510(k) Report

Devices descending from K190306

6 later devices reach AMD Ritmed AssureWear VersaGown through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230135Copioumed Chemotherapy Isolation GownCopioumed International, Inc.20230—
+1K210414CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with…Medtecs (Taiwan) Corp.20220—
+1K214116AAMI4 Isolation GownHubei Xinxin Non-Woven Co., Ltd.20220—
+1K212357Surgical isolation gownWuhan Zonsen Medical Products Co., Ltd.20220—
+1K203415Surgical Isolation GownYanbian Pacific Textile Co., Ltd.20211—
+2K212422Disposable Surgical Isolation GownCrown Name Disposable Hygiene Products Fty., Ltd.20220—