September 24, 2021

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Chinese Mask Manufacturers FDA approved

Chinese Mask Manufacturers FDA approved

Chinese Mask Manufacturers FDA approved. FDA approved masks and released Appendix-A listing Chinese Mask Manufacturers FDA approved. FDA released the first Appendix A for apporved Chinese mask manufacturers in April 2020, and keeps updating this list. Chinese companies have exported to USA about billions masks in 2020.

FDA updated Appendix A: Autherized Respirators on Oct 15, 2020

Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China (Updated: October 15, 2020)

The table below includes a list of non-NIOSH respirators authorized by this Umbrella EUA for emergency use during the COVID-19 public health emergency.


The Authorized Respirators

Authorized respirators should be used in accordance with CDC’s recommendations. For the most current CDC recommendations on optimizing respirator use, please visit CDC’s webpage: Strategies for Optimizing the Supply of N95 Respirators.

Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China (Updated with Administrative Changes or Respirator Model Removals: October 15, 2020.)


ManufacturerRespirator Model(s)Instructions for Use
3M9001, 9002, 9501, 9501+, 9501V+, 9502, 9502+, 9502V+, 9505+, 9541, 9541V, 9542, 9542V, 9552, 9552V9001: IFUExternal Link Disclaimer9002: IFUExternal Link Disclaimer9501: IFUExternal Link Disclaimer9501+: IFUExternal Link Disclaimer9501V+: IFUExternal Link Disclaimer9502: IFUExternal Link Disclaimer9502+: IFUExternal Link Disclaimer9502V+: IFUExternal Link Disclaimer9505+: IFUExternal Link Disclaimer9541: IFUExternal Link Disclaimer9541V: IFUExternal Link Disclaimer9542: IFUExternal Link Disclaimer9542V: IFUExternal Link Disclaimer9552: IFUExternal Link Disclaimer9552V: IFUExternal Link Disclaimer
Allmed Medical Products Co., LtdLP220002IFUExternal Link Disclaimer
AnDum Protective Equipment Technology (Changzhou) Co.,Ltd.AD-1001IFUExternal Link Disclaimer
Anhui Hanxiutang Biotechnology Co., Ltd.HXT-01IFUExternal Link Disclaimer
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTDJB-RP001IFUExternal Link Disclaimer
Anhui Jinrui Auto Parts Co., Ltd.JR-01IFUExternal Link Disclaimer
Anhui Zhongke Duling Commercial Appliance Co. LtdM-9501 
Anshun Health and Medical Technology Co., Ltd.AKF6002IFUExternal Link Disclaimer
AOK Tooling Ltd. (aka Shenzhonghai Medical)20130040, 20130045A, 20180021, 20130038, 20190019, 910, 2019002920130040: IFUExternal Link Disclaimer20130045A: IFUExternal Link Disclaimer20180021: IFUExternal Link Disclaimer20130038: IFUExternal Link Disclaimer20190019: IFUExternal Link Disclaimer910: IFUExternal Link Disclaimer20190029: IFUExternal Link Disclaimer
Baoding Yinhong Yuhe Medical Device Manufacturing Co., Ltd.YH/KN95-1 
Bei Bei Safety Co Ltd.B702, B702V, B704, B704VIFUExternal Link Disclaimer
Beifa Anhui Manufacturing Co., Ltd.BF-A-01IFUExternal Link Disclaimer
Beijing Topnew Import & Export Co., Ltd.ZY95IFUExternal Link Disclaimer
BG PRECISION CO. LTDKN95-NIFUExternal Link Disclaimer
BYD Precision Manufacture Co. Ltd. DG3101, DN1102DG3101: IFUExternal Link DisclaimerDN1102: IFUExternal Link Disclaimer
Careable Biotechnology Co., Ltd.CARE002, CARE003IFUExternal Link Disclaimer
Carte Medical Equipment (Suzhou) Co., LtdK8201IFUExternal Link Disclaimer
Changsha Changjiu Medical Technology Co. Ltd.KN95-05, KN95-08IFUExternal Link Disclaimer
Changshu Dayi Health Protection Articles Co., LtdDY-3IFUExternal Link Disclaimer
Chengde Technology Co.KN95 
Chongqing China Nano Technology Co., Ltd.ZN6005IFUExternal Link Disclaimer
Chongqing Zisun (Zaisheng) Technology Corp., Ltd.ZS-ZD-FJ-1, ZS-ZD-WJ-1IFUExternal Link Disclaimer
Creative Concepts Manufacturing Ltd. aka Huizhou RD Plastic Co., Ltd02676IFUExternal Link Disclaimer
Deli Group Co., LTD.ET30000 
DONGGUAN AOXING AUDIO VISUAL EQUIPMENT CO.,LTDAX-KF95 
Dongguan Arun Industrial Co., LTDKN95 N9IFUExternal Link Disclaimer
Dongguan City Outdoorsy Co., Ltd.OD-001IFUExternal Link Disclaimer
Dongguan Pan American Electronics Co., Ltd.KN95-01, KN95-02, N1001KN95-01: IFUExternal Link DisclaimerKN95-02: IFUExternal Link DisclaimerN1001: IFUExternal Link Disclaimer
Dongguan Rysam Medical Equipment Manufacturing Co.Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99VIFUExternal Link Disclaimer
Dongguan Sengtor Plastics Products Co., Ltd.KN95IFUExternal Link Disclaimer
Donghua Siecom Communication Technology Co.,LtdZGKNM-01IFUExternal Link Disclaimer
ESound Medical Device Co., Ltd.20182140615 FoldedIFUExternal Link Disclaimer
FOSHAN FLOCON MEDICAL EQUIPMENTS CO., LTDM1 
Foshan Nanhai Chuanzhishang Clothing Co., LTDCZ-S02 
Fujian Dahong Industrial Development Co. Ltd.PGT-0095 
Fujian Leephick Pharmaceutical Industry Co. Ltd.KPM-3IFUExternal Link Disclaimer
Fujian Yifa Healthcare Products Co., Ltd.Y195IFUExternal Link Disclaimer
Fujian Yongtai Sanlian Garment Co., Ltd.N95 Particulate Respirator (Xier) 
Fuzhou Chunlan Medical Equipment Co., Ltd.CL-P1IFUExternal Link Disclaimer
Guangdong GangRong Medical Technology Co., LtdGR200IFUExternal Link Disclaimer
GUANGDONG GOLDEN LEAVES TECHNOLOGY DEVELOPMENT CO., LTD.8862 KN95IFUExternal Link Disclaimer
GUANGDONG JINGCOS CO., LTD95J1 
Guangdong KINGFA SCI. & TECH. Co. Ltd.KF-A F01, KF-A F10(SC)IFUExternal Link Disclaimer
Guangdong Languan Medical Biotechnology Co., Ltd.LGKN95IFUExternal Link Disclaimer
Guangdong Nuokang Medical Technology Co., Ltd.KN95 Non-Surgical Disposable Particulate FFRIFUExternal Link Disclaimer
Guangdong Seyouse Technology and Culture CO,.LTDSS-001 
Guangdong Tengrui Pharmaceutical Technology Co., Ltd.LSH-201IFUExternal Link Disclaimer
Guangdong Willing Technology CorporationWL-01IFUExternal Link Disclaimer
Guangdong Winsun Personal Care Products Co., Ltd.YS0003IFUExternal Link Disclaimer
Guangdong Yidao MedicalYD-002IFUExternal Link Disclaimer
Guangdong Zhizhen Biological Medicine Co., Ltd.KN95 Three-Dimensional Protective Face MaskIFUExternal Link Disclaimer
Guangxi MC Medical equipment Co., Ltd​MC010501IFUExternal Link Disclaimer
GUANGZHOU BIOFIL AIR PURIFICATION MATERIALS CO.,LTDMY3D2IFUExternal Link Disclaimer
Guangzhou Bofeite Safety Protective Supplies Co., Ltd.HT9510V, HT9510 
Guangzhou Carrot Mall Network Technologies Co., Ltd.IRYS-01IFUExternal Link Disclaimer
Guangzhou Harley Commodity Company LimitedL-103V KN95IFUExternal Link Disclaimer
Guangzhou Nan Qi Xing Non-Woven Co., Ltd.KN-1 RespiratorIFUExternal Link Disclaimer
Guangzhou Powecom Labor Insurance Supplies Co., LTDKN95IFUExternal Link Disclaimer
Guanyang Yunhan Textile Co., Ltd.YH-9500IFUExternal Link Disclaimer
Haishi Hainuo Lexiang Medical Technology (Qingdao) Co., Ltd.LX1001 
HANGZHOU FILTECH INTELLIGENT CO., LTD.Filtech Face Mask Model F860, F862, F890V, F891V, F890, F861 F860: IFUExternal Link DisclaimerF862: IFUExternal Link DisclaimerF890V: IFUExternal Link DisclaimerF891V: IFUExternal Link Disclaimer
Hangzhou Gang Yu Health Products Co., Ltd.GY2020001IFUExternal Link Disclaimer
Hangzhou San Qiang Safety Protection Products Co., Ltd.9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3)9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9480V (FFP2): IFUExternal Link Disclaimer9980V (FFP3), 9920V (FFP3): IFUExternal Link Disclaimer
Hebei Pengyuan Optoelectronics Co., Ltd.SUPERNOVA-P2IFUExternal Link Disclaimer
Henan Aklly Filter Engineering Co., Ltd.KZ888EIFUExternal Link Disclaimer
Henan Bingzun Industrial Co.,Ltd.8410IFUExternal Link Disclaimer
Henan Yadu Industrial Co., LtdFlat FoldIFUExternal Link Disclaimer
Heyuan COE Communication Technology Co., Ltd.CHMM-NBIFUExternal Link Disclaimer
Hubei Huaqiang High-Tech Co., Ltd.Flat Fold (Earloop) Non-SterileIFUExternal Link Disclaimer
Hui Zhou Tian Chang Industrial Co., Ltd.N002-AWIFUExternal Link Disclaimer
Huizhou Green Communication Equipment Manufacturing Co., Ltd​G95200 Particle Filtering Half MaskIFUExternal Link Disclaimer
Huizhou Huinuo Technology Co., Ltd9501AIFUExternal Link Disclaimer
Huizhou Yibaidu Medical Device Technology Co., Ltd.YBD-2 
Hunan Boltpower Guokang Medical Equipment Co., Ltd.GK-002AIFUExternal Link Disclaimer
Hunan Changyuan Technology Co., Ltd.CY005 Filtering Half MaskIFUExternal Link Disclaimer
Hunan EEXI Technology & Service Co., Ltd.YX152, YX153YX152: IFUExternal Link DisclaimerYX153: IFUExternal Link Disclaimer
Hunan Hengchang Pharmaceutical Co., LTD.N9501-L (non-sterile type)IFUExternal Link Disclaimer
Hunan Jianyuan Medical Science and Technology Co. Ltd.JY009AIFUExternal Link Disclaimer
Hunan Kangweining Medical Devices Co., Ltd.YH-I (non-sterile) and YH-II (sterile)IFUExternal Link Disclaimer
Jiande Chaomei Daily Chemicals Co.F-Y3-AIFUExternal Link Disclaimer
Jiangmen Nostop Electric Co., LtdJW-017IFUExternal Link Disclaimer
JIANGSU CHANGMEI MEDTECH CO.,LTDDFM-01IFUExternal Link Disclaimer
JiangSu EverSmart Nano Technology Co., Ltd.HZ-KN95IFUExternal Link Disclaimer
JIANGSU HOMCAN MEDICAL TECHNOLOGY CO. LTDHC-NP95AIFUExternal Link Disclaimer
Jiangsu Jiaao Medical Technology Co., Ltd.JA95-1 Filtering half maskIFUExternal Link Disclaimer
Jiangsu Kangershun Protective Equipment Co., Ltd.KES-002IFUExternal Link Disclaimer
Jiangsu Sanfo Outdoor Products Co., LtdCX9501-PIFUExternal Link Disclaimer
Jiangsu Yimao Filter Media Co., Ltd9570K, 9560K9560K9570K: IFUExternal Link Disclaimer
Jiaxing Yinuo Busway Co., Ltd.YJ-P2 
Jingzhou Strong Sciences & Technology Development Co.,ltdST-A9502, A9507ST-A9502: IFUExternal Link DisclaimerA9507: IFUExternal Link Disclaimer
Jinhua Ai Kou Protective Equipment Co.,AK003IFUExternal Link Disclaimer
Jinhua Jiadaifu Medical Supplies Co., Ltd.Disposable Non-Medical Face Mask (KN95)IFUExternal Link Disclaimer
Jinwells (Tianjin) Science and Technology Co., Ltd.JWS-1, JWS-2JWS-1: IFUExternal Link DisclaimerJWS-2: IFUExternal Link Disclaimer
Jinyi (Tianjin) Medical Technology Co., Ltd.JY9501IFUExternal Link Disclaimer
Lanshan Shendun Technology Co., Ltd.SD-KN95IFUExternal Link Disclaimer
Liaoning Dalian Jieying Energy Saving Environmental Protection Technology Development Co., Ltd.JY-FH-F, JY-FHJY-FH-F: IFUExternal Link DisclaimerJY-FH: IFUExternal Link Disclaimer
Lu’an Bi Hai Protective Equipment Co., Ltd.BH2020 
Meizhuangchen Health Technology (Shenzhen) Co., Ltd.ENKN95-001 
Naton Medical Protective Mask (Zhuozhou) Co., LtdFS9501-L, FS9501-M, FS9501-S; FS9901-L, FS9901-M, FS9901-SIFUExternal Link Disclaimer
ORICH Medical Equipment (Tianjin) Co., Ltd.N95 Folded Form (Non-sterile)IFUExternal Link Disclaimer
PURIFA Medical Production Co., Ltd.BU-E978IFUExternal Link Disclaimer
Putian Sisen Technology Co.,Ltd.AIBANA 001IFUExternal Link Disclaimer
Qingdao Bioforce-aid Technology Co., Ltd.G9501IFUExternal Link Disclaimer
Qingdao Huaren Medical Product Co.,Ltd.HRKFAM, HRKFBMIFU
Qingdao Miuton Medical Co., LtdStereoscopic type ear worn KN95 Protective MaskIFUExternal Link Disclaimer
Qingzhou Yaowang Pharmaceutical Co., LtdN95-FWJIFUExternal Link Disclaimer
Quanding Medical Supplies Co., Ltd.QD-FM004IFUExternal Link Disclaimer
Quanzhou Caier Paper Co., Ltd.CC001 
QUANZHOU LIGAO PROTECTIVE PRODUCT MANUFACTURER CO.,LTDLG-DFM-01IFUExternal Link Disclaimer
Raxwell Industrial Technology (Shanghai) Co., LtdRX9501IFUExternal Link Disclaimer
Regina Miracle (Shenzhen) Ltd.RM2020 MA-08 
Rizhao Sanqi Medical & Health Articles Co., LtdRIZ100CVb, 3Q KN95, 3Q FFP2 NR, RIZQ100Sb, 3Q KN95 9505IFUExternal Link Disclaimer
Samding Craftwork Co., Ltd.B13086IFUExternal Link Disclaimer
Shaanxi Hongji Pharmaceutical Co., Ltd.HJF-E1IFUExternal Link Disclaimer
Shandong C.I.R.S. Garments Co., Ltd.LSD008IFUExternal Link Disclaimer
Shandong Haidike Medical Products Co., Ltd​.N95-V1IFUExternal Link Disclaimer
Shandong Yuerong Network Technology Co., LtdAuben-0598 
Shanghai Dasheng Health Products Manufacture Company, Ltd.DTC3X-1, DTC3X-2, DTC3X-3, DTC3B-1DTC3X-1 IFUExternal Link DisclaimerDTC3X-2 IFUExternal Link DisclaimerDTC3X-3 IFUExternal Link DisclaimerDTC3B-1 IFUExternal Link Disclaimer
Shanghai Earntz Nonwoven Co., Ltd.EZKZ01CIFUExternal Link Disclaimer
Shanghai Gangkai Purifying Products Co. Ltd.8022, 8012, 8013IFUExternal Link Disclaimer
Shanghai Homes Mask Co,ltd CompanyHMS-801IFUExternal Link Disclaimer
Shanghai Tenry Pharmaceutical Co., Ltd.TR-ZD01IFUExternal Link Disclaimer
Shanghai Yunqing Industrial Co., Ltd.YQD95 KN95IFUExternal Link Disclaimer
Shangxian Minimal Invasive Inc.​CD9501IFUExternal Link Disclaimer
Shenyang Shengshi Medical Technology Co., Ltd.Folding type SHI002 (non-sterile)IFUExternal Link Disclaimer
Shenzhen SafeSecure Medical Infection Control Tech Co., LtdFHIFUExternal Link Disclaimer
Shenzhen SanheXing Stickers Products Co., Ltd.SHX01IFUExternal Link Disclaimer
Shenzhen Yunyifu Health Technology Co., LTD.PM-P2IFUExternal Link Disclaimer
SPRO Medical Products (Xiamen) Co., Ltd.D918, GL001, GL001AD918: IFUExternal Link DisclaimerGL001: IFUExternal Link DisclaimerGL001A: IFUExternal Link Disclaimer
Sure-On Industries Ltd210-KN95IFUExternal Link Disclaimer
Suzhou Bolisi Medical Technology Co., LtdBS-9501L, BS-9501FL, BS-9502C, BS-9502FC 
Suzhou Dongshan Precision Manufacturing Co., Ltd.​DKW00IFUExternal Link Disclaimer
Suzhou Sanical Protective Product Manufacturing Co., Ltd8015, 9015IFUExternal Link Disclaimer
Tengfei Tech. Co. Ltd.TF-9006IFUExternal Link Disclaimer
Tianjin TEDA Filters Co., Ltd.TEDA-P0652IFUExternal Link Disclaimer
Tongcheng Jiuxi Technology Co., Ltd.JX-R950IFUExternal Link Disclaimer
UFI Filters (Shanghai) Co., Ltd.35.005 
UHEALTH MEDICAL (BEIJING) PROTECTIVE PRODUCTS CO., LTD.0117IFUExternal Link Disclaimer
Violet Home Textile Technology Co., Ltd.ZLL377IFUExternal Link Disclaimer
Weini Technology Development Co., LtdFFP2 NR E-300, FFP2 NR E-680, FFP2 NR 952, FFP2 NR F-820, KN95 958, KN95 951, FFP3 NR E-830V, FFP3 NR E-340V, FFP2 NR K-220FFP2 NR E-300, FFP2 NR E-680, FFP2 NR 952, FFP2 NR F-820: IFUExternal Link DisclaimerKN95 958, KN95 951: IFUExternal Link Disclaimer
WENZHOU KADIBANG GARMENTS CO., LTD.KBD-M01 
Wilson Instruments (SHA) Co., LTDWS-KZ-S4, WS-KZ-S4EIFUExternal Link Disclaimer
Winner Medical Co., LtdWN-N95FW, WN-N95FGINIFUExternal Link Disclaimer
Wuhan Zonsen Medical Products Co., Ltd.ZSFM-01, ZSFM-02ZSFM-01: IFUExternal Link DisclaimerZSFM-02: IFUExternal Link Disclaimer
Xiamen Chengchuang Automotive Materials Co., Ltd.XPM2121IFUExternal Link Disclaimer
XIAMEN LIANYI INDUDSTIRAL & TRADING CO., LTD.LY9501IFUExternal Link Disclaimer
XIAMEN PROBTAIN NONWOVEN INC.MP9011IFUExternal Link Disclaimer
Xuan Cheng Zooboo Sports Goods Co., Ltd.ZB008IFUExternal Link Disclaimer
Yangzhou Medline Industry Co., Ltd.I 9501, II 9501I 9501: IFUExternal Link DisclaimerII 9501: IFUExternal Link Disclaimer
Yicheng Dunhou Medical Health Co., LtdDHA01IFUExternal Link Disclaimer
Yiyang Taihe Technology Co. LtdYTH0001 
YuTong Eco-Technology (SuQian) Co., LtdYT-07IFUExternal Link Disclaimer
Zhangzhou Easepal Industrial Co., Ltd.D13003 and D13003ACIFUExternal Link Disclaimer
ZHEJIANG BOSIQI CASHMERE CO., LTD.KANGJIAYI SS4020IFUExternal Link Disclaimer
Zhejiang Dongmeng Medical Equipment Co., LTDEYTV139110051-02 
Zhejiang Langqi Fashion Co., LtdXJB902IFUExternal Link Disclaimer
ZHEJIANG LILY UNDERWEAR CO., LTDFM0402-966; FM0432-966; FM0201-966FM0201-966: IFUExternal Link Disclaimer
ZHEJIANG LUYAO ELECTRONICS TECHNOLOGY CO., LTD.LY-N900-N909IFUExternal Link Disclaimer
ZHEJIANG MASHANG TECHNOLOGY CO., LTDMSNF-01IFUExternal Link Disclaimer
ZHEJIANG SHUNFA SAFETY TECHNOLOGY CO., LTDSF-K01, SF-K02IFUExternal Link Disclaimer
Zhejiang Yinda Biotechnology Co., Ltd.YD-N2IFUExternal Link Disclaimer
Zhende Medical Co., Ltd.N9501FIFUExternal Link Disclaimer
Zhengzhou Ruipu Medical Technology Co. LtdKN95IFUExternal Link Disclaimer
Zhongkang Protective Equipment Technology (Guangzhou) Co., LtdZK601; ZK626IFUExternal Link Disclaimer
Zhuhai HealthPro Medical Equipment Co., LtdHB202001-WH, HN202001HB202001-WH: IFUExternal Link DisclaimerHN202001: IFUExternal Link Disclaimer
ZIGONG WEIKANG MEDICAL EQUIPMENT CO., LTDWJKZ-2IFUExternal Link Disclaimer
ZK-BEST (Xiamen) Environmental Science & Technology Co., Ltd.ZKG9501, ZKG9501VZKG9501: IFUExternal Link DisclaimerZKG9501V: IFU
Chinese Mask Manufacturers FDA approved

Chinese mask maufactureres FDA approved

~~~~ Chinese Mask Manufacturers FDA approved ~~~~