medline Orbis Surgical Gown
Medline Industries, Inc.
FYA
Jan 6, 2021K202844Medical Surgical Gowns
Beijing Biosis Healing Biolog Ical Technology Co., Ltd., CN
FYA
Dec 31, 2020K202706Surgical Gown (Sterile), Surgical Gown (Non-sterile)
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd., CN
FYA
Aug 5, 2020K200977Modular Toga
Operating Room Innovations, Inc.
FYA
Jul 29, 2020K200824Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown
Cardinal Health200, LLC
FYA
May 22, 2020K192560Surgical Gown
Shandong Kangli Medical Equipment Technology Co., Ltd., CN
FYA
Apr 30, 2020K19229050g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgic
Xuchang Zhengde Environstar Medical Products Co., Ltd., CN
FYA
Mar 20, 2020K193327Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Card
Cardinal Health200, LLC
FYA
Mar 16, 2020K200522AERO CHROME* Breathable Performance Surgical Gowns
O&M Halyard, Inc.
FYA
Dec 13, 2019K192362Aero Blue Performance Surgical Gowns
O&M Halyard, Inc.
FYA
Oct 15, 2019K192194TotalShield II Surgical Helmet System
Zimmer Surgical, Inc.
FYA
Jul 4, 2019K190950Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medli
Medline Industries, Inc.
FYA
Apr 24, 2019K182172Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)
Medline Industries, Inc.
FYA
Jan 16, 2019K173847Disposable Ultra Reinforced Surgical Gown
Xiantao Rayxin Medical Products Co., Ltd., CN
FYA
Jul 13, 2018K172987Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)
Gmax Industries, Inc.
FYA
Jun 15, 2018K172954Medline Prevention CoolZone Gown
Medline Industries, Inc.
FYA
Dec 8, 2017K172445RoyalGuard Surgical Gown, i600, Breathable
Gri Medical & Electrical Technology Co., Ltd., CN
FYA
Jun 9, 2017K170762Cardinal Health Non-Reinforced Surgical Gown
Cardinal Health200, LLC
FYA
Apr 21, 2017K162930Aero Chrome* Select Breathable Performance Surgical Gowns
Halyard Health, Inc.
FYA
Feb 27, 2017K163191ComfortGuard Surgical Gown, i600, Film Reinforced
Gri Medical & Electrical Technology Co., Ltd., CN
FYA
Dec 12, 2016K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500
Gri Medical & Electrical Technology Co., Ltd., CN
FYA
Apr 28, 2016K150598Blockade Surgical Gown
Medline Industries, Inc.
FYA
Apr 13, 2016K153255Aero Chrome* Breathable Performance Surgical Gown
Halyard Health, Inc.
FYA
Jun 24, 2015K133075Plus Surgical Gowns (EO Sterilized), PMGB-XXX
Foshan Nanhai Plus Medical Co, Ltd.
FYA
May 21, 2015K150151SmartGownTM surgical gown
Cardinal Health 200, Inc.
FYA
Mar 5, 2015K141467SURGICAL GOWN
Xuchang Zhengde Environstar Medical Products Co.,L, CN
FYA
Nov 17, 2014K141606SURGICAL GOWN
Cobes Industries Co., Ltd., CN
FYA
Aug 28, 2014K142166TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES
Zimmer, Inc.
FYA
Aug 26, 2014K141095STRYKER STERI-SHIELD FLYTE HYBRID TOGAS
Stryker Corporation
FYA
Jun 9, 2014K140539AERO BLUE PERFORMANCE SURGICAL GOWN
Kimberly-Clark Corporation
FYA
Mar 10, 2014K121664T4/T5 HYTREL TOGAS
Stryker Corporation
FYA

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