510(k) Report

Devices descending from K200923

16 later devices reach Single-use Surgical Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221957Savewo ClassicMASKSavewo Limited20220—
+1K211827Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)Zhejiang Lanhine Medical Products, Ltd.20216—
+1K203418Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))Ningbo Ouhan Medical Device Co., Ltd.20210—
+1K211042Disposable Procedural Ear-loop Face MaskChangzhou Dsb Medical Co., Ltd.20210—
+1K210372Disposable Surgical MaskDongguan Shin YI Healthcare Products Factory20210—
+1K210218SURGICAL MASK, Model Name:C015Qingdao Hainuo Biological Engineering Co., Ltd.20211—
+1K210020Medical MaskZhende Medical Co., Ltd.20210—
+1K203801Disposable Surgical Face MaskAnhui Jiabao Protective Equipments Co., Ltd.20211—
+2K213601Surgical MaskWuhan Zonsen Medical Products Co., Ltd.20220—
+2K221976Surgical Face Mask (Non-sterile)Xiantao Junhui Plastic Products Co., Ltd.20220—
+2K220824Medical Surgical Mask (Planar type)Hunan Chopard Medical Devices Co., Ltd.20220—
+2K210422INTAI Surgical Mask (non-sterile)Intai Technology Corp.20220—
+2K213806Disposable Medical Face MaskXiantao Zhibo Nonwoven Products Co., Ltd.20222—
+2K213136CPL Surgical Face MaskControl Print Limited20210—
+3K223055Disposable Medical Face MaskXiantao Zhuobo Industrial Co., Ltd.20220—
+3K222697Disposable Medical Face Mask (DF3-001)Wellmed Dental Medical Supply Co., Ltd.20220—