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  1. Emergency Use Authorizations for Medical Devices

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:

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)

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).

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 Harley Commodity Company Limited L-103V KN95
Guangzhou Powecom Labor Insurance Supplies Co., LTD KN95


Haishi Hainuo Lexiang Medical Technology (Qingdao) Co., Ltd. LX1001  

Filtech Face Mask Model F860, F862, F890V, F891V, F890, F861


  • F860
  • F862
  • F890V
  • F891V
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
  • FFP2 NR E-300, FFP2 NR E-680, FFP2 NR 952, FFP2 NR F-820
  • KN95 958, KN95 951
Xuan Cheng Zooboo Sports Goods Co., Ltd. ZB008


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


Anhui Zhongke Duling Commercial Appliance Co. Ltd M-9501  
Dongguan Arun Industrial Co., LTD KN95 N9


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
  • 9560K
  • 9570K: IFU
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




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






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




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  


Huizhou Yibaidu Medical Device Technology Co., Ltd. YBD-2  


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




Anshun Health and Medical Technology Co., Ltd. AKF6002


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
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
  • 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




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




Zhuhai HealthPro Medical Equipment Co., Ltd HB202001-WH, HN202001
  • 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
  • ZKG9501
  • ZKG9501V
Guangxi MC Medical equipment Co., Ltd​ MC010501


Hunan EEXI Technology & Service Co., Ltd. YX152, YX153
  • 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
  • KN95-01
  • KN95-02
  • N1001
PURIFA Medical Production Co., Ltd. BU-E978


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
  • 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)
  • 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9480V (FFP2): IFU
  • 9980V (FFP3), 9920V (FFP3): IFU

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
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).

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
  • YCKTC13: IFU
  • YCTFA04: IFU
  • YCTFM02: IFU
  • YCTFA07: IFU
  • YCTMI08: IFU
  • YCTFM01: IFU
  • YCTFA06: IFU
  • YCTMI07: IFU
  • YCTMI02: IFU
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


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
  • MF-SG-N95-HH: IFU
  • MF-SG-N95-EH: IFU
Allix Co., Ltd. AM 200 South Korea  
Softmed Manufacturing Pty Ltd SM-RC201, SM-RF202 Australia
  • SM-RC201 
  • SM-RF202 
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


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