510(k) Report

Devices descending from K030364

26 later devices reach Deroyal Gowns, Sterile, Non-Sterile through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052550Imc Surgical GownsIntl. Medsurg Connection, Inc.200525—
+2K102692SMS Gowns (Reinforced and Reinforced with Guider), Spunlace Gowns (Regular, Regular with…Hangzhou Jincheng Medical Supplier Manufacture Co.20110—
+2K100971Atek Surgical GownsHangzhou Atek Medical & Textile Co., Ltd.201021—
+2K070431Welmed, Inc. Surgical GownsWelmed, Inc.20072—
+3K120192Disposable Surgical GownsWeihai Hongyu Nonwoven Fabric Products Co., Ltd.2012201
+3K082479Sklar Surgical GownSklar Corp.20090—
+4K172987Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)Gmax Industries, Inc.201819—
+5K213893Comfort Gown, Safewear GownXuchang Zhengde Environstar Medical Products Co., Ltd.20220—
+5K211060Disposable Surgical Gown Rk-3011CXiantao Rhycom Non-Woven Products Co., Ltd.20220—
+5K211809Surgical GownWuhan Dymex Healthcare Co., Ltd.20211—
+5K211422Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced…Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.202111—
+5K202844Medical Surgical GownsBeijing Biosis Healing Biolog Ical Technology Co., Ltd.20212—
+6K233571GCI Surgical GownGeorge Courey, Inc.20240—
+6K221977Disposable Surgical Gown (G4003)Xiantao Topmed Nonwoven Protective Products Co., Ltd.20220—
+6K220092YADU Surgical GownsHenan Yadu Industrial Co., Ltd.20220—
+6K22181935g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS…Winner Medical Co., Ltd.20220—
+6K202845Bodygard SFS Surgical Gown Level 3Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi20220—
+6K212861Surgical Gown, Reinforced Surgical GownWuhan Zonsen Medical Products Co., Ltd.20212—
+6K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd.20213—
+6K212925Disposable Surgical GownHenan Robestain Medical Products Co., Ltd.20210—
+6K211077Surgical GownWujiang Tutaike Textiles & Finishing Co., Ltd.20210—
+7K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…Hubei Xinxin Non-Woven Co., Ltd.20260—
+7K231510Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)Xiantao Zhibo Non-Woven Products Co., Ltd.20231—
+7K222456High Protection Surgical Gown3A Medical Products Co., Ltd.20230—
+7K221139Bodygard SFS Surgical Gown Level 4Feliks Plastik Laminasyon VE Ambalaj Malzemeleri20220—
+8K233183Surgical Gown (40083)Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.20240—