510(k) Report

Devices descending from K022256

77 later devices reach Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102713Tiger Flat Surgical MaskTiger Medical Products, Ltd.20110—
+1K093901Surgical Face MaskEpard Protective Products, Ltd.20100—
+1K090131DS N95 Surgical Masks and Flat SurgicalShanghai Dasheng Health Products20090—
+1K061716Prestige Ameritech Face MaskPrestige Ameritech200661—
+1K060776Surgical Face MaskHong YA Non-Woven Products Co., Ltd.200673—
+1K043199Surgical Face MaskHong YA Non-Woven Products Co., Ltd.20050—
+2K122717Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd.201245—
+2K103150Kimberly-Clark Child/Pediatric Face MaskKimberly-Clark20116—
+2K101128Biofriend Biomask Surgical Facemask, Models Universal BF-200-2001 and Premium BF-200-3013Filligent Limited20114—
+2K090414Spectrashield 9500 Surgical MaskNexera Medical, Inc.20112—
+2K101000Wellmien Surgical MaskWellmien (Suzhou) Import & Export Trading Co., Ltd.20104—
+2K063043Surgical Face Mask, Type: Tie-on, Ear-LoopModern Healthcare Corp.20075—
+3K220520PM Excellence SEQUR 100 Surgical Face MaskPm Excellence, LLC20220—
+3K210256CiRx (R) Surgical MaskNingbo Shun YE Medical Company, Ltd.20210—
+3K201549Motex Anti-Fog Surgical Face MaskModern Healthcare Corp.20201—
+3K192105Innonix Antiviral Child's Face MaskInnonix Technologies Limited20190—
+3K182766Cufitec Surgical MaskNbc Meshtec, Inc.20190—
+3K173062Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation201835—
+3K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC20167—
+3K123787Greencross Surgical MaskJingzhou Haixin Green Cross Medical Products Co.,L20132—
+3K123115Acme Surgical Face Mask with Ear-Loop Model YN-501 AB/W/G/PAcme Filter Mask, Inc.20132—
+3K122702Biofriend Biomask N95 Surgical RespiratorFilligent Limited20131—
+3K120244Spectrashield 9500 Surgical N95 RespiratorNexera Medical, Inc.20121—
+3K113340Kimberly-Clark Child's FacemaskKimberly-Clark20125—
+4K213427PRIMED Pediatric FacemaskPrimed Medical Products, Inc.20220—
+4K203376ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400GMedtecs (Taiwan) Corp.20220—
+4K212863Surgical Face MaskTaiwan Comfort Champ Manufacturing Co., Ltd.20220—
+4K211487MAF GuardMaf Clothing Pvt Ltd Unit-320210—
+4K202126Disposable Surgical MaskShenzhen Peninsula Medical Co., Ltd.20210—
+4K203388Disposable medical maskEverwin Toys (Dongguan)., Ltd.20210—
+4K203704Surgical face maskJuntech (Jiaxing)Healthcare Materials Co,.Ltd20210—
+4K201095Sovereign America Surgical Face MaskHomtex, Inc.20210—
+4K202628Disposable Medical Face MaskQinghai Zhong Dao Win-Win Medical Protective Equipment Co.,20210—
+4K201974Single-use medical face maskGuangdong Horigen Mother & Baby Products Co., Ltd.20210—
+4K202316Medical mask (Model: KKF-1A)Han Zhaoqing Sporting Goods Company Limited20210—
+4K202904Surgical Face MaskJiangxi Feilikang Medical Technology Co., Ltd.20211—
+4K202843Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.20215—
+4K202719Disposable Medical Face MasksJiangxi Sanxin Medtec Co., Ltd.20212—
+4K202029Medical Surgical MaskBeijing Biosis Healing Biolog Ical Technology Co., Ltd.20202—
+4K201622Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd.20202—
+4K201479DemeMASKDemetech Corporation202017—
+4K160100Prestige Ameritech Pediatric/Child’s Face maskPrestige Ameritech20164—
+4K150729SpectraShield 9500 Surgical N95 RespiratorNexera Medical, Inc.20150—
+4K141085WestTec Procedure Facemask;WestTec Surgical FacemaskWesttec, LLC20151—
+5K233723Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd.20240—
+5K221753Kangbeier Child Surgical MaskXinxiang Kangbeier Medical Technology Co., Ltd.20230—
+5K231155Biodegradable Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd.20230—
+5K212649Disposable Surgical Face MaskLyncmed Medical Technology (Beijing) Co., Ltd.20220—
+5K222335Surgical MaskLuoyang Sunmed Devices Co., Ltd.20220—
+5K213450Medical surgical mask (Black mask, Level 1 and Level 3)Guangdong Kingfa Sci. & Tech.Co., Ltd.20220—
+5K210321Dukal Corporation Level 1 Pediatric Face MaskDukal Corporation20221—
+5K212726Disposable Medical Surgical MaskHubei Huaqiang High-Tech Co., Ltd.20220—
+5K213920Kangbeier Surgical Mask (Model: KBR-1001)Xinxiang Kangbeier Medical Technology Co., Ltd.20220—
+5K211750Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)National Bridge Industrial (S.Z.) Co., Ltd.20210—
+5K212302BAYLAB 3-Ply Surgical Mask (BEACON I)Baylab USA, LLC20210—
+5K211295Surgical Mask (sterile)Nanjing 3h Medical Products Co., Ltd.20210—
+5K213406Savvy Mask - Level 3 Surgical Face MaskTexas Medplast, LLC20210—
+5K210813Medical Surgical MaskSichuan Pharmaceutical., Inc.20210—
+5K210513UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2Universal Incorporation20210—
+5K210908Surgical MaskSichuan Prius Biotechnology Co., Ltd.20210—
+5K210184Wilson Tech Disposable Medical Face MaskWilson Tech (International) Limited20210—
+5K212451Surgical MaskRemade USA, LLC20210—
+5K210391Single-use medical face maskZhuhai Herald Datanetics Limited.20210—
+5K201844Surgical Face Mask, Surgical MaskLear Corporation20210—
+5K203591Single-use Medical Face MaskConod Medical Co., Limited20211—
+5K210518Surgical Face MaskShandong Haidike Medical Products Co., Ltd.20210—
+5K202580Disposable Surgical MaskQingdao Likangyuan Medical Device Co., Ltd.20210—
+5K210030Medical Surgical MaskTianjin Aoshang Outdoor Equipment Co., Ltd.20214—
+5K202607Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs…String King Lacrosse, LLC20210—
+5K210018Disposable Medical MaskDiasia Biomedical Technology Co., Ltd.20210—
+5K202493Medical Face MaskGemtier Medical (Shanghai), Inc.20210—
+5K190308Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom…Amd Medicom, Inc.20190—
+6K231719Medical Surgical MaskAzur Medical Company, Inc.20240—
+6K220597Disposable Surgical Face Mask (FM-34EE,FM-44EE)Qingdao Bestex Rubber & Plastic Products Co., Ltd.20221—
+6K212299Medical Surgical MaskWepon Medical Technology Co., Ltd.20220—
+6K203112Disposable Medical MaskYangzhou Runyi Arts & Crafts Co., Ltd.20210—
+7K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.20260—