510(k) Report

Devices descending from K131879

185 later devices reach KC 300 Surgical Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212366Heartland Health Surgical MaskHeartland Health Products20220—
+1K1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask3M Healthcare201912—
+1K133070SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd.2015170—
+2K251902Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield…Vitacore Industries, Inc.20250—
+2K222749High Fluid-Resistant Surgical and Procedure MaskAmerica’S Supply Chains20220—
+2K212926AllureTM Surgical MaskAllure Gift Wraps Private Limited20220—
+2K211771The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical…The Good Corporation20220—
+2K210147Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face…Unicoglobal, Inc.20211—
+2K211696Disposable Surgical Face MaskAnhui Cleanpro Pharmpack Co., Ltd.20210—
+2K210698ECOMA Level 2 Disposable Surgical Mask with Ear LoopsXianning Eco Medical Articles Co., Ltd.20210—
+2K202899Procedure Mask, Surgical MaskKenpax International Limited20211—
+2K202697United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid…United Sewing Automation, Inc.20210—
+2K202387Disposable Surgical Face MaskGuangdong Bida Medical Technology Co., Ltd.20210—
+2K202761Medical Surgical Mask (Non-sterile)Guangdong Goodfeeling Hygiene Material Tec Co., Ltd.20212—
+2K202655Disposable Medical MaskDongguan Runlin Medical Supplies Technology Co., Ltd.20210—
+2K210023Surgical Face MaskGuangdong Winsun Personal Care Products Co.,Ltd20210—
+2K201924Single-Use Surgical MaskQiqihar Hengxin Medical Supplies, Ltd.20211—
+2K202548Surgical Face MaskWanxinda (Guangzhou) Technology Product Co., Ltd.20210—
+2K202710Disposable Medical Face MaskWanxinda (Guangzhou) Technology Product Co., Ltd.20210—
+2K202205Surgical Face MaskJiangsu Micsafe Medical Technology Co., Ltd.20210—
+2K202214IFM Surgical Mask Model SM3Fssc, LLC20210—
+2K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd.2016158—
+3K223823Disposable Surgical Face MaskEfofex, Inc.20231—
+3K220302Disposable surgical face maskShandong Aida Medical Products Co., Ltd.20220—
+3K222266Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)Jingzhou Haixin Green Cross Medical Products Co., Ltd.20220—
+3K220777Surgical face maskHubei Qianjiang Kingphar Medical Material Co., Ltd.20221—
+3K221134Procedure Mask with Ear Loops and Surgical Mask with TiesSafesource Direct, LLC20220—
+3K214094ROKI Surgical MaskRoki Co., Ltd.20220—
+3K212826Disposable Medical MaskJiangsu Nanfang Medical Co., Ltd.20220—
+3K211378LM Surgical Mask Level 3, LM Surgical Mask Level 2,Liberty Mask, LLC20210—
+3K210744Surgical MaskChongqing PA Xijia Biotechnology Co., Ltd.20210—
+3K212867Medical Surgical MaskNanchang Kanghua Health Materials Co., Ltd.20210—
+3K211832Fluid Resistant Procedure Mask, Fluid Resistant Surgical MaskZhejiang Lanhine Medical Products, Ltd.20210—
+3K211576WYZ Surgical MaskWyz Medical Supplies, LLC20210—
+3K210409Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd.20210—
+3K210267Disposable Surgical MaskXiamen Eagledon Pharmaceutical Co., Ltd.20210—
+3K210840Disposable Surgical MaskSafeway Industry Healthcare.20210—
+3K203732Surgical Face MaskZhuhai Gaoge Medical Technology Co., Ltd.20210—
+3K210641Disposable Medical MaskTuosheng Protective Products (Ningbo) Co., Ltd.20210—
+3K210030Medical Surgical MaskTianjin Aoshang Outdoor Equipment Co., Ltd.20214—
+3K202513Disposable Medical Face Mask-Model FM-04Shenzhen Jinko Industrial Co., Ltd.20211—
+3K203801Disposable Surgical Face MaskAnhui Jiabao Protective Equipments Co., Ltd.20211—
+3K202191Surgical MaskWuhan Zonsen Medical Products Co., Ltd.20210—
+3K201624Spin Care Disposable Protective MaskSpintech, LLC20210—
+3K210487MIPLNI YK-244 Disposable Surgical MaskHunan Yuankang Biological Technology Co., Ltd.20210—
+3K203775AIC disposable medical maskThe Aleen International Corporation20210—
+3K202161Surgical Face MaskHunan Eexi Technology & Service Co., Ltd.20211—
+3K202409Surgical MaskAllmed Medical Products Co., Ltd.20210—
+3K202439Disposable Medical Face MaskHunan Eexi Technology & Service Co., Ltd.20210—
+3K203524Surgical MasksBain Medical Equipment (Guangzhou) Co., Ltd.20210—
+3K202605Standard Procedure Mask, Standard Surgical MaskJiangsu Medplus Non-Woven Manufacturer Co., Ltd.20212—
+3K202627Medical Face MasksGuilin Hbm Sanitary Protections, Inc.20210—
+3K202331Medical Face MaskGemtier Medical (Shanghai), Inc.20210—
+3K202323Disposable Medical Surgical MasksTianjin Teda Jinshan Easy Packing Manufacture Co., Ltd.20210—
+3K2020963-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-OnEcoguard, Inc.20212—
+3K202640Surgical MaskJiangsu Medpure Biological Technology Co., Ltd.20210—
+3K202594Medical Surgical Masks-Non SterileShandong T&F Nonwoven Co., Ltd.20212—
+3K202719Disposable Medical Face MasksJiangxi Sanxin Medtec Co., Ltd.20212—
+3K202211Disposable Medical Surgical Face MasksGuangdong Kaidi Garments Co.,Ltd20203—
+3K201629Medical Face MaskShandong Shengquan New Material Co., Ltd.20203—
+3K202277Surgical Face MaskJiangxi 3l Medical Products Group Co., Ltd.20200—
+3K201691Single-Use Surgical Mask With Ear LoopQiqihar Hengxin Medical Supplies, Ltd.20203—
+3K202354Surgical Mask-Model Number CW01Hunan Heng Chang Pharmaceutical Co., Ltd.20201—
+3K200923Single-use Surgical MaskByd Precision Manufacturer Co., Ltd.202016—
+3K182515Surgical Face MaskWuhan Dymex Healthcare Co., Ltd.201950—
+3K182514Surgical Face MaskXiantao Zhibo Non-Woven Products Co., Ltd.201929—
+4K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.20260—
+4K240916Surgical Face Mask (Tie on/ Ear loops)Xiantao Daoqi Plastic Co., Ltd.20240—
+4K231719Medical Surgical MaskAzur Medical Company, Inc.20240—
+4K214035LAITEST Medical Face MaskR&R Medical Corporation, Ltd.20220—
+4K221957Savewo ClassicMASKSavewo Limited20220—
+4K203078CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AWHuizhou Tianchang Industrial Co., Ltd.20220—
+4K221409Paneffort 3-ply Surgical and Procedural MasksPaneffort, LLC20220—
+4K220378Sparta 3-Ply Surgical Disposable Face MaskSparta East, LLC20220—
+4K220597Disposable Surgical Face Mask (FM-34EE,FM-44EE)Qingdao Bestex Rubber & Plastic Products Co., Ltd.20221—
+4K220532Disposable surgical maskXiamen Blue Star Enterprise Co., Ltd.20220—
+4K220487Disposable Medical Face MaskHubei Mediunion Medical Products Co., Ltd.20220—
+4K2206373 Ply Medical Grade Single Use Procedural Disposable Face MaskKdi Med Supply20220—
+4K213347ADI Medical Surgical Face MaskAsia Dynamics Inc., D/B/A Adi Medical20220—
+4K212913Surgical Face MaskJiangxi Ganlong Pharmaceutical Co., Ltd.20220—
+4K212299Medical Surgical MaskWepon Medical Technology Co., Ltd.20220—
+4K213136CPL Surgical Face MaskControl Print Limited20210—
+4K212059Surgical Face MaskZhongshan Saifute Labor Protective Articles Co., Ltd.20210—
+4K210102Topwide Surgical Face MaskTopwide (Hubei) Medical Products Manufacturer20210—
+4K212944Disposable Surgical MaskHeilongjiang Yinjia Medical Equipment Co., Ltd.20210—
+4K212574Surgical Face MaskXiantao Deming Healthcare Products Co., Ltd.20210—
+4K202794Surgical face mask: F-Y1-AJiande Chaomei Daily Chemicals Co., Ltd.20210—
+4K212235Surgical Face MaskShanghai Yunqing Industrial Co., Ltd.20210—
+4K212807Surgical MasksWeihai Hongyu Nonwoven Fabric Products Co., Ltd.20210—
+4K202842Medical surgical maskHenan Huibo Medical Co., Ltd.20210—
+4K211956039 Surgical Face MaskAok Tooling Limited20211—
+4K210042Disposable Surgical MaskSuzhou Letian Protective Products Co., Ltd.20210—
+4K212344Surgical MaskXiantao Dingcheng Non-Woven Product Co., Ltd.20211—
+4K212575Surgical Face MaskHubei Huanfu Plastic Products Co., Ltd.20210—
+4K202676Disposable Medical Face MaskZhejiang Senhong Medical&Instrument Co., Ltd.20210—
+4K211425Private Stock Labs Surgical Face MaskJ.K. Private Stock, Inc.20210—
+4K211899Surgical Face MaskHubei Yi-Ya Protective Products Co., Ltd.20211—
+4K211827Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)Zhejiang Lanhine Medical Products, Ltd.20216—
+4K211097Banyan USA Surgical Mask Level 3Banyan USA, LLC20210—
+4K203418Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))Ningbo Ouhan Medical Device Co., Ltd.20210—