510(k) Report

Devices descending from K211509

2 later devices reach Surgical Gown through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222999Surgical GownHubei Woozon Healthcare Co., Ltd.20231—
+2K242937Dream Medi Sterile Surgical Gown (SurgicalGownUL)Dae Myung Chemical Co., Ltd. (Vietnam)20250—