510(k) Report

Devices descending from K182515

50 later devices reach Surgical Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K214035LAITEST Medical Face MaskR&R Medical Corporation, Ltd.20220—
+1K220532Disposable surgical maskXiamen Blue Star Enterprise Co., Ltd.20220—
+1K212944Disposable Surgical MaskHeilongjiang Yinjia Medical Equipment Co., Ltd.20210—
+1K212574Surgical Face MaskXiantao Deming Healthcare Products Co., Ltd.20210—
+1K202794Surgical face mask: F-Y1-AJiande Chaomei Daily Chemicals Co., Ltd.20210—
+1K202842Medical surgical maskHenan Huibo Medical Co., Ltd.20210—
+1K212344Surgical MaskXiantao Dingcheng Non-Woven Product Co., Ltd.20211—
+1K212575Surgical Face MaskHubei Huanfu Plastic Products Co., Ltd.20210—
+1K202676Disposable Medical Face MaskZhejiang Senhong Medical&Instrument Co., Ltd.20210—
+1K211425Private Stock Labs Surgical Face MaskJ.K. Private Stock, Inc.20210—
+1K211899Surgical Face MaskHubei Yi-Ya Protective Products Co., Ltd.20211—
+1K211296Surgical face maskSunsmed Protective Products, Ltd.20210—
+1K202746Surgical maskNingbo Jingeao Electronics, Inc.20210—
+1K211451Disposable Surgical Mask (non sterile)Qinhuangdao Taizhi Medical Technology Co., Ltd.20210—
+1K202745Disposable medical face maskNingbo Jingeao Electronics, Inc.20211—
+1K211897Surgical Face MaskZhejiang Hongyu Medicali Commodity Co., Ltd.20211—
+1K210870MEO Med Disposable Medical Face MaskFujian Meo Medical Technology Limited20210—
+1K203534Surgical face mask (Model: Flat Ear Loop/CN102)Crown Name Disposable Hygiene Products Fty., Ltd.20210—
+1K210761Velguard Surgical Face MaskEsstee Exports Health Care Division20210—
+1K202714Medical Face MaskChongqing Chaoke Industry Development Co., Ltd.20210—
+1K210015Surgical Face MaskSample King Manufacturing, Ltd.20210—
+1K210433Surgical Face Mask (Ear loops and Tie-on)Wuhan Dymex Healthcare Co., Ltd.20215—
+1K203190Surgical Face MaskRfx+Care Manufactoring Co., Ltd.20210—
+1K202647Surgical MaskNingbo Green Textile Co., Ltd.20210—
+1K202650Medical disposable face mask non sterileGuangdong Zhong Ling Industrial Group Co., Ltd.20210—
+1K201698Medical Surgical MaskHangzhou Mycode Bio-Medicine Co., Ltd.20210—
+1K201852Surgical Mask-Model Number: Ear Loop, Flat-PleatedHuizhou Foryou Medical Devices Co., Ltd.20210—
+1K201545Surgical Face MaskAmphastar Nanjing Pharmaceuticals, Inc.20210—
+1K202595Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face MaskPremier Guard USA, LLC20213—
+1K202314Procedure face mask (Model: KKF-2A)Han Zhaoqing Sporting Goods Company Limited20210—
+1K201625Disposable Medical Surgical MaskTianjin Saiyuan Technology Co., Ltd.20210—
+1K201380Livocare Surgical MaskAndon Health Co, Ltd.20200—
+1K202463Disposable Surgical MaskUnisources Group, LLC20204—
+1K201517Plain Surgical MaskAok Tooling Limited20200—
+2K232112R&G Surgical MaskR&G Seguridad E Higiene Industrial S.A.C.20240—
+2K232359Surgical face maskKingstar Medical (Xianning) Co., Ltd.20230—
+2K2316183 Layer Surgical Mask (134252531)Original Mattress Factory, Inc.20230—
+2K230395Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)Durio Ppe Sdn Bhd20230—
+2K221038Disposable Medical MasksHantech Medical Device Co., Ltd.20220—
+2K221196Disposable Medical Face Mask (ear loop)Xiantao Topmed Nonwoven Protective Products Co., Ltd.20221—
+2K220378Sparta 3-Ply Surgical Disposable Face MaskSparta East, LLC20220—
+2K220550Disposable Surgical Face Mask (M663BE, M663BT)Makrite Industries, Inc.20220—
+2K220512Disposable Surgical Face Mask (M01, M02)Fomed Industries, Inc.20220—
+2K213970D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 PlyDanameco Medical Joint Stock Corporation20220—
+2K212046Impertech Surgical Face MaskImpertech Industries, Ltd.20210—
+2K211165Medical Face Masks, Model Name:MY020003Huizhou Jie Bai Purification Co., Ltd.20210—
+2K210348Disposable Medical Surgical MaskWeihai Dishang Medical Technology Co., Ltd.20210—
+2K211861TAIJI Professional Series Level 3 Surgical Face MaskTaiji Medical Supplies, Inc.20210—
+2K211249Altor Safety 3-Ply Surgical Mask (Model:62222)Altor Safety, LLC20210—
+3K232797HygenixShenzhen Hygenix Industrial Co., Ltd.20230—