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
+4K212330Yadu Medical Face Mask (Level 1)Henan Yadu Industrial Co., Ltd.20220—
+4K213724Medical Surgical MaskHunan Zhenheyikang Medical Instrument Co., Ltd.20220—
+4K203161Surgical Face MaskWuhan Raytex Protection Co., Ltd.20220—
+4K211833Disposable Medical Face MaskZhejiang the Purples Protective Products Co.,Ltd20220—
+4K212997Surgical MaskGuangdong Zhizhen Biological Medical Co., Ltd.20220—
+4K210147Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face…Unicoglobal, Inc.20211—
+4K211696Disposable Surgical Face MaskAnhui Cleanpro Pharmpack Co., Ltd.20210—
+4K212293Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)Jiangmen Ningrui Medical Supplies Co., Ltd.20213—
+4K210845Disposable Surgical Mask (Model: YYKZ-01)Jiaxing Amazing Travel-Ware Co., Ltd.20210—
+4K210698ECOMA Level 2 Disposable Surgical Mask with Ear LoopsXianning Eco Medical Articles Co., Ltd.20210—
+4K202899Procedure Mask, Surgical MaskKenpax International Limited20211—
+4K202761Medical Surgical Mask (Non-sterile)Guangdong Goodfeeling Hygiene Material Tec Co., Ltd.20212—
+4K202655Disposable Medical MaskDongguan Runlin Medical Supplies Technology Co., Ltd.20210—
+4K210023Surgical Face MaskGuangdong Winsun Personal Care Products Co.,Ltd20210—
+4K201924Single-Use Surgical MaskQiqihar Hengxin Medical Supplies, Ltd.20211—
+4K202548Surgical Face MaskWanxinda (Guangzhou) Technology Product Co., Ltd.20210—
+4K202710Disposable Medical Face MaskWanxinda (Guangzhou) Technology Product Co., Ltd.20210—
+4K202205Surgical Face MaskJiangsu Micsafe Medical Technology Co., Ltd.20210—
+4K202214IFM Surgical Mask Model SM3Fssc, LLC20210—
+4K202358Protective Face Mask for Medical UseHunan Heng Chang Pharmaceutical Co., Ltd.20210—
+4K201537Protective Face Mask for Medical UseShandong Shengquan New Material Co., Ltd.20204—
+4K192374Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam StripCardinal Health200, LLC20193—
+4K190308Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom…Amd Medicom, Inc.20190—
+4K1808743M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield3M Healthcare20182—
+4K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd.2016158—
+5K250082Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.20250—
+5K240258Disposable Medical Face Mask (M643BE)Makrite Industries, Inc.20240—
+5K223823Disposable Surgical Face MaskEfofex, Inc.20231—
+5K223232Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.20231—
+5K220302Disposable surgical face maskShandong Aida Medical Products Co., Ltd.20220—
+5K222266Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)Jingzhou Haixin Green Cross Medical Products Co., Ltd.20220—
+5K222204Medical Surgical MaskGuangzhou Zhengkang Medical Equipment Co.,Ltd20220—
+5K220777Surgical face maskHubei Qianjiang Kingphar Medical Material Co., Ltd.20221—
+5K221173Surgical Mask (Model: 0868F, 0866F)Jiangxi Sanhao Medical Instruments Co.,Ltd20220—
+5K221134Procedure Mask with Ear Loops and Surgical Mask with TiesSafesource Direct, LLC20220—
+5K220187Medical Surgical Mask (Model: JM92, JM92B)Guangdong Jia Mei Biological Technology Co.Ltd20220—
+5K214094ROKI Surgical MaskRoki Co., Ltd.20220—
+5K212826Disposable Medical MaskJiangsu Nanfang Medical Co., Ltd.20220—
+5K211378LM Surgical Mask Level 3, LM Surgical Mask Level 2,Liberty Mask, LLC20210—
+5K210744Surgical MaskChongqing PA Xijia Biotechnology Co., Ltd.20210—
+5K212867Medical Surgical MaskNanchang Kanghua Health Materials Co., Ltd.20210—
+5K212205Medical Protective MasksQinhuangdao Taizhi Medical Technology Co., Ltd.20211—
+5K211832Fluid Resistant Procedure Mask, Fluid Resistant Surgical MaskZhejiang Lanhine Medical Products, Ltd.20210—
+5K211762Altor Safety 4-Ply Surgical Mask (Model:62232)Altor Safety, LLC20211—
+5K211576WYZ Surgical MaskWyz Medical Supplies, LLC20210—
+5K210409Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd.20210—
+5K210267Disposable Surgical MaskXiamen Eagledon Pharmaceutical Co., Ltd.20210—
+5K210445Nordiwell Surprotect Face MaskChangzhou Combat Protective Equipment Co., Ltd.20211—
+5K210840Disposable Surgical MaskSafeway Industry Healthcare.20210—
+5K203732Surgical Face MaskZhuhai Gaoge Medical Technology Co., Ltd.20210—
+5K210641Disposable Medical MaskTuosheng Protective Products (Ningbo) Co., Ltd.20210—
+5K210030Medical Surgical MaskTianjin Aoshang Outdoor Equipment Co., Ltd.20214—
+5K202513Disposable Medical Face Mask-Model FM-04Shenzhen Jinko Industrial Co., Ltd.20211—
+5K203801Disposable Surgical Face MaskAnhui Jiabao Protective Equipments Co., Ltd.20211—
+5K202191Surgical MaskWuhan Zonsen Medical Products Co., Ltd.20210—
+5K210487MIPLNI YK-244 Disposable Surgical MaskHunan Yuankang Biological Technology Co., Ltd.20210—
+5K203775AIC disposable medical maskThe Aleen International Corporation20210—
+5K202161Surgical Face MaskHunan Eexi Technology & Service Co., Ltd.20211—
+5K202409Surgical MaskAllmed Medical Products Co., Ltd.20210—
+5K202439Disposable Medical Face MaskHunan Eexi Technology & Service Co., Ltd.20210—
+5K203524Surgical MasksBain Medical Equipment (Guangzhou) Co., Ltd.20210—
+5K201732Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3…Dukal Corporation20210—
+5K202605Standard Procedure Mask, Standard Surgical MaskJiangsu Medplus Non-Woven Manufacturer Co., Ltd.20212—
+5K202627Medical Face MasksGuilin Hbm Sanitary Protections, Inc.20210—
+5K202331Medical Face MaskGemtier Medical (Shanghai), Inc.20210—
+5K202323Disposable Medical Surgical MasksTianjin Teda Jinshan Easy Packing Manufacture Co., Ltd.20210—
+5K2020963-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-OnEcoguard, Inc.20212—
+5K202640Surgical MaskJiangsu Medpure Biological Technology Co., Ltd.20210—
+5K202107Medical Protective MaskGuangdong Kingfa Sci. & Tech.Co., Ltd.20211—
+5K202594Medical Surgical Masks-Non SterileShandong T&F Nonwoven Co., Ltd.20212—
+5K202719Disposable Medical Face MasksJiangxi Sanxin Medtec Co., Ltd.20212—
+5K202211Disposable Medical Surgical Face MasksGuangdong Kaidi Garments Co.,Ltd20203—
+5K201629Medical Face MaskShandong Shengquan New Material Co., Ltd.20203—
+5K202277Surgical Face MaskJiangxi 3l Medical Products Group Co., Ltd.20200—
+5K201691Single-Use Surgical Mask With Ear LoopQiqihar Hengxin Medical Supplies, Ltd.20203—
+5K202354Surgical Mask-Model Number CW01Hunan Heng Chang Pharmaceutical Co., Ltd.20201—
+5K200923Single-use Surgical MaskByd Precision Manufacturer Co., Ltd.202016—
+5K182515Surgical Face MaskWuhan Dymex Healthcare Co., Ltd.201950—
+5K182514Surgical Face MaskXiantao Zhibo Non-Woven Products Co., Ltd.201929—
+6K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.20260—
+6K240916Surgical Face Mask (Tie on/ Ear loops)Xiantao Daoqi Plastic Co., Ltd.20240—
+6K231719Medical Surgical MaskAzur Medical Company, Inc.20240—
+6K221209PRECISION ECO Compostable / Plant Based Procedural Mask with EarloopsPadm Medical, Inc.20230—
+6K223686Medical Protective MasksQinhuangdao Taizhi Medical Technology Co., Ltd.20230—
+6K214035LAITEST Medical Face MaskR&R Medical Corporation, Ltd.20220—
+6K221957Savewo ClassicMASKSavewo Limited20220—
+6K203078CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AWHuizhou Tianchang Industrial Co., Ltd.20220—
+6K220378Sparta 3-Ply Surgical Disposable Face MaskSparta East, LLC20220—
+6K220597Disposable Surgical Face Mask (FM-34EE,FM-44EE)Qingdao Bestex Rubber & Plastic Products Co., Ltd.20221—
+6K220532Disposable surgical maskXiamen Blue Star Enterprise Co., Ltd.20220—
+6K220487Disposable Medical Face MaskHubei Mediunion Medical Products Co., Ltd.20220—
+6K2206373 Ply Medical Grade Single Use Procedural Disposable Face MaskKdi Med Supply20220—
+6K213347ADI Medical Surgical Face MaskAsia Dynamics Inc., D/B/A Adi Medical20220—
+6K212913Surgical Face MaskJiangxi Ganlong Pharmaceutical Co., Ltd.20220—
+6K212299Medical Surgical MaskWepon Medical Technology Co., Ltd.20220—
+6K213136CPL Surgical Face MaskControl Print Limited20210—
+6K212059Surgical Face MaskZhongshan Saifute Labor Protective Articles Co., Ltd.20210—
+6K210102Topwide Surgical Face MaskTopwide (Hubei) Medical Products Manufacturer20210—
+6K212944Disposable Surgical MaskHeilongjiang Yinjia Medical Equipment Co., Ltd.20210—
+6K212574Surgical Face MaskXiantao Deming Healthcare Products Co., Ltd.20210—