510(k) Report

Devices descending from K910110

331 later devices reach Triple Layer Fluid-Resistant Molded Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K202594Medical Surgical Masks-Non SterileShandong T&F Nonwoven Co., Ltd.20212—
+7K202719Disposable Medical Face MasksJiangxi Sanxin Medtec Co., Ltd.20212—
+7K202211Disposable Medical Surgical Face MasksGuangdong Kaidi Garments Co.,Ltd20203—
+7K201629Medical Face MaskShandong Shengquan New Material Co., Ltd.20203—
+7K202277Surgical Face MaskJiangxi 3l Medical Products Group Co., Ltd.20200—
+7K201691Single-Use Surgical Mask With Ear LoopQiqihar Hengxin Medical Supplies, Ltd.20203—
+7K202354Surgical Mask-Model Number CW01Hunan Heng Chang Pharmaceutical Co., Ltd.20201—
+7K200923Single-use Surgical MaskByd Precision Manufacturer Co., Ltd.202016—
+7K182515Surgical Face MaskWuhan Dymex Healthcare Co., Ltd.201950—
+7K182514Surgical Face MaskXiantao Zhibo Non-Woven Products Co., Ltd.201929—
+8K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.20260—
+8K240916Surgical Face Mask (Tie on/ Ear loops)Xiantao Daoqi Plastic Co., Ltd.20240—
+8K231719Medical Surgical MaskAzur Medical Company, Inc.20240—
+8K221209PRECISION ECO Compostable / Plant Based Procedural Mask with EarloopsPadm Medical, Inc.20230—
+8K223686Medical Protective MasksQinhuangdao Taizhi Medical Technology Co., Ltd.20230—
+8K214035LAITEST Medical Face MaskR&R Medical Corporation, Ltd.20220—
+8K221957Savewo ClassicMASKSavewo Limited20220—
+8K203078CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AWHuizhou Tianchang Industrial Co., Ltd.20220—
+8K220378Sparta 3-Ply Surgical Disposable Face MaskSparta East, LLC20220—
+8K220597Disposable Surgical Face Mask (FM-34EE,FM-44EE)Qingdao Bestex Rubber & Plastic Products Co., Ltd.20221—
+8K220532Disposable surgical maskXiamen Blue Star Enterprise Co., Ltd.20220—
+8K220487Disposable Medical Face MaskHubei Mediunion Medical Products Co., Ltd.20220—
+8K2206373 Ply Medical Grade Single Use Procedural Disposable Face MaskKdi Med Supply20220—
+8K213347ADI Medical Surgical Face MaskAsia Dynamics Inc., D/B/A Adi Medical20220—
+8K212913Surgical Face MaskJiangxi Ganlong Pharmaceutical Co., Ltd.20220—
+8K212299Medical Surgical MaskWepon Medical Technology Co., Ltd.20220—
+8K213136CPL Surgical Face MaskControl Print Limited20210—
+8K212059Surgical Face MaskZhongshan Saifute Labor Protective Articles Co., Ltd.20210—
+8K210102Topwide Surgical Face MaskTopwide (Hubei) Medical Products Manufacturer20210—
+8K212944Disposable Surgical MaskHeilongjiang Yinjia Medical Equipment Co., Ltd.20210—
+8K212574Surgical Face MaskXiantao Deming Healthcare Products Co., Ltd.20210—
+8K202794Surgical face mask: F-Y1-AJiande Chaomei Daily Chemicals Co., Ltd.20210—
+8K212235Surgical Face MaskShanghai Yunqing Industrial Co., Ltd.20210—
+8K212807Surgical MasksWeihai Hongyu Nonwoven Fabric Products Co., Ltd.20210—
+8K212740Puravita Medical Fold Flat Surgical MaskPuravita M, LLC20210—
+8K202842Medical surgical maskHenan Huibo Medical Co., Ltd.20210—
+8K211956039 Surgical Face MaskAok Tooling Limited20211—
+8K210042Disposable Surgical MaskSuzhou Letian Protective Products Co., Ltd.20210—
+8K212344Surgical MaskXiantao Dingcheng Non-Woven Product Co., Ltd.20211—
+8K212575Surgical Face MaskHubei Huanfu Plastic Products Co., Ltd.20210—
+8K202676Disposable Medical Face MaskZhejiang Senhong Medical&Instrument Co., Ltd.20210—
+8K211425Private Stock Labs Surgical Face MaskJ.K. Private Stock, Inc.20210—
+8K211899Surgical Face MaskHubei Yi-Ya Protective Products Co., Ltd.20211—
+8K211827Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)Zhejiang Lanhine Medical Products, Ltd.20216—
+8K211097Banyan USA Surgical Mask Level 3Banyan USA, LLC20210—
+8K203418Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))Ningbo Ouhan Medical Device Co., Ltd.20210—
+8K203455Disposable Medical MaskFujian Kang Chen Daily Necessities Co., Ltd.20210—
+8K211296Surgical face maskSunsmed Protective Products, Ltd.20210—
+8K202746Surgical maskNingbo Jingeao Electronics, Inc.20210—
+8K211451Disposable Surgical Mask (non sterile)Qinhuangdao Taizhi Medical Technology Co., Ltd.20210—
+8K202745Disposable medical face maskNingbo Jingeao Electronics, Inc.20211—
+8K211552Surgical maskShandong Shengquan New Materials Co., Ltd.20212—
+8K210643Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd.20210—
+8K211897Surgical Face MaskZhejiang Hongyu Medicali Commodity Co., Ltd.20211—
+8K210870MEO Med Disposable Medical Face MaskFujian Meo Medical Technology Limited20210—
+8K210856Purism Disposable Surgical MaskChuzhou Daddy'S Choice Science and Technology Co., Ltd.20210—
+8K211497Surgical MaskHoneywell Safety Products20210—
+8K211984MASC Surgical MaskMid-America Safety Corp.20210—
+8K203534Surgical face mask (Model: Flat Ear Loop/CN102)Crown Name Disposable Hygiene Products Fty., Ltd.20210—
+8K210761Velguard Surgical Face MaskEsstee Exports Health Care Division20210—
+8K211042Disposable Procedural Ear-loop Face MaskChangzhou Dsb Medical Co., Ltd.20210—
+8K203591Single-use Medical Face MaskConod Medical Co., Limited20211—
+8K202714Medical Face MaskChongqing Chaoke Industry Development Co., Ltd.20210—
+8K210015Surgical Face MaskSample King Manufacturing, Ltd.20210—
+8K210433Surgical Face Mask (Ear loops and Tie-on)Wuhan Dymex Healthcare Co., Ltd.20215—
+8K210372Disposable Surgical MaskDongguan Shin YI Healthcare Products Factory20210—
+8K203190Surgical Face MaskRfx+Care Manufactoring Co., Ltd.20210—
+8K210815Disposable Face MaskBiobase Scientific (Shandong) Co., Ltd.20210—
+8K210218SURGICAL MASK, Model Name:C015Qingdao Hainuo Biological Engineering Co., Ltd.20211—
+8K210020Medical MaskZhende Medical Co., Ltd.20210—
+8K202647Surgical MaskNingbo Green Textile Co., Ltd.20210—
+8K210007Face MaskJinhua Jingdi Medical Supplies Co., Ltd.20211—
+8K202650Medical disposable face mask non sterileGuangdong Zhong Ling Industrial Group Co., Ltd.20210—
+8K201698Medical Surgical MaskHangzhou Mycode Bio-Medicine Co., Ltd.20210—
+8K201852Surgical Mask-Model Number: Ear Loop, Flat-PleatedHuizhou Foryou Medical Devices Co., Ltd.20210—
+8K203426Surgical Face Mask (non-sterile)Nantong Taiweishi Medical Technology Co., Ltd.202113—
+8K201545Surgical Face MaskAmphastar Nanjing Pharmaceuticals, Inc.20210—
+8K210063Freudenberg Surgical MaskFreudenberg Performance Materials LP20212—
+8K202511Disposable Medical Surgical MaskImprove Medical (Hunan) Co., Ltd.20214—
+8K202595Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face MaskPremier Guard USA, LLC20213—
+8K202314Procedure face mask (Model: KKF-2A)Han Zhaoqing Sporting Goods Company Limited20210—
+8K201625Disposable Medical Surgical MaskTianjin Saiyuan Technology Co., Ltd.20210—
+8K201893Disposable Surgical MaskXiamen Probtain Medical Techology Co., Ltd.20200—
+8K201380Livocare Surgical MaskAndon Health Co, Ltd.20200—
+8K202463Disposable Surgical MaskUnisources Group, LLC20204—
+8K201517Plain Surgical MaskAok Tooling Limited20200—
+9K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.20260—
+9K232112R&G Surgical MaskR&G Seguridad E Higiene Industrial S.A.C.20240—
+9K232359Surgical face maskKingstar Medical (Xianning) Co., Ltd.20230—
+9K2316183 Layer Surgical Mask (134252531)Original Mattress Factory, Inc.20230—
+9K230395Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)Durio Ppe Sdn Bhd20230—
+9K213601Surgical MaskWuhan Zonsen Medical Products Co., Ltd.20220—
+9K221976Surgical Face Mask (Non-sterile)Xiantao Junhui Plastic Products Co., Ltd.20220—
+9K221038Disposable Medical MasksHantech Medical Device Co., Ltd.20220—
+9K220876AOK 95A Medical Mask (20200049)Aok Tooling Limited20220—
+9K221196Disposable Medical Face Mask (ear loop)Xiantao Topmed Nonwoven Protective Products Co., Ltd.20221—
+9K220550Disposable Surgical Face Mask (M663BE, M663BT)Makrite Industries, Inc.20220—
+9K220824Medical Surgical Mask (Planar type)Hunan Chopard Medical Devices Co., Ltd.20220—
+9K220749Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOPUnimax Medical Products Co., Ltd.20220—
+9K220512Disposable Surgical Face Mask (M01, M02)Fomed Industries, Inc.20220—