510(k) Report

Devices descending from K080795

18 later devices reach Ultra Surgical Gown & Fluid Barrier Surgical Gown through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182172Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline…Medline Industries, Inc.201921
+1K163191ComfortGuard Surgical Gown, i600, Film ReinforcedGri Medical & Electrical Technology Co., Ltd.20171—
+1K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500Gri Medical & Electrical Technology Co., Ltd.20161—
+1K1014683M Basic Disposable Surgical Gown, 3M HP Disposable Surgical Gown, 3M Reinforced…3M Company Corp20111—
+1K102652Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced…Gri Medical & Electronic Technology Co., Ltd.20118—
+2K261811PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested…PRIMED Medical Products, Inc.20260—
+2K252301Henan Yadu Level 4 Surgical Gowns (Reinforced)Yadu Medical (Henan) Co., Ltd.20260—
+2K242844Medline Level 4 Surgical Gown with Breathable SleevesMedline Industries, LP20250—
+2K230707Skypro, Surgical Gown 6021Skypro Medical Supplies Company20230—
+2K172445RoyalGuard Surgical Gown, i600, BreathableGri Medical & Electrical Technology Co., Ltd.20170—
+2K141467Surgical GownXuchang Zhengde Environstar Medical Products Co.,L20151—
+2K121152Surgical Gown, SMSJiangsu Guangda Medical Material, Co., Ltd.20127—
+3K212812Surgical GownXianning Marveldas Protective Articles Co., Ltd.20220—
+3K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd.20213—
+3K210215Surgical GownsJiangsu Province Jianerkang Medical Dressing Co., Ltd.20210—
+4K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…Hubei Xinxin Non-Woven Co., Ltd.20260—
+4K222456High Protection Surgical Gown3A Medical Products Co., Ltd.20230—
+4K221139Bodygard SFS Surgical Gown Level 4Feliks Plastik Laminasyon VE Ambalaj Malzemeleri20220—