510(k) Report

Devices descending from K211422

11 later devices reach Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233571GCI Surgical GownGeorge Courey, Inc.20240—
+1K220092YADU Surgical GownsHenan Yadu Industrial Co., Ltd.20220—
+1K22181935g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS…Winner Medical Co., Ltd.20220—
+1K212861Surgical Gown, Reinforced Surgical GownWuhan Zonsen Medical Products Co., Ltd.20212—
+1K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd.20213—
+1K212925Disposable Surgical GownHenan Robestain Medical Products Co., Ltd.20210—
+2K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…Hubei Xinxin Non-Woven Co., Ltd.20260—
+2K231510Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)Xiantao Zhibo Non-Woven Products Co., Ltd.20231—
+2K222456High Protection Surgical Gown3A Medical Products Co., Ltd.20230—
+2K221139Bodygard SFS Surgical Gown Level 4Feliks Plastik Laminasyon VE Ambalaj Malzemeleri20220—
+3K233183Surgical Gown (40083)Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.20240—