510(k) Report

Devices descending from K082258

299 later devices reach Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K202794Surgical face mask: F-Y1-AJiande Chaomei Daily Chemicals Co., Ltd.20210—
+6K212235Surgical Face MaskShanghai Yunqing Industrial Co., Ltd.20210—
+6K212807Surgical MasksWeihai Hongyu Nonwoven Fabric Products Co., Ltd.20210—
+6K212740Puravita Medical Fold Flat Surgical MaskPuravita M, LLC20210—
+6K202842Medical surgical maskHenan Huibo Medical Co., Ltd.20210—
+6K211956039 Surgical Face MaskAok Tooling Limited20211—
+6K210042Disposable Surgical MaskSuzhou Letian Protective Products Co., Ltd.20210—
+6K212344Surgical MaskXiantao Dingcheng Non-Woven Product Co., Ltd.20211—
+6K212575Surgical Face MaskHubei Huanfu Plastic Products Co., Ltd.20210—
+6K202676Disposable Medical Face MaskZhejiang Senhong Medical&Instrument Co., Ltd.20210—
+6K211425Private Stock Labs Surgical Face MaskJ.K. Private Stock, Inc.20210—
+6K211899Surgical Face MaskHubei Yi-Ya Protective Products Co., Ltd.20211—
+6K211827Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)Zhejiang Lanhine Medical Products, Ltd.20216—
+6K211097Banyan USA Surgical Mask Level 3Banyan USA, LLC20210—
+6K203418Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))Ningbo Ouhan Medical Device Co., Ltd.20210—
+6K203455Disposable Medical MaskFujian Kang Chen Daily Necessities Co., Ltd.20210—
+6K211296Surgical face maskSunsmed Protective Products, Ltd.20210—
+6K202746Surgical maskNingbo Jingeao Electronics, Inc.20210—
+6K211451Disposable Surgical Mask (non sterile)Qinhuangdao Taizhi Medical Technology Co., Ltd.20210—
+6K202745Disposable medical face maskNingbo Jingeao Electronics, Inc.20211—
+6K211552Surgical maskShandong Shengquan New Materials Co., Ltd.20212—
+6K211897Surgical Face MaskZhejiang Hongyu Medicali Commodity Co., Ltd.20211—
+6K210870MEO Med Disposable Medical Face MaskFujian Meo Medical Technology Limited20210—
+6K210856Purism Disposable Surgical MaskChuzhou Daddy'S Choice Science and Technology Co., Ltd.20210—
+6K211497Surgical MaskHoneywell Safety Products20210—
+6K211984MASC Surgical MaskMid-America Safety Corp.20210—
+6K203534Surgical face mask (Model: Flat Ear Loop/CN102)Crown Name Disposable Hygiene Products Fty., Ltd.20210—
+6K210761Velguard Surgical Face MaskEsstee Exports Health Care Division20210—
+6K211042Disposable Procedural Ear-loop Face MaskChangzhou Dsb Medical Co., Ltd.20210—
+6K203591Single-use Medical Face MaskConod Medical Co., Limited20211—
+6K202714Medical Face MaskChongqing Chaoke Industry Development Co., Ltd.20210—
+6K210015Surgical Face MaskSample King Manufacturing, Ltd.20210—
+6K210433Surgical Face Mask (Ear loops and Tie-on)Wuhan Dymex Healthcare Co., Ltd.20215—
+6K210372Disposable Surgical MaskDongguan Shin YI Healthcare Products Factory20210—
+6K203190Surgical Face MaskRfx+Care Manufactoring Co., Ltd.20210—
+6K210815Disposable Face MaskBiobase Scientific (Shandong) Co., Ltd.20210—
+6K210218SURGICAL MASK, Model Name:C015Qingdao Hainuo Biological Engineering Co., Ltd.20211—
+6K210020Medical MaskZhende Medical Co., Ltd.20210—
+6K202647Surgical MaskNingbo Green Textile Co., Ltd.20210—
+6K210007Face MaskJinhua Jingdi Medical Supplies Co., Ltd.20211—
+6K202650Medical disposable face mask non sterileGuangdong Zhong Ling Industrial Group Co., Ltd.20210—
+6K201698Medical Surgical MaskHangzhou Mycode Bio-Medicine Co., Ltd.20210—
+6K201852Surgical Mask-Model Number: Ear Loop, Flat-PleatedHuizhou Foryou Medical Devices Co., Ltd.20210—
+6K203426Surgical Face Mask (non-sterile)Nantong Taiweishi Medical Technology Co., Ltd.202113—
+6K201545Surgical Face MaskAmphastar Nanjing Pharmaceuticals, Inc.20210—
+6K210063Freudenberg Surgical MaskFreudenberg Performance Materials LP20212—
+6K202511Disposable Medical Surgical MaskImprove Medical (Hunan) Co., Ltd.20214—
+6K202595Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face MaskPremier Guard USA, LLC20213—
+6K202314Procedure face mask (Model: KKF-2A)Han Zhaoqing Sporting Goods Company Limited20210—
+6K201625Disposable Medical Surgical MaskTianjin Saiyuan Technology Co., Ltd.20210—
+6K201893Disposable Surgical MaskXiamen Probtain Medical Techology Co., Ltd.20200—
+6K201380Livocare Surgical MaskAndon Health Co, Ltd.20200—
+6K202463Disposable Surgical MaskUnisources Group, LLC20204—
+6K201517Plain Surgical MaskAok Tooling Limited20200—
+7K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.20260—
+7K232112R&G Surgical MaskR&G Seguridad E Higiene Industrial S.A.C.20240—
+7K232359Surgical face maskKingstar Medical (Xianning) Co., Ltd.20230—
+7K2316183 Layer Surgical Mask (134252531)Original Mattress Factory, Inc.20230—
+7K230395Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)Durio Ppe Sdn Bhd20230—
+7K213601Surgical MaskWuhan Zonsen Medical Products Co., Ltd.20220—
+7K221976Surgical Face Mask (Non-sterile)Xiantao Junhui Plastic Products Co., Ltd.20220—
+7K221038Disposable Medical MasksHantech Medical Device Co., Ltd.20220—
+7K220876AOK 95A Medical Mask (20200049)Aok Tooling Limited20220—
+7K221196Disposable Medical Face Mask (ear loop)Xiantao Topmed Nonwoven Protective Products Co., Ltd.20221—
+7K220550Disposable Surgical Face Mask (M663BE, M663BT)Makrite Industries, Inc.20220—
+7K220824Medical Surgical Mask (Planar type)Hunan Chopard Medical Devices Co., Ltd.20220—
+7K220749Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOPUnimax Medical Products Co., Ltd.20220—
+7K220512Disposable Surgical Face Mask (M01, M02)Fomed Industries, Inc.20220—
+7K210422INTAI Surgical Mask (non-sterile)Intai Technology Corp.20220—
+7K213806Disposable Medical Face MaskXiantao Zhibo Nonwoven Products Co., Ltd.20222—
+7K213617Surgical Face MaskMegasoft (China) Co., Ltd.20221—
+7K212111Myflon Surgical Mask Level 3Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi20220—
+7K213970D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 PlyDanameco Medical Joint Stock Corporation20220—
+7K212046Impertech Surgical Face MaskImpertech Industries, Ltd.20210—
+7K212109Spin Care Disposable Protective Mask Level 3Spintech, LLC20210—
+7K211165Medical Face Masks, Model Name:MY020003Huizhou Jie Bai Purification Co., Ltd.20210—
+7K212526Surgical Face MaskSuzhou Janee Medical Technology Co., Ltd.20210—
+7K210348Disposable Medical Surgical MaskWeihai Dishang Medical Technology Co., Ltd.20210—
+7K211794Disposable surgical maskShanghai No.9 Knitting Mill Co., Ltd.20210—
+7K203112Disposable Medical MaskYangzhou Runyi Arts & Crafts Co., Ltd.20210—
+7K211536Welspun Health Surgical MaskWelspun India Limited20210—
+7K212097Disposable medical surgical maskHebei Titans Hongsen Medical Technology Co., Ltd.20212—
+7K211631Surgical Face MaskMacheng Thimble Technology Investment Co., Ltd.20214—
+7K211353Medical Face MaskShenzhen Lyttop Healthcare Limited20210—
+7K211861TAIJI Professional Series Level 3 Surgical Face MaskTaiji Medical Supplies, Inc.20210—
+7K211363Medical Face MaskHubei Kangning Protective Products Co., Ltd.20210—
+7K211249Altor Safety 3-Ply Surgical Mask (Model:62222)Altor Safety, LLC20210—
+7K210244Disposable Medical Face MaskSuzhou Bolisi Medical Technology Co., Ltd.20210—
+7K211062Medical Face MaskAmmex-Weida (Hubei) Health and Safety Products Co., Ltd.20210—
+8K232797HygenixShenzhen Hygenix Industrial Co., Ltd.20230—
+8K223055Disposable Medical Face MaskXiantao Zhuobo Industrial Co., Ltd.20220—
+8K222697Disposable Medical Face Mask (DF3-001)Wellmed Dental Medical Supply Co., Ltd.20220—
+8K222426Perfetta Moderate Medical Face MaskPhu Bao Group Company Limited20220—
+8K221273Medical Face Mask (M001)Xingyu Medical Tech Co., Ltd.20220—
+8K221272Medical Face MaskShandong Xingyu Gloves Co., Ltd.20222—
+8K221222Surgical Face Mask (HNFM0304)Shanghai Hua EN Industrial Co, Ltd.20221—
+9K230617Surgical Face Mask (L 175*95mm)Henan Chaoya Medical Equipment Co., Ltd.20230—
+9K230093Disposable 4 Layers Surgical Face MaskSocial Medical Supply, LLC20230—
+9K222651Surgical Face MaskXiantao Sanda Industrial Co., Ltd.20220—