510(k) Report

Devices descending from K043585

20 later devices reach Medline Surgical Gowns through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172987Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)Gmax Industries, Inc.201819—
+2K213893Comfort Gown, Safewear GownXuchang Zhengde Environstar Medical Products Co., Ltd.20220—
+2K211060Disposable Surgical Gown Rk-3011CXiantao Rhycom Non-Woven Products Co., Ltd.20220—
+2K211809Surgical GownWuhan Dymex Healthcare Co., Ltd.20211—
+2K211422Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced…Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.202111—
+2K202844Medical Surgical GownsBeijing Biosis Healing Biolog Ical Technology Co., Ltd.20212—
+3K233571GCI Surgical GownGeorge Courey, Inc.20240—
+3K221977Disposable Surgical Gown (G4003)Xiantao Topmed Nonwoven Protective Products Co., Ltd.20220—
+3K220092YADU Surgical GownsHenan Yadu Industrial Co., Ltd.20220—
+3K22181935g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS…Winner Medical Co., Ltd.20220—
+3K202845Bodygard SFS Surgical Gown Level 3Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi20220—
+3K212861Surgical Gown, Reinforced Surgical GownWuhan Zonsen Medical Products Co., Ltd.20212—
+3K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd.20213—
+3K212925Disposable Surgical GownHenan Robestain Medical Products Co., Ltd.20210—
+3K211077Surgical GownWujiang Tutaike Textiles & Finishing Co., Ltd.20210—
+4K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…Hubei Xinxin Non-Woven Co., Ltd.20260—
+4K231510Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)Xiantao Zhibo Non-Woven Products Co., Ltd.20231—
+4K222456High Protection Surgical Gown3A Medical Products Co., Ltd.20230—
+4K221139Bodygard SFS Surgical Gown Level 4Feliks Plastik Laminasyon VE Ambalaj Malzemeleri20220—
+5K233183Surgical Gown (40083)Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.20240—