Revoked EUAs for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
FDA Revokes Emergency Use Authorizations for Non-NIOSH-Approved Disposable Respirators and Decontamination Systems as Access to FDA-authorized and NIOSH-approved N95s Increases Nationwide
On June 30, 2021, the FDA announced the revocation of the following EUAs:
- Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (effective July 6, 2021)
- Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (effective July 6, 2021)
- Decontamination and Bioburden Reduction System EUAs for Personal Protective Equipment (effective June 30, 2021)
As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings. For additional information, please see Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities.
Historical information regarding these EUAs can be found on Historical Information about Device Emergency Use Authorizations.
On this page:
- Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Revoked effective July 6, 2021))
- Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (Revoked effective July 6, 2021)
Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Revoked effective July 6, 2021)
On April 3, 2020, the FDA issued an umbrella EUA for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the National Institute for Occupational Safety and Health (NIOSH). Respirator models that were authorized by this EUA were listed in Appendix A and were authorized for emergency use by healthcare personnel in healthcare settings in accordance with CDC recommendations. Summaries of FDA's reissuances of this EUA follow.
As part of the federal government's quality assessment of these respirators, the FDA, working with CDC's NIOSH, conducted additional assessments and found that NIOSH's data indicated that some of the respirators authorized under the April 3, 2020 EUA did not meet the expected performance standards. In response, the FDA revised and reissued the EUA on May 7, 2020, including revising the third eligibility criterion such that all respirators that were previously authorized only under that criterion were no longer within the scope of authorization and were accordingly removed from Appendix A unless the respirator model was authorized under one of the remaining eligibility criterion in the May 7th letter. Additionally, the FDA, in collaboration with CDC's NIOSH, increased surveillance and sampling of all respirators imported from China. All respirator shipments from China that came into the U.S. were subject to random sampling and testing by CDC's NIOSH to determine whether the respirator meets the expected particulate filtration standards.
On June 6, 2020, the FDA further revised the Scope of Authorization of this EUA, including, among other changes, further revision to the eligibility criteria to provide additional specificity regarding the jurisdictions eligible for review and to remove decontaminated respirators from the scope of authorized products such that authorized respirator models listed in Appendix A are not authorized if they are decontaminated.
On October 15, 2020, the FDA reissued the EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators manufactured in China to authorize for emergency use only those respirators listed in the EUA's Appendix A as of the date of this reissuance. As of October 15, 2020, this EUA no longer included the three eligibility criteria that were included in the previous June 6, 2020 authorization letter, meaning the FDA no longer reviewed requests to add new respirator models to Appendix A based on those criteria as of October 15, 2020.
On June 30, 2021, the FDA announced the revocation of EUA (effective July 6, 2021).
- Revoked EUA Letter of Authorization - Umbrella EUA: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China
- Non-NIOSH Approved Disposable Filtering Facepiece Respirators Manufactured in China EUA FAQs
- Appendix A (Last Updated February 18, 2021; All models revoked effective July 6, 2021)
- Respirator Models Previously Removed from Appendix A (Last Updated October 15, 2020; All models revoked effective July 6, 2021)
Appendix A (Last Updated February 18, 2021; All models revoked effective July 6, 2021)
The table below includes a list of non-NIOSH-approved respirator models manufactured in China that were authorized at the time this Umbrella EUA was revoked.
These respirators were authorized for use by healthcare personnel in healthcare settings in accordance with the 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.
| Manufacturer | Respirator Model(s) | Instructions for Use |
|---|---|---|
| 3M | 9001, 9002, 9501, 9501+, 9501V+, 9502, 9502+, 9502V+, 9505+, 9541, 9541V, 9542, 9542V, 9552, 9552V | |
| Allmed Medical Products Co., Ltd | LP220002 | |
| AOK Tooling Ltd. (aka Shenzhonghai Medical) | 20130040, 20130045A, 20180021, 20130038, 20190019, 910, 20190029 | |
| Baoding Yinhong Yuhe Medical Device Manufacturing Co., Ltd. | YH/KN95-1 | |
| Bei Bei Safety Co Ltd. | B702, B702V, B704, B704V | |
| Beijing Topnew Import & Export Co., Ltd. | ZY95 | |
| BYD Precision Manufacture Co. Ltd. | DG3101, DN1102 | |
| Careable Biotechnology Co., Ltd. | CARE002, CARE003 | |
| Changsha Changjiu Medical Technology Co. Ltd. | KN95-05, KN95-08 | |
| Chengde Technology Co. | KN95 | |
| Creative Concepts Manufacturing Ltd. aka Huizhou RD Plastic Co., Ltd | 02676 | |
| Dongguan Sengtor Plastics Products Co., Ltd. | KN95 | |
| ESound Medical Device Co., Ltd. | 20182140615 Folded | |
| Fujian Leephick Pharmaceutical Industry Co. Ltd. | KPM-3 | |
| Fuzhou Chunlan Medical Equipment Co., Ltd. | CL-P1 | |
| Guangdong KINGFA SCI. & TECH. Co. Ltd. | KF-A F01, KF-A F10(SC) | |
| Guangdong Nuokang Medical Technology Co., Ltd. | KN95 Non-Surgical Disposable Particulate FFR | |
| GUANGZHOU BIOFIL AIR PURIFICATION MATERIALS CO.,LTD | MY3D2 | |
| Guangzhou Harley Commodity Company Limited | L-103V KN95 | |
| Guangzhou Powecom Labor Insurance Supplies Co., LTD | KN95 | |
| Haishi Hainuo Lexiang Medical Technology (Qingdao) Co., Ltd. | LX1001 | |
| HANGZHOU FILTECH INTELLIGENT CO., LTD. | Filtech Face Mask Model F860, F862, F890V, F891V, F890, F861
|
|
| Henan Bingzun Industrial Co.,Ltd. | 8410 | |
| Henan Yadu Industrial Co., Ltd | Flat Fold | |
| Hubei Huaqiang High-Tech Co., Ltd. | Flat Fold (Earloop) Non-Sterile | |
| Hunan Boltpower Guokang Medical Equipment Co., Ltd. | GK-002A | |
| Hunan Jianyuan Medical Science and Technology Co. Ltd. | JY009A | |
| Huizhou Huinuo Technology Co., Ltd | 9501A | |
| Jiande Chaomei Daily Chemicals Co. | F-Y3-A | |
| Jinwells (Tianjin) Science and Technology Co., Ltd. | JWS-1, JWS-2 |
|
| Lanshan Shendun Technology Co., Ltd. | SD-KN95 | |
| ORICH Medical Equipment (Tianjin) Co., Ltd. | N95 Folded Form (Non-sterile) | |
| Qingdao Huaren Medical Product Co.,Ltd. | HRKFAM, HRKFBM | |
| Qingdao Miuton Medical Co., Ltd | Stereoscopic type ear worn KN95 Protective Mask | |
| Qingzhou Yaowang Pharmaceutical Co., Ltd | N95-FWJ | |
| Raxwell Industrial Technology (Shanghai) Co., Ltd | RX9501 | |
| Rizhao Sanqi Medical & Health Articles Co., Ltd | RIZ100CVb, 3Q KN95, 3Q FFP2 NR, RIZQ100Sb, 3Q KN95 9505 | |
| Shaanxi Hongji Pharmaceutical Co., Ltd. | HJF-E1 | |
| Shandong Yuerong Network Technology Co., Ltd | Auben-0598 | |
| Shanghai Dasheng Health Products Manufacture Company, Ltd. | DTC3X-1, DTC3X-2, DTC3X-3, DTC3B-1 | |
| Shanghai Gangkai Purifying Products Co. Ltd. | 8022, 8012, 8013 | |
| Shanghai Tenry Pharmaceutical Co., Ltd. | TR-ZD01 | |
| Shanghai Yunqing Industrial Co., Ltd. | YQD95 KN95 | |
| Shenyang Shengshi Medical Technology Co., Ltd. | Folding type SHI002 (non-sterile) | |
| Shenzhen SanheXing Stickers Products Co., Ltd. | SHX01 | |
| Shenzhen Yunyifu Health Technology Co., LTD. | PM-P2 | |
| SPRO Medical Products (Xiamen) Co., Ltd. | D918, GL001, GL001A | |
| Sure-On Industries Ltd | 210-KN95 | |
| Suzhou Bolisi Medical Technology Co., Ltd | BS-9501L, BS-9501FL, BS-9502C, BS-9502FC | |
| Suzhou Sanical Protective Product Manufacturing Co., Ltd | 8015, 9015 | |
| Tengfei Tech. Co. Ltd. | TF-9006 | |
| UFI Filters (Shanghai) Co., Ltd. | 35.005 | |
| 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 |
|
| Xuan Cheng Zooboo Sports Goods Co., Ltd. | ZB008 | |
| ZHEJIANG LUYAO ELECTRONICS TECHNOLOGY CO., LTD. | LY-N900-N909 | |
| Zhende Medical Co., Ltd. | N9501F | |
| Chongqing Zisun (Zaisheng) Technology Corp., Ltd. | ZS-ZD-FJ-1, ZS-ZD-WJ-1 | |
| Guangdong Yidao Medical | YD-002 | |
| Shandong Haidike Medical Products Co., Ltd. | N95-V1 | |
| Shangxian Minimal Invasive Inc. | CD9501 | |
| Winner Medical Co., Ltd | WN-N95FW, WN-N95FGIN | |
| XIAMEN PROBTAIN NONWOVEN INC. | MP9011 | |
| Anhui Zhongke Duling Commercial Appliance Co. Ltd | M-9501 | |
| Dongguan Arun Industrial Co., LTD | KN95 N9 | |
| GUANGDONG GOLDEN LEAVES TECHNOLOGY DEVELOPMENT CO., LTD. | 8862 KN95 | |
| Guangdong Zhizhen Biological Medicine Co., Ltd. | KN95 Three-Dimensional Protective Face Mask | |
| Guangzhou Nan Qi Xing Non-Woven Co., Ltd. | KN-1 Respirator | |
| Guanyang Yunhan Textile Co., Ltd. | YH-9500 | |
| Huizhou Green Communication Equipment Manufacturing Co., Ltd | G95200 Particle Filtering Half Mask | |
| Jiangsu Yimao Filter Media Co., Ltd | 9570K, 9560K |
|
| Jinhua Jiadaifu Medical Supplies Co., Ltd. | Disposable Non-Medical Face Mask (KN95) | |
| Zhengzhou Ruipu Medical Technology Co. Ltd | KN95 | |
| Zhongkang Protective Equipment Technology (Guangzhou) Co., Ltd | ZK601; ZK626 | |
| Jiangsu Jiaao Medical Technology Co., Ltd. | JA95-1 Filtering half mask | |
| Liaoning Dalian Jieying Energy Saving Environmental Protection Technology Development Co., Ltd. | JY-FH-F, JY-FH |
|
| Yicheng Dunhou Medical Health Co., Ltd | DHA01 | |
| ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
| Hunan Kangweining Medical Devices Co., Ltd. | YH-I (non-sterile) and YH-II (sterile) | |
| Tianjin TEDA Filters Co., Ltd. | TEDA-P0652 | |
| Wilson Instruments (SHA) Co., LTD | WS-KZ-S4, WS-KZ-S4E | |
| Chongqing China Nano Technology Co., Ltd. | ZN6005 | |
| JIANGSU HOMCAN MEDICAL TECHNOLOGY CO. LTD | HC-NP95A | |
| GUANGDONG JINGCOS CO., LTD | 95J1 | |
| ZIGONG WEIKANG MEDICAL EQUIPMENT CO., LTD | WJKZ-2 | |
| Guangdong GangRong Medical Technology Co., Ltd | GR200 | |
| Anhui Hanxiutang Biotechnology Co., Ltd. | HXT-01 | |
| Hebei Pengyuan Optoelectronics Co., Ltd. | SUPERNOVA-P2 | |
| Guangdong Winsun Personal Care Products Co., Ltd. | YS0003 | |
| Guangzhou Carrot Mall Network Technologies Co., Ltd. | IRYS-01 | |
| Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd | FH | |
| Anhui Jinrui Auto Parts Co., Ltd. | JR-01 | |
| Yangzhou Medline Industry Co., Ltd. | I 9501, II 9501 | |
| Donghua Siecom Communication Technology Co.,Ltd | ZGKNM-01 | |
| ZHEJIANG SHUNFA SAFETY TECHNOLOGY CO., LTD | SF-K01, SF-K02 | |
| Tongcheng Jiuxi Technology Co., Ltd. | JX-R950 | |
| Hunan Changyuan Technology Co., Ltd. | CY005 Filtering Half Mask | |
| Putian Sisen Technology Co.,Ltd. | AIBANA 001 | |
| Samding Craftwork Co., Ltd. | B13086 | |
| JiangSu EverSmart Nano Technology Co., Ltd. | HZ-KN95 | |
| Guangdong Seyouse Technology and Culture CO,.LTD | SS-001 | |
| BG PRECISION CO. LTD | KN95-N | |
| Huizhou Yibaidu Medical Device Technology Co., Ltd. | YBD-2 | |
| XIAMEN LIANYI INDUDSTIRAL & TRADING CO., LTD. | LY9501 | |
| Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
| Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
| Xiamen Chengchuang Automotive Materials Co., Ltd. | XPM2121 | |
| Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
| Hangzhou Gang Yu Health Products Co., Ltd. | GY2020001 | |
| Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
| ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
| Anshun Health and Medical Technology Co., Ltd. | AKF6002 | |
| ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
| Meizhuangchen Health Technology (Shenzhen) Co., Ltd. | ENKN95-001 | |
| Jinyi (Tianjin) Medical Technology Co., Ltd. | JY9501 | |
| Heyuan COE Communication Technology Co., Ltd. | CHMM-NB | |
| Jinhua Ai Kou Protective Equipment Co., | AK003 | |
| Jiangmen Nostop Electric Co., Ltd | JW-017 | |
| YuTong Eco-Technology (SuQian) Co., Ltd | YT-07 | |
| Dongguan City Outdoorsy Co., Ltd. | OD-001 | |
| Guangdong Tengrui Pharmaceutical Technology Co., Ltd. | LSH-201 | |
| Hunan Hengchang Pharmaceutical Co., LTD. | N9501-L (non-sterile type) | |
| AnDum Protective Equipment Technology (Changzhou) Co.,Ltd. | AD-1001 | |
| Beifa Anhui Manufacturing Co., Ltd. | BF-A-01 | |
| Guangzhou Bofeite Safety Protective Supplies Co., Ltd. | HT9510V, HT9510 | |
| Quanzhou Caier Paper Co., Ltd. | CC001 | |
| Shandong C.I.R.S. Garments Co., Ltd. | LSD008 | |
| Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | |
| UHEALTH MEDICAL (BEIJING) PROTECTIVE PRODUCTS CO., LTD. | 0117 | |
| Yiyang Taihe Technology Co. Ltd | YTH0001 | |
| Zhangzhou Easepal Industrial Co., Ltd. | D13003 and D13003AC | |
| Zhejiang Langqi Fashion Co., Ltd | XJB902 | |
| Zhejiang Yinda Biotechnology Co., Ltd. | YD-N2 | |
| Fujian Yongtai Sanlian Garment Co., Ltd. | N95 Particulate Respirator (Xier) | |
| Hui Zhou Tian Chang Industrial Co., Ltd. | N002-AW | |
| Jingzhou Strong Sciences & Technology Development Co.,ltd | ST-A9502, A9507 |
|
| Lu'an Bi Hai Protective Equipment Co., Ltd. | BH2020 | |
| Naton Medical Protective Mask (Zhuozhou) Co., Ltd | FS9501-L, FS9501-M, FS9501-S; FS9901-L, FS9901-M, FS9901-S | |
| Deli Group Co., LTD. | ET30000 | |
| DONGGUAN AOXING AUDIO VISUAL EQUIPMENT CO.,LTD | AX-KF95 | |
| Guangdong Languan Medical Biotechnology Co., Ltd. | LGKN95 | |
| Wuhan Zonsen Medical Products Co., Ltd. | ZSFM-01, ZSFM-02 | |
| Zhejiang Dongmeng Medical Equipment Co., LTD | EYTV139110051-02 | |
| Regina Miracle (Shenzhen) Ltd. | RM2020 MA-08 | |
| Violet Home Textile Technology Co., Ltd. | ZLL377 | |
| Guangdong Willing Technology Corporation | WL-01 | |
| Changshu Dayi Health Protection Articles Co., Ltd | DY-3 | |
| Shanghai Homes Mask Co,ltd Company | HMS-801 | |
| FOSHAN FLOCON MEDICAL EQUIPMENTS CO., LTD | M1 | |
| JIANGSU CHANGMEI MEDTECH CO.,LTD | DFM-01 | |
| QUANZHOU LIGAO PROTECTIVE PRODUCT MANUFACTURER CO.,LTD | LG-DFM-01 | |
| Zhuhai HealthPro Medical Equipment Co., Ltd | HB202001-WH, HN202001 |
|
| Fujian Yifa Healthcare Products Co., Ltd. | Y195 | |
| Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
| ZK-BEST (Xiamen) Environmental Science & Technology Co., Ltd. | ZKG9501, ZKG9501V |
|
| Guangxi MC Medical equipment Co., Ltd | MC010501 | |
| Hunan EEXI Technology & Service Co., Ltd. | YX152, YX153 |
|
| Suzhou Dongshan Precision Manufacturing Co., Ltd. | DKW00 | |
| Carte Medical Equipment (Suzhou) Co., Ltd | K8201 | |
| Dongguan Pan American Electronics Co., Ltd. | KN95-01, KN95-02, N1001 |
|
| PURIFA Medical Production Co., Ltd. | BU-E978 | |
| WENZHOU KADIBANG GARMENTS CO., LTD. | KBD-M01 | |
| Jiangsu Sanfo Outdoor Products Co., Ltd | CX9501-P | |
| Jiaxing Yinuo Busway Co., Ltd. | YJ-P2 | |
| Fujian Dahong Industrial Development Co. Ltd. | PGT-0095 | |
| ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 |
|
| Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
| Hangzhou San Qiang Safety Protection Products Co., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
|
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Respirator Models Previously Removed from Appendix A (Last Updated October 15, 2020; All models revoked effective July 6, 2021)
These respirator models had been on the list of authorized respirators in Appendix A but no longer met the EUA eligibility criteria and thus were no longer authorized. Results from NIOSH's testing are provided at: https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html
| Date No longer Authorized | Manufacturer | Respirator Model(s) No Longer Authorized |
|---|---|---|
| 05/07/2020 | AAB (China) Co., Ltd | KN95 |
| 05/07/2020 | Anshun Health and Medical Technology Co., LTD | AKF2002 |
| 05/07/2020 | Bei (Dong Shan) Protective Supplies Co., LTD | B707 |
| 05/07/2020 | Changsha JNEYL Medical Equipment Co., Ltd | JN-9501 |
| 05/07/2020 | Changzhou Wedream Medical Device Co., Ltd | KN95 |
| 05/07/2020 | Chongqing China Nano Technology Co., Ltd | ZN8005 |
| 05/07/2020 | Chongqing Zaisheng Technology Co., Ltd. | ZS-A950 |
| 05/07/2020 | Chuzhou Qiao Dong Industrial Co., Ltd | Langie KN95 FFP2 |
| 05/07/2020 | Creative Concepts Manufacturing Ltd | 02669, KN95 |
| 05/07/2020 | CTT CO. Ltd. | KN95 |
| 05/07/2020 | Daddybaby Co. Ltd. | KN95 FFP2 |
| 05/07/2020 | DongGuan HuaGang Communication Technology Co., Ltd | KN95-A; KN95-B |
| 05/07/2020 | Dongguan Leihuo Medical Device Co., LTD | CPFM-100, CPFM-101, LH-KN95 |
| 05/07/2020 | Dongguan Xianda Medical Equipment Co., Ltd | KN95 |
| 05/07/2020 | Foshan Nanhai Weijian Sanbang Protective Equipment Technology Co., Ltd | KN95 Model 9051A |
| 05/07/2020 | Fujian Pageone Garment Co., Ltd | KN95 |
| 05/07/2020 | Guangdong Fei Fan MStar Technology Ltd | KN95 |
| 05/07/2020 | Guangdong Kaper Protection Technology Co., Ltd | KP-K02 (N95) |
| 05/07/2020 | Guangzhou Aiyinmei Co., LTD | A&F KN95 |
| 05/07/2020 | Guangzhou Sunjoy Auto Supplies Co., LTD | Earhook folding type K1-K100, Headband folding type K1-K100 |
| 05/07/2020 | Guangzhou Yihere Medical Technology Development Co., Ltd | YH-MFK-B95, YH-MFK-Z95 |
| 05/07/2020 | Guizhou Bocai Medical Device Co., Ltd. | Bocai KN95 |
| 05/07/2020 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
| 05/07/2020 | Henan Youmaisi Health Technology Co. LTD | YMS-AN95 |
| 05/07/2020 | Huizhou Huinuo Technology Co., LTD | HV-N White 9501B |
| 05/07/2020 | Huizhou Jiahe Cubic Technology Co., LTD | KN95 |
| 05/07/2020 | Huizhou Lexuslance Technology Co. Ltd. | LK 003 |
| 05/07/2020 | Improve Medical (Hunan) Co., Ltd. | PPDS Disposable Protective Respirator Strap Headband, PPDS Disposable Protective Respirator Ear Hook |
| 05/07/2020 | Jiangsu Weichuangli New Materials Co., Ltd. | WCL-0075 |
| 05/07/2020 | Jiangxi Hornet Industrial Co. Ltd. | S-KN95 |
| 05/07/2020 | Jiangxi Yifengyuan Biological Engineering Co., Ltd. | N95, KN95 |
| 05/07/2020 | Jinan Vhold Co., LTD | VH-95 |
| 05/07/2020 | Juntech (Jiaxing) Healthcare Materials Co. Ltd | KN95 |
| 05/07/2020 | Panzhihua Gangcheng Group Yasheng Industrial Co., Ltd. | KN95 |
| 05/07/2020 | Qingdao Orphila Medical Technology Co. LTD. | OM-KN95-FFP2 |
| 05/07/2020 | Qingyuan Leite Technology Development Co. | GV-0095A, GVHKN95 |
| 05/07/2020 | Shandong Daddy's Choice Health Science and Technology Co., Ltd | Purism KN95 |
| 05/07/2020 | Shandong Huishoutang Pharmaceutical Co | KN95 |
| 05/07/2020 | Shandong Shengquan New Material Co., Ltd | SNN70370B (Willow leaf form valveless) |
| 05/07/2020 | Shauguan Taijie Protection Technology Co. Ltd. | KN95 |
| 05/07/2020 | Shenzhen Horb Technology Corp., Ltd | 1.7.02.02.0001 |
| 05/07/2020 | Shenzhen Missadola Technology Co., Ltd, dba 1AK Medical Supplies | 2626-1 KN95 |
| 05/07/2020 | Sunright Medical Technology (GuangDong) Co., LTD | KN95-C3 |
| 05/07/2020 | Tianjin Benmo Medical Equipment Co., Ltd. | KN95 |
| 05/07/2020 | Winner Medical Co. Ltd. | WN-N95FG |
| 05/07/2020 | Yiwu Henghao household products Co., Ltd | HH-KN95-001 |
| 05/07/2020 | Yiwu Yifan Knitting Co. Ltd | KN95 |
| 05/07/2020 | Zhangzhou Easepal Industrial Corp. | MASK-104 |
| 05/07/2020 | Zhejiang Baiyi Intelligent Garment Co LTD | KN95 |
| 05/07/2020 | Zhejiang Shengtai Baby Products Co Ltd | KN95 |
| 05/07/2020 | Zhengzhou QBS New Material Co., LTD | KN95 |
| 05/07/2020 | Zhengzhou Wanshenshan Healthcare PPE Co., Ltd. | KN95 |
| 06/06/2020 | Fujian Kang Chen Daily Necessities Co, Ltd. | K0450, 57793 |
| 10/15/2020 | HeiQ Materials AG | HVB-FFP2-01 |
Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (Revoked effective July 6, 2021)
On March 24, 2020, the FDA issued an umbrella EUA for certain imported disposable filtering facepiece respirators (FFRs) that are not approved by the National Institute for Occupational Safety and Health (NIOSH) and that met eligibility criteria as described in the EUA. Under this EUA, respirators, listed in Exhibit 1, were authorized for use in healthcare settings by healthcare personnel (HCP) when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the Coronavirus Disease 2019 (COVID-19) outbreak.
On March 28, 2020, FDA revised this EUA to authorize the use of certain authorized respirators that have been decontaminated pursuant to the terms and conditions of an authorized decontamination system.
On June 6, 2020, FDA again revised the EUA to exclude decontaminated respirators with exhalation valves from the scope of authorization, as well as to add additional specificity regarding which jurisdictions were included in the second criterion for eligibility.
On March 24, 2021, the FDA revised this EUA to authorize for emergency use only those respirators listed in the EUA's Exhibit 1 as of the date of this reissuance. The FDA no longer reviewed requests to add new respirator models to Exhibit 1 of this EUA after March 24, 2021.
On June 30, 2021, the FDA announced the revocation of EUA (effective July 6, 2021).
- Revoked EUA Letter of Authorization - Umbrella EUA Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
- Exhibit 1 (Last Updated March 8, 2021; All models revoked effective July 6, 2021)
Exhibit 1 (Last Updated March 8, 2021; All models revoked effective July 6, 2021)
The table below includes a list of non-NIOSH-approved disposable FFRs that were authorized under this Umbrella EUA for emergency use in healthcare settings by HCP when used in accordance with CDC recommendations. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage: Strategies for Optimizing the Supply of N95 Respirators.
| Manufacturer | Respirator Model(s) | Country of Manufacture | Instructions for Use |
|---|---|---|---|
| 3M | 8205 | Japan | |
| 3M | 8822 | South Korea | |
| 3M | 9320+ | UK, Singapore, Turkey | |
| 3M | 9322+ | UK, Singapore, Turkey | |
| Dromex | Model 1020 | South Africa | |
| Ap Mascarillas S.A. de C.V. | AP M10, AP Z6 | Mexico | |
| BTL Industries | FLAT-FIT Healthcare Respirator | Bulgaria | |
| Plastcor Do Brasil LTDA | ECHO PFF2 CA 38.811 | Brazil | |
| Galia Textil S.A. DE C.V | GTN95 | Mexico | |
| Novita, 9 Koi Marketing Pte Ltd | R5, R7 | Singapore | |
| Rose Personal Protective Equipment Industry and Trade Anonym Company | IRYS-08 | Turkey | |
| Brands Unlimited S.A. de C.V. | Medimask MM-001, MM-002, MM-003 A, MM-003 B, MM-003 C, MM-003 D, MM-003 E, MM-003 F, MM-003 G, MM-003 H, MM-003 I, MM-003 J, MM-003 K, MM-003 L, MM-004 A, MM-004 B, MM-004 C, MM-004 D, MM-004 E, MM-004 F, MM-004 G, MM-004 H, MM-004 I, MM-004 J, MM-004 K, and MM-004 L | Mexico | |
| Hygiene Austria LP GmbH | HA PP02 | Austria | |
| Tenamyd Pharmaceutical Corporation | Tenamyd FM-N95 Model YCKTC13, Tenafa® N-95 Model YCTFA04, Tenami® N-95 Model YCTM102, YCTFM02, YCTFA07, YCTMI08, YCTFM01, YCTFA06, YCTMI07 | Vietnam |
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| Lanaco Limited | WAIRE P2 | New Zealand | |
| Keeo Life Private Limited | KF-SG-N95-HL, KF-SG-N95-EL | India | |
| MUSK Medikal Tekstil Plastik Sanayi Ve Ticaret Limited Sirketi | MUSK001 | Turkey | |
| Grupo 10X SA DE CV d.b.a Sanitek Pro | Sanitek Pro N95 | Mexico | |
| Advanced Medical Devices Pty Limited | Nano-Tech P2 Particulate Respirator - T4 | Australia | |
| Alumitek Ingenieria S de RL de CV | MXN95R1 | Mexico | |
| MY ARLET | ARLET 5000 FFP2 NR, ARLET 6000 FFP3 NR | Turkey | |
| Productos Químicos y Farmacéuticos R&M S.A de C.V. | PLB 95 | Mexico | |
| Evolve Group Pty Ltd | IPKIS P2 Respirator | Australia | |
| Mkteks Mensucat Tekstil Sanayi VE Ticaret Limited Sirketi | WV NR 101 | Turkey | |
| GCE Lighting / Savoy International | MRP-FFP2-AM-20 | France | |
| Macopharma | F2001N | France | |
| Hwa Yui Co., Ltd | HY20 | South Korea | |
| Care Essentials Pty Ltd | MSK-001, MSK-001S, MSK-002, MSK-002S | Australia | |
| Best Pacific Vietnam Company Limited | MASK-VN-22 | Vietnam | |
| Rang Company | MB100 | South Korea | |
| Manohar Filaments Private Limited | MF-SG-N95-HH, MF-SG-N95-EH | India | |
| TRN MODA TEKSTIL SAN VE TIC LTD STI | O2BLS-NRFM002, O2BLS-NRFM003 | Turkey | |
| Allix Co., Ltd. | AM 200 | South Korea | |
| Softmed Manufacturing Pty Ltd | SM-RC201, SM-RF202 | Australia |
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| NTI Vina Co. Ltd. | SG9010V | Vietnam | |
| BioSerenity | 1016-07003-US | France | |
| Sonata Calcetin S.A. de C.V. | CB01 | Mexico | |
| Layfield Canada Ltd. | 1970EU | Canada |