510(k) Report

Devices descending from K211827

6 later devices reach Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213601Surgical MaskWuhan Zonsen Medical Products Co., Ltd.20220—
+1K221976Surgical Face Mask (Non-sterile)Xiantao Junhui Plastic Products Co., Ltd.20220—
+1K220824Medical Surgical Mask (Planar type)Hunan Chopard Medical Devices Co., Ltd.20220—
+1K213806Disposable Medical Face MaskXiantao Zhibo Nonwoven Products Co., Ltd.20222—
+2K223055Disposable Medical Face MaskXiantao Zhuobo Industrial Co., Ltd.20220—
+2K222697Disposable Medical Face Mask (DF3-001)Wellmed Dental Medical Supply Co., Ltd.20220—