510(k) Report

Devices descending from K952116

17 later devices reach Cover Gown through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160339Cardinal Health Isolation GownCardinal Health200, LLC2016162
+2K221027Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))Allmed Medical (Hubei) Protective Products Co., Ltd.20220—
+2K202310Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full BackWildcat Ppe, LLC20215—
+2K190306AMD Ritmed AssureWear VersaGownAmd Medicom, Inc.20206—
+2K171535Surgical Isolation GownJingzhou Haixin Green Cross Medical Products Co., Ltd.20181—
+3K230135Copioumed Chemotherapy Isolation GownCopioumed International, Inc.20230—
+3K210414CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with…Medtecs (Taiwan) Corp.20220—
+3K214116AAMI4 Isolation GownHubei Xinxin Non-Woven Co., Ltd.20220—
+3K220528Surgical Isolation Cover GownWuhan Dymex Healthcare Co., Ltd.20220—
+3K212357Surgical isolation gownWuhan Zonsen Medical Products Co., Ltd.20220—
+3K212633Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3…String King Lacrosse, LLC20210—
+3K210785Disposable Surgical GownsChongqing Litai Fashion Group Limited Company20213—
+3K203415Surgical Isolation GownYanbian Pacific Textile Co., Ltd.20211—
+4K223467Disposable Isolation GownNanning Tecbod Biological Technology Co., Ltd.20230—
+4K223304Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Technology Co., Ltd.20230—
+4K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd.20230—
+4K212422Disposable Surgical Isolation GownCrown Name Disposable Hygiene Products Fty., Ltd.20220—