510(k) Report

Devices descending from K133070

170 later devices reach SURGICAL FACE MASK (Ear Loops and Tie-on) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212926AllureTM Surgical MaskAllure Gift Wraps Private Limited20220—
+1K211696Disposable Surgical Face MaskAnhui Cleanpro Pharmpack Co., Ltd.20210—
+1K210698ECOMA Level 2 Disposable Surgical Mask with Ear LoopsXianning Eco Medical Articles Co., Ltd.20210—
+1K202899Procedure Mask, Surgical MaskKenpax International Limited20211—
+1K202761Medical Surgical Mask (Non-sterile)Guangdong Goodfeeling Hygiene Material Tec Co., Ltd.20212—
+1K210023Surgical Face MaskGuangdong Winsun Personal Care Products Co.,Ltd20210—
+1K202548Surgical Face MaskWanxinda (Guangzhou) Technology Product Co., Ltd.20210—
+1K202710Disposable Medical Face MaskWanxinda (Guangzhou) Technology Product Co., Ltd.20210—
+1K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd.2016158—
+2K223823Disposable Surgical Face MaskEfofex, Inc.20231—
+2K220302Disposable surgical face maskShandong Aida Medical Products Co., Ltd.20220—
+2K220777Surgical face maskHubei Qianjiang Kingphar Medical Material Co., Ltd.20221—
+2K221134Procedure Mask with Ear Loops and Surgical Mask with TiesSafesource Direct, LLC20220—
+2K212826Disposable Medical MaskJiangsu Nanfang Medical Co., Ltd.20220—
+2K211378LM Surgical Mask Level 3, LM Surgical Mask Level 2,Liberty Mask, LLC20210—
+2K210744Surgical MaskChongqing PA Xijia Biotechnology Co., Ltd.20210—
+2K212867Medical Surgical MaskNanchang Kanghua Health Materials Co., Ltd.20210—
+2K211832Fluid Resistant Procedure Mask, Fluid Resistant Surgical MaskZhejiang Lanhine Medical Products, Ltd.20210—
+2K211576WYZ Surgical MaskWyz Medical Supplies, LLC20210—
+2K210409Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd.20210—
+2K210267Disposable Surgical MaskXiamen Eagledon Pharmaceutical Co., Ltd.20210—
+2K210840Disposable Surgical MaskSafeway Industry Healthcare.20210—
+2K203732Surgical Face MaskZhuhai Gaoge Medical Technology Co., Ltd.20210—
+2K210641Disposable Medical MaskTuosheng Protective Products (Ningbo) Co., Ltd.20210—
+2K210030Medical Surgical MaskTianjin Aoshang Outdoor Equipment Co., Ltd.20214—
+2K202513Disposable Medical Face Mask-Model FM-04Shenzhen Jinko Industrial Co., Ltd.20211—
+2K203801Disposable Surgical Face MaskAnhui Jiabao Protective Equipments Co., Ltd.20211—
+2K202191Surgical MaskWuhan Zonsen Medical Products Co., Ltd.20210—
+2K201624Spin Care Disposable Protective MaskSpintech, LLC20210—
+2K210487MIPLNI YK-244 Disposable Surgical MaskHunan Yuankang Biological Technology Co., Ltd.20210—
+2K203775AIC disposable medical maskThe Aleen International Corporation20210—
+2K202161Surgical Face MaskHunan Eexi Technology & Service Co., Ltd.20211—
+2K202409Surgical MaskAllmed Medical Products Co., Ltd.20210—
+2K202439Disposable Medical Face MaskHunan Eexi Technology & Service Co., Ltd.20210—
+2K203524Surgical MasksBain Medical Equipment (Guangzhou) Co., Ltd.20210—
+2K202605Standard Procedure Mask, Standard Surgical MaskJiangsu Medplus Non-Woven Manufacturer Co., Ltd.20212—
+2K202627Medical Face MasksGuilin Hbm Sanitary Protections, Inc.20210—
+2K202331Medical Face MaskGemtier Medical (Shanghai), Inc.20210—
+2K202323Disposable Medical Surgical MasksTianjin Teda Jinshan Easy Packing Manufacture Co., Ltd.20210—
+2K2020963-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-OnEcoguard, Inc.20212—
+2K202640Surgical MaskJiangsu Medpure Biological Technology Co., Ltd.20210—
+2K202594Medical Surgical Masks-Non SterileShandong T&F Nonwoven Co., Ltd.20212—
+2K202719Disposable Medical Face MasksJiangxi Sanxin Medtec Co., Ltd.20212—
+2K202211Disposable Medical Surgical Face MasksGuangdong Kaidi Garments Co.,Ltd20203—
+2K201629Medical Face MaskShandong Shengquan New Material Co., Ltd.20203—
+2K202277Surgical Face MaskJiangxi 3l Medical Products Group Co., Ltd.20200—
+2K201691Single-Use Surgical Mask With Ear LoopQiqihar Hengxin Medical Supplies, Ltd.20203—
+2K202354Surgical Mask-Model Number CW01Hunan Heng Chang Pharmaceutical Co., Ltd.20201—
+2K200923Single-use Surgical MaskByd Precision Manufacturer Co., Ltd.202016—
+2K182515Surgical Face MaskWuhan Dymex Healthcare Co., Ltd.201950—
+2K182514Surgical Face MaskXiantao Zhibo Non-Woven Products Co., Ltd.201929—
+3K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.20260—
+3K240916Surgical Face Mask (Tie on/ Ear loops)Xiantao Daoqi Plastic Co., Ltd.20240—
+3K231719Medical Surgical MaskAzur Medical Company, Inc.20240—
+3K214035LAITEST Medical Face MaskR&R Medical Corporation, Ltd.20220—
+3K221957Savewo ClassicMASKSavewo Limited20220—
+3K203078CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AWHuizhou Tianchang Industrial Co., Ltd.20220—
+3K221409Paneffort 3-ply Surgical and Procedural MasksPaneffort, LLC20220—
+3K220378Sparta 3-Ply Surgical Disposable Face MaskSparta East, LLC20220—
+3K220597Disposable Surgical Face Mask (FM-34EE,FM-44EE)Qingdao Bestex Rubber & Plastic Products Co., Ltd.20221—
+3K220532Disposable surgical maskXiamen Blue Star Enterprise Co., Ltd.20220—
+3K220487Disposable Medical Face MaskHubei Mediunion Medical Products Co., Ltd.20220—
+3K2206373 Ply Medical Grade Single Use Procedural Disposable Face MaskKdi Med Supply20220—
+3K213347ADI Medical Surgical Face MaskAsia Dynamics Inc., D/B/A Adi Medical20220—
+3K212913Surgical Face MaskJiangxi Ganlong Pharmaceutical Co., Ltd.20220—
+3K212299Medical Surgical MaskWepon Medical Technology Co., Ltd.20220—
+3K213136CPL Surgical Face MaskControl Print Limited20210—
+3K212059Surgical Face MaskZhongshan Saifute Labor Protective Articles Co., Ltd.20210—
+3K210102Topwide Surgical Face MaskTopwide (Hubei) Medical Products Manufacturer20210—
+3K212944Disposable Surgical MaskHeilongjiang Yinjia Medical Equipment Co., Ltd.20210—
+3K212574Surgical Face MaskXiantao Deming Healthcare Products Co., Ltd.20210—
+3K202794Surgical face mask: F-Y1-AJiande Chaomei Daily Chemicals Co., Ltd.20210—
+3K212235Surgical Face MaskShanghai Yunqing Industrial Co., Ltd.20210—
+3K212807Surgical MasksWeihai Hongyu Nonwoven Fabric Products Co., Ltd.20210—
+3K202842Medical surgical maskHenan Huibo Medical Co., Ltd.20210—
+3K211956039 Surgical Face MaskAok Tooling Limited20211—
+3K210042Disposable Surgical MaskSuzhou Letian Protective Products Co., Ltd.20210—
+3K212344Surgical MaskXiantao Dingcheng Non-Woven Product Co., Ltd.20211—
+3K212575Surgical Face MaskHubei Huanfu Plastic Products Co., Ltd.20210—
+3K202676Disposable Medical Face MaskZhejiang Senhong Medical&Instrument Co., Ltd.20210—
+3K211425Private Stock Labs Surgical Face MaskJ.K. Private Stock, Inc.20210—
+3K211899Surgical Face MaskHubei Yi-Ya Protective Products Co., Ltd.20211—
+3K211827Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)Zhejiang Lanhine Medical Products, Ltd.20216—
+3K211097Banyan USA Surgical Mask Level 3Banyan USA, LLC20210—
+3K203418Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))Ningbo Ouhan Medical Device Co., Ltd.20210—
+3K203455Disposable Medical MaskFujian Kang Chen Daily Necessities Co., Ltd.20210—
+3K211296Surgical face maskSunsmed Protective Products, Ltd.20210—
+3K202746Surgical maskNingbo Jingeao Electronics, Inc.20210—
+3K211451Disposable Surgical Mask (non sterile)Qinhuangdao Taizhi Medical Technology Co., Ltd.20210—
+3K202745Disposable medical face maskNingbo Jingeao Electronics, Inc.20211—
+3K211552Surgical maskShandong Shengquan New Materials Co., Ltd.20212—
+3K211897Surgical Face MaskZhejiang Hongyu Medicali Commodity Co., Ltd.20211—
+3K210870MEO Med Disposable Medical Face MaskFujian Meo Medical Technology Limited20210—
+3K210856Purism Disposable Surgical MaskChuzhou Daddy'S Choice Science and Technology Co., Ltd.20210—
+3K211984MASC Surgical MaskMid-America Safety Corp.20210—
+3K203534Surgical face mask (Model: Flat Ear Loop/CN102)Crown Name Disposable Hygiene Products Fty., Ltd.20210—
+3K210761Velguard Surgical Face MaskEsstee Exports Health Care Division20210—
+3K211042Disposable Procedural Ear-loop Face MaskChangzhou Dsb Medical Co., Ltd.20210—
+3K203591Single-use Medical Face MaskConod Medical Co., Limited20211—
+3K202714Medical Face MaskChongqing Chaoke Industry Development Co., Ltd.20210—