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Chinese Mask Manufacturers FDA approved
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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.)
| Manufacturer | Respirator Model(s) | Instructions for Use |
|---|---|---|
| 3M | 9001, 9002, 9501, 9501+, 9501V+, 9502, 9502+, 9502V+, 9505+, 9541, 9541V, 9542, 9542V, 9552, 9552V | 9001: 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., Ltd | LP220002 | IFUExternal Link Disclaimer |
| AnDum Protective Equipment Technology (Changzhou) Co.,Ltd. | AD-1001 | IFUExternal Link Disclaimer |
| Anhui Hanxiutang Biotechnology Co., Ltd. | HXT-01 | IFUExternal Link Disclaimer |
| ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | IFUExternal Link Disclaimer |
| Anhui Jinrui Auto Parts Co., Ltd. | JR-01 | IFUExternal Link Disclaimer |
| Anhui Zhongke Duling Commercial Appliance Co. Ltd | M-9501 | |
| Anshun Health and Medical Technology Co., Ltd. | AKF6002 | IFUExternal Link Disclaimer |
| AOK Tooling Ltd. (aka Shenzhonghai Medical) | 20130040, 20130045A, 20180021, 20130038, 20190019, 910, 20190029 | 20130040: 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, B704V | IFUExternal Link Disclaimer |
| Beifa Anhui Manufacturing Co., Ltd. | BF-A-01 | IFUExternal Link Disclaimer |
| Beijing Topnew Import & Export Co., Ltd. | ZY95 | IFUExternal Link Disclaimer |
| BG PRECISION CO. LTD | KN95-N | IFUExternal Link Disclaimer |
| BYD Precision Manufacture Co. Ltd. | DG3101, DN1102 | DG3101: IFUExternal Link DisclaimerDN1102: IFUExternal Link Disclaimer |
| Careable Biotechnology Co., Ltd. | CARE002, CARE003 | IFUExternal Link Disclaimer |
| Carte Medical Equipment (Suzhou) Co., Ltd | K8201 | IFUExternal Link Disclaimer |
| Changsha Changjiu Medical Technology Co. Ltd. | KN95-05, KN95-08 | IFUExternal Link Disclaimer |
| Changshu Dayi Health Protection Articles Co., Ltd | DY-3 | IFUExternal Link Disclaimer |
| Chengde Technology Co. | KN95 | |
| Chongqing China Nano Technology Co., Ltd. | ZN6005 | IFUExternal Link Disclaimer |
| Chongqing Zisun (Zaisheng) Technology Corp., Ltd. | ZS-ZD-FJ-1, ZS-ZD-WJ-1 | IFUExternal Link Disclaimer |
| Creative Concepts Manufacturing Ltd. aka Huizhou RD Plastic Co., Ltd | 02676 | IFUExternal Link Disclaimer |
| Deli Group Co., LTD. | ET30000 | |
| DONGGUAN AOXING AUDIO VISUAL EQUIPMENT CO.,LTD | AX-KF95 | |
| Dongguan Arun Industrial Co., LTD | KN95 N9 | IFUExternal Link Disclaimer |
| Dongguan City Outdoorsy Co., Ltd. | OD-001 | IFUExternal Link Disclaimer |
| Dongguan Pan American Electronics Co., Ltd. | KN95-01, KN95-02, N1001 | KN95-01: 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 RSN99V | IFUExternal Link Disclaimer |
| Dongguan Sengtor Plastics Products Co., Ltd. | KN95 | IFUExternal Link Disclaimer |
| Donghua Siecom Communication Technology Co.,Ltd | ZGKNM-01 | IFUExternal Link Disclaimer |
| ESound Medical Device Co., Ltd. | 20182140615 Folded | IFUExternal Link Disclaimer |
| FOSHAN FLOCON MEDICAL EQUIPMENTS CO., LTD | M1 | |
| Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
| Fujian Dahong Industrial Development Co. Ltd. | PGT-0095 | |
| Fujian Leephick Pharmaceutical Industry Co. Ltd. | KPM-3 | IFUExternal Link Disclaimer |
| Fujian Yifa Healthcare Products Co., Ltd. | Y195 | IFUExternal Link Disclaimer |
| Fujian Yongtai Sanlian Garment Co., Ltd. | N95 Particulate Respirator (Xier) | |
| Fuzhou Chunlan Medical Equipment Co., Ltd. | CL-P1 | IFUExternal Link Disclaimer |
| Guangdong GangRong Medical Technology Co., Ltd | GR200 | IFUExternal Link Disclaimer |
| GUANGDONG GOLDEN LEAVES TECHNOLOGY DEVELOPMENT CO., LTD. | 8862 KN95 | IFUExternal Link Disclaimer |
| GUANGDONG JINGCOS CO., LTD | 95J1 | |
| Guangdong KINGFA SCI. & TECH. Co. Ltd. | KF-A F01, KF-A F10(SC) | IFUExternal Link Disclaimer |
| Guangdong Languan Medical Biotechnology Co., Ltd. | LGKN95 | IFUExternal Link Disclaimer |
| Guangdong Nuokang Medical Technology Co., Ltd. | KN95 Non-Surgical Disposable Particulate FFR | IFUExternal Link Disclaimer |
| Guangdong Seyouse Technology and Culture CO,.LTD | SS-001 | |
| Guangdong Tengrui Pharmaceutical Technology Co., Ltd. | LSH-201 | IFUExternal Link Disclaimer |
| Guangdong Willing Technology Corporation | WL-01 | IFUExternal Link Disclaimer |
| Guangdong Winsun Personal Care Products Co., Ltd. | YS0003 | IFUExternal Link Disclaimer |
| Guangdong Yidao Medical | YD-002 | IFUExternal Link Disclaimer |
| Guangdong Zhizhen Biological Medicine Co., Ltd. | KN95 Three-Dimensional Protective Face Mask | IFUExternal Link Disclaimer |
| Guangxi MC Medical equipment Co., Ltd | MC010501 | IFUExternal Link Disclaimer |
| GUANGZHOU BIOFIL AIR PURIFICATION MATERIALS CO.,LTD | MY3D2 | IFUExternal Link Disclaimer |
| Guangzhou Bofeite Safety Protective Supplies Co., Ltd. | HT9510V, HT9510 | |
| Guangzhou Carrot Mall Network Technologies Co., Ltd. | IRYS-01 | IFUExternal Link Disclaimer |
| Guangzhou Harley Commodity Company Limited | L-103V KN95 | IFUExternal Link Disclaimer |
| Guangzhou Nan Qi Xing Non-Woven Co., Ltd. | KN-1 Respirator | IFUExternal Link Disclaimer |
| Guangzhou Powecom Labor Insurance Supplies Co., LTD | KN95 | IFUExternal Link Disclaimer |
| Guanyang Yunhan Textile Co., Ltd. | YH-9500 | IFUExternal 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. | GY2020001 | IFUExternal 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-P2 | IFUExternal Link Disclaimer |
| Henan Aklly Filter Engineering Co., Ltd. | KZ888E | IFUExternal Link Disclaimer |
| Henan Bingzun Industrial Co.,Ltd. | 8410 | IFUExternal Link Disclaimer |
| Henan Yadu Industrial Co., Ltd | Flat Fold | IFUExternal Link Disclaimer |
| Heyuan COE Communication Technology Co., Ltd. | CHMM-NB | IFUExternal Link Disclaimer |
| Hubei Huaqiang High-Tech Co., Ltd. | Flat Fold (Earloop) Non-Sterile | IFUExternal Link Disclaimer |
| Hui Zhou Tian Chang Industrial Co., Ltd. | N002-AW | IFUExternal Link Disclaimer |
| Huizhou Green Communication Equipment Manufacturing Co., Ltd | G95200 Particle Filtering Half Mask | IFUExternal Link Disclaimer |
| Huizhou Huinuo Technology Co., Ltd | 9501A | IFUExternal Link Disclaimer |
| Huizhou Yibaidu Medical Device Technology Co., Ltd. | YBD-2 | |
| Hunan Boltpower Guokang Medical Equipment Co., Ltd. | GK-002A | IFUExternal Link Disclaimer |
| Hunan Changyuan Technology Co., Ltd. | CY005 Filtering Half Mask | IFUExternal Link Disclaimer |
| Hunan EEXI Technology & Service Co., Ltd. | YX152, YX153 | YX152: 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. | JY009A | IFUExternal 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-A | IFUExternal Link Disclaimer |
| Jiangmen Nostop Electric Co., Ltd | JW-017 | IFUExternal Link Disclaimer |
| JIANGSU CHANGMEI MEDTECH CO.,LTD | DFM-01 | IFUExternal Link Disclaimer |
| JiangSu EverSmart Nano Technology Co., Ltd. | HZ-KN95 | IFUExternal Link Disclaimer |
| JIANGSU HOMCAN MEDICAL TECHNOLOGY CO. LTD | HC-NP95A | IFUExternal Link Disclaimer |
| Jiangsu Jiaao Medical Technology Co., Ltd. | JA95-1 Filtering half mask | IFUExternal Link Disclaimer |
| Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | IFUExternal Link Disclaimer |
| Jiangsu Sanfo Outdoor Products Co., Ltd | CX9501-P | IFUExternal Link Disclaimer |
| Jiangsu Yimao Filter Media Co., Ltd | 9570K, 9560K | 9560K9570K: IFUExternal Link Disclaimer |
| Jiaxing Yinuo Busway Co., Ltd. | YJ-P2 | |
| Jingzhou Strong Sciences & Technology Development Co.,ltd | ST-A9502, A9507 | ST-A9502: IFUExternal Link DisclaimerA9507: IFUExternal Link Disclaimer |
| Jinhua Ai Kou Protective Equipment Co., | AK003 | IFUExternal 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-2 | JWS-1: IFUExternal Link DisclaimerJWS-2: IFUExternal Link Disclaimer |
| Jinyi (Tianjin) Medical Technology Co., Ltd. | JY9501 | IFUExternal Link Disclaimer |
| Lanshan Shendun Technology Co., Ltd. | SD-KN95 | IFUExternal Link Disclaimer |
| Liaoning Dalian Jieying Energy Saving Environmental Protection Technology Development Co., Ltd. | JY-FH-F, JY-FH | JY-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., Ltd | FS9501-L, FS9501-M, FS9501-S; FS9901-L, FS9901-M, FS9901-S | IFUExternal Link Disclaimer |
| ORICH Medical Equipment (Tianjin) Co., Ltd. | N95 Folded Form (Non-sterile) | IFUExternal Link Disclaimer |
| PURIFA Medical Production Co., Ltd. | BU-E978 | IFUExternal Link Disclaimer |
| Putian Sisen Technology Co.,Ltd. | AIBANA 001 | IFUExternal Link Disclaimer |
| Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | IFUExternal Link Disclaimer |
| Qingdao Huaren Medical Product Co.,Ltd. | HRKFAM, HRKFBM | IFU |
| Qingdao Miuton Medical Co., Ltd | Stereoscopic type ear worn KN95 Protective Mask | IFUExternal Link Disclaimer |
| Qingzhou Yaowang Pharmaceutical Co., Ltd | N95-FWJ | IFUExternal Link Disclaimer |
| Quanding Medical Supplies Co., Ltd. | QD-FM004 | IFUExternal Link Disclaimer |
| Quanzhou Caier Paper Co., Ltd. | CC001 | |
| QUANZHOU LIGAO PROTECTIVE PRODUCT MANUFACTURER CO.,LTD | LG-DFM-01 | IFUExternal Link Disclaimer |
| Raxwell Industrial Technology (Shanghai) Co., Ltd | RX9501 | IFUExternal Link Disclaimer |
| Regina Miracle (Shenzhen) Ltd. | RM2020 MA-08 | |
| Rizhao Sanqi Medical & Health Articles Co., Ltd | RIZ100CVb, 3Q KN95, 3Q FFP2 NR, RIZQ100Sb, 3Q KN95 9505 | IFUExternal Link Disclaimer |
| Samding Craftwork Co., Ltd. | B13086 | IFUExternal Link Disclaimer |
| Shaanxi Hongji Pharmaceutical Co., Ltd. | HJF-E1 | IFUExternal Link Disclaimer |
| Shandong C.I.R.S. Garments Co., Ltd. | LSD008 | IFUExternal Link Disclaimer |
| Shandong Haidike Medical Products Co., Ltd. | N95-V1 | IFUExternal Link Disclaimer |
| Shandong Yuerong Network Technology Co., Ltd | Auben-0598 | |
| Shanghai Dasheng Health Products Manufacture Company, Ltd. | DTC3X-1, DTC3X-2, DTC3X-3, DTC3B-1 | DTC3X-1 IFUExternal Link DisclaimerDTC3X-2 IFUExternal Link DisclaimerDTC3X-3 IFUExternal Link DisclaimerDTC3B-1 IFUExternal Link Disclaimer |
| Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | IFUExternal Link Disclaimer |
| Shanghai Gangkai Purifying Products Co. Ltd. | 8022, 8012, 8013 | IFUExternal Link Disclaimer |
| Shanghai Homes Mask Co,ltd Company | HMS-801 | IFUExternal Link Disclaimer |
| Shanghai Tenry Pharmaceutical Co., Ltd. | TR-ZD01 | IFUExternal Link Disclaimer |
| Shanghai Yunqing Industrial Co., Ltd. | YQD95 KN95 | IFUExternal Link Disclaimer |
| Shangxian Minimal Invasive Inc. | CD9501 | IFUExternal Link Disclaimer |
| Shenyang Shengshi Medical Technology Co., Ltd. | Folding type SHI002 (non-sterile) | IFUExternal Link Disclaimer |
| Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd | FH | IFUExternal Link Disclaimer |
| Shenzhen SanheXing Stickers Products Co., Ltd. | SHX01 | IFUExternal Link Disclaimer |
| Shenzhen Yunyifu Health Technology Co., LTD. | PM-P2 | IFUExternal Link Disclaimer |
| SPRO Medical Products (Xiamen) Co., Ltd. | D918, GL001, GL001A | D918: IFUExternal Link DisclaimerGL001: IFUExternal Link DisclaimerGL001A: IFUExternal Link Disclaimer |
| Sure-On Industries Ltd | 210-KN95 | IFUExternal Link Disclaimer |
| Suzhou Bolisi Medical Technology Co., Ltd | BS-9501L, BS-9501FL, BS-9502C, BS-9502FC | |
| Suzhou Dongshan Precision Manufacturing Co., Ltd. | DKW00 | IFUExternal Link Disclaimer |
| Suzhou Sanical Protective Product Manufacturing Co., Ltd | 8015, 9015 | IFUExternal Link Disclaimer |
| Tengfei Tech. Co. Ltd. | TF-9006 | IFUExternal Link Disclaimer |
| Tianjin TEDA Filters Co., Ltd. | TEDA-P0652 | IFUExternal Link Disclaimer |
| Tongcheng Jiuxi Technology Co., Ltd. | JX-R950 | IFUExternal Link Disclaimer |
| UFI Filters (Shanghai) Co., Ltd. | 35.005 | |
| UHEALTH MEDICAL (BEIJING) PROTECTIVE PRODUCTS CO., LTD. | 0117 | IFUExternal Link Disclaimer |
| Violet Home Textile Technology Co., Ltd. | ZLL377 | IFUExternal Link Disclaimer |
| Weini Technology Development Co., Ltd | FFP2 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-220 | FFP2 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., LTD | WS-KZ-S4, WS-KZ-S4E | IFUExternal Link Disclaimer |
| Winner Medical Co., Ltd | WN-N95FW, WN-N95FGIN | IFUExternal Link Disclaimer |
| Wuhan Zonsen Medical Products Co., Ltd. | ZSFM-01, ZSFM-02 | ZSFM-01: IFUExternal Link DisclaimerZSFM-02: IFUExternal Link Disclaimer |
| Xiamen Chengchuang Automotive Materials Co., Ltd. | XPM2121 | IFUExternal Link Disclaimer |
| XIAMEN LIANYI INDUDSTIRAL & TRADING CO., LTD. | LY9501 | IFUExternal Link Disclaimer |
| XIAMEN PROBTAIN NONWOVEN INC. | MP9011 | IFUExternal Link Disclaimer |
| Xuan Cheng Zooboo Sports Goods Co., Ltd. | ZB008 | IFUExternal Link Disclaimer |
| Yangzhou Medline Industry Co., Ltd. | I 9501, II 9501 | I 9501: IFUExternal Link DisclaimerII 9501: IFUExternal Link Disclaimer |
| Yicheng Dunhou Medical Health Co., Ltd | DHA01 | IFUExternal Link Disclaimer |
| Yiyang Taihe Technology Co. Ltd | YTH0001 | |
| YuTong Eco-Technology (SuQian) Co., Ltd | YT-07 | IFUExternal Link Disclaimer |
| Zhangzhou Easepal Industrial Co., Ltd. | D13003 and D13003AC | IFUExternal Link Disclaimer |
| ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | IFUExternal Link Disclaimer |
| Zhejiang Dongmeng Medical Equipment Co., LTD | EYTV139110051-02 | |
| Zhejiang Langqi Fashion Co., Ltd | XJB902 | IFUExternal Link Disclaimer |
| ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | FM0201-966: IFUExternal Link Disclaimer |
| ZHEJIANG LUYAO ELECTRONICS TECHNOLOGY CO., LTD. | LY-N900-N909 | IFUExternal Link Disclaimer |
| ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | IFUExternal Link Disclaimer |
| ZHEJIANG SHUNFA SAFETY TECHNOLOGY CO., LTD | SF-K01, SF-K02 | IFUExternal Link Disclaimer |
| Zhejiang Yinda Biotechnology Co., Ltd. | YD-N2 | IFUExternal Link Disclaimer |
| Zhende Medical Co., Ltd. | N9501F | IFUExternal Link Disclaimer |
| Zhengzhou Ruipu Medical Technology Co. Ltd | KN95 | IFUExternal Link Disclaimer |
| Zhongkang Protective Equipment Technology (Guangzhou) Co., Ltd | ZK601; ZK626 | IFUExternal Link Disclaimer |
| Zhuhai HealthPro Medical Equipment Co., Ltd | HB202001-WH, HN202001 | HB202001-WH: IFUExternal Link DisclaimerHN202001: IFUExternal Link Disclaimer |
| ZIGONG WEIKANG MEDICAL EQUIPMENT CO., LTD | WJKZ-2 | IFUExternal Link Disclaimer |
| ZK-BEST (Xiamen) Environmental Science & Technology Co., Ltd. | ZKG9501, ZKG9501V | ZKG9501: IFUExternal Link DisclaimerZKG9501V: IFU |
~~~~ Chinese Mask Manufacturers FDA approved ~~~~
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