510(k) Report

Devices descending from K020593

20 later devices reach Convertors SMS Polyolefin Gown through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190950Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown…Medline Industries, Inc.201952
+1K170762Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC20171917
+2K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.20260—
+2K251860Copioumed AAMI 3 Surgical GownCopioumed International, Inc.20260—
+2K250564Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.20250—
+2K220435SEJONG Surgical Gown SoftSejong Healthcare Co., Ltd.20230—
+2K203548EndoArmor™ + Surgical GownBoston Scientific Corporation20220—
+2K212718Surgical gownsXiantao Dingcheng Non-Woven Product Co., Ltd.20220—
+2K212591Disposable Surgical GownSuzhou Janee Medical Technology Co., Ltd.20222—
+2K203539Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical…Unicoglobal, Inc.20210—
+2K211509Surgical GownHubei Wanli Protective Products Co., Ltd.20212—
+2K202532Disposable Surgical GownsAnhui Medpurest Medical Technology Co.,Ltd20210—
+2K210510Disposable Surgical GownShandong Zhushi Pharmaceutical Group Co., Ltd.20210—
+2K173847Disposable Ultra Reinforced Surgical GownXiantao Rayxin Medical Products Co., Ltd.20192—
+3K222999Surgical GownHubei Woozon Healthcare Co., Ltd.20231—
+3K223401Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd.20230—
+3K221717Disposable Surgical Gown UM-148Unimax Medical Products Co., Ltd.20220—
+3K214088Disposable Surgical GownWeihai Hongyu Nonwoven Fabric Products Co., Ltd.20221—
+4K242937Dream Medi Sterile Surgical Gown (SurgicalGownUL)Dae Myung Chemical Co., Ltd. (Vietnam)20250—
+4K222403Surgical GownGuangzhou Fuzelong Hygiene Material Co., Ltd.20230—