Personal Protective Equipment EUAs
Personal Protective Equipment refers to protective clothing, helmets, gloves, face shields, goggles, respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness.
To help address concerns about availability during the COVID-19 pandemic, the FDA has issued EUAs for certain PPE products including face shields, other barriers, and respiratory protective devices such as respirators. Additionally, the FDA has issued recommendations and policies about PPE which can be found here: Recent Final Medical Device Guidance Documents.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including an Interactive Review Template For Non-IVD Products. Additionally, the FDA has posted a Surgical Masks EUA Template for Addition to Appendix A of the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
- Umbrella EUA for Surgical Masks
- N95 and Other Respirators EUAs
- Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs)
- Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs)
- Face Shields and Other Barrier EUAs
Umbrella EUA for Surgical Masks
On August 5, 2020, the FDA issued an umbrella emergency use authorization (EUA) for certain disposable, single-use surgical masks in response to concerns relating to insufficient supply and availability of such masks. This EUA authorizes the emergency use of surgical masks that meet certain performance requirements for use in healthcare settings by health care personnel as personal protective equipment to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic. Surgical masks that have been confirmed by FDA to meet the criteria under the EUA are included below in Appendix A as authorized surgical masks.
- EUA Letter of Authorization - Umbrella EUA for Surgical Masks
- Fact Sheet for Healthcare Personnel
- Appendix A: Authorized Surgical Masks
The Surgical Masks EUA Template for Addition to Appendix A can be used to provide the information requested in the EUA to the FDA.
Appendix A: Authorized Surgical Masks
The table below includes a list of surgical masks authorized by this Umbrella EUA for emergency use during the COVID-19 public health emergency.
Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
---|---|---|
08/08/2020 | Outdoor Research | Outdoor Research Surgical Mask model #OR2159 |
08/18/2020 | Venus Group, Inc. | Venus Medical Grade Disposable Surgical Mask |
09/19/2020 | Premier Guard USA LLC | Premier Guard USA Surgical Face Mask 20-1002-SFM3 |
10/05/2020 | Hanesbrands, Inc. | Hanes Surgical Mask 01, Small and Large |
10/08/2020 | WPT Corporation | WPT ASTM F2100-19 Level 3 Earloop Surgical Face Mask (Model # SMS2020) |
10/15/2020 | Premium-PPE Amerishield | Premium PPE Amerishield Disposable Surgical Mask Model #: PPE-M-AS-SUR-lvl2-S |
10/15/2020 | Brandix Apparel Solutions Limited | Disposable Surgical Mask BRNDX-DSM-001-LARGE |
10/28/2020 | SIO International Wisconsin, Inc. | Sharp MQ-3050 Surgical Mask Foxconn MQ-3050 Surgical Mask |
11/03/2020 | Fischer Manufacturing, LLC | Heartland Health Surgical Mask |
11/06/2020 | EcoGuard Inc. |
Surgical Mask - Disposable Single-Use 3-Ply Earloop Surgical Mask - Disposable Single-Use 3-Ply Tie-on Surgical Mask - Disposable Single-Use 4-Ply Earloop Surgical Mask - Disposable Single-Use 4-Ply Tie-on |
11/20/2020 | Rymco Medical |
Surgical Mask (Tie-On) Surgical Mask (Earloop) |
12/09/2020 | Nomad Goods | Nomad Surgical Mask N-MASK-3 |
12/10/2020 | Danameco Medical Joint Stock Corporation | D-Care Surgical Face Mask 3 ply (white), TAMMY Surgical Face Mask 3 ply (white) Model/AMIS Numbers: KTY60WK050, KTY75WK050, KTY74WK050 |
12/10/2020 | MOCACARE Corporation | MOCACARE Procedure Mask (Level 1) Model #: BC1003 |
12/16/2020 | Honeywell International Inc. | Procedure Mask with Earloops Model #: 559250M |
12/19/2020 | Honeywell International Inc. | Procedure Mask with Earloops Model #: 559250M B and 559250M C |
N95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
The table below includes information about respirators authorized for emergency use by healthcare personal during the COVID-19 public health emergency.
Date EUA Issued | PPE (Letter of Authorization) | Other Documents |
---|---|---|
03/28/2020 | NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency |
Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Reissued October 15, 2020)
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 Institutes of Occupational Safety and Health (NIOSH). Respirator models authorized by this EUA are listed in Appendix A and are 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 continuous 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 come into the U.S. are 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 includes the three eligibility criteria that were included in the previous June 6, 2020 authorization letter, meaning the FDA will no longer be reviewing requests and adding new respirator models to Appendix A based on those criteria. *Further explanation of the current EUA can be found in the Frequently Asked Questions (FAQs) about Non-NIOSH-Approved Filtering Facepiece Respirators.
- EUA Letter of Authorization - Umbrella EUA: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (Reissued October 15, 2020)
- Non-NIOSH Approved Disposable Filtering Facepiece Respirators Manufactured in China EUA FAQs
- Appendix A: Authorized Respirators, Non-NIOSH Respirators Manufactured in China (Updated October 15, 2020)
- Respirator Models No Longer Authorized (Updated October 15, 2020)
* Please note that the Appendix A list may be updated periodically to reflect administrative changes (for example, inclusion of a link to the instructions for use) or respirator model removal.
Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China (Updated with Administrative Changes or Respirator Model Removals: October 15, 2020.)
The table below includes a list of non-NIOSH-approved respirator models manufactured in China that are authorized by this Umbrella EUA for emergency use during the COVID-19 public health emergency.
As stated in the EUA, authorized respirators are 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) |
Respirator Models Removed from Appendix A (Respirator Models No Longer Authorized)
These respirator models had been on the list of authorized respirators in Appendix A but no longer meet the EUA eligibility criteria and thus are no longer authorized. Note: As outlined in the EUA, a respirator model with a removal date of May 7, 2020 is eligible for authorization under the revised third criterion if it has had particulate filtration efficiency assessed by NIOSH using a modified version of NIOSH's Standard Test Procedure (STP) TEB-APR-STP-0059 within 45 calendar days of May 7, 2020, and has results of NIOSH testing that indicate a minimum and maximum filtration efficiency greater than or equal to 95 percent. Respirators with removal dates after May 7, 2020 are not eligible for the revised third criterion. A respirator that meets the revised third criterion, or any of the other eligibility criteria in the EUA, is authorized and will be added to Appendix A as an authorized respirator once FDA confirms the eligibility criteria are met. 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) (Reissued June 6, 2020)
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 meet criteria as described in the EUA. Under this EUA, authorized respirators, which are listed in Exhibit 1, are authorized for use in healthcare settings by healthcare personnel 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, to further address the shortage of disposable FFRs, the FDA determined it was necessary to reissue the March 24, 2020 letter in order to amend the Scope of Authorization to additionally authorize the use of authorized respirators that have been decontaminated pursuant to the terms and conditions of an authorized decontamination system.
The FDA continues to be vigilant and take prompt action on imported, non-NIOSH approved respirators to ensure health care personnel receive adequate protection. On June 6, 2020, the FDA again revised this EUA to revise the scope concerning the decontamination of respirators with exhalation valves, and also revised the Scope of Authorization with respect to which jurisdictions are included in the second criterion for eligibility, among other revisions.
- EUA Letter of Authorization - Umbrella EUA Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (Reissued June 6, 2020)
- Exhibit 1: Authorized Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (Updated January 15, 2021)
Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR) (Updated January 15, 2021)
The table below includes a list of authorized non-NIOSH-approved disposable filtering facepiece respirators (FFRs) authorized under this Umbrella EUA for emergency use in healthcare settings by healthcare personnel (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 | 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 | Vietnam | |
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 |
Face Shields and Other Barrier EUAs
On May 1, 2020, the FDA issued an umbrella EUA for emergency use of protective barrier enclosures by healthcare providers (HCP) when caring for or performing medical procedures on patients who are known or suspected to have COVID-19 in healthcare settings to prevent HCP exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to personal protective equipment (PPE). The authorization of a device for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act, be revised or revoked when the criteria under section 564(b)(1) of the Act no longer exist, the criteria under section 564(c) of the Act for issuance of such authorization are no longer met, or other circumstances make such revision or revocation appropriate to protect the public health or safety.
On August 20, 2020, based on FDA's continued review of the scientific evidence available, the FDA has become aware of information that supports a determination to revoke the umbrella EUA on the grounds that the criteria under section 564(c) of the Act for issuance of an EUA are no longer met (see section 564(g)(2)(B)). Under section 564(c) of the Act, an EUA may be issued only if FDA concludes “that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that: (A) the product may be effective in diagnosing, treating, or preventing ---(i) such disease or condition […]; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product […].” In addition, FDA has determined that revocation is appropriate to protect the public health or safety (see section 564(g)(2)(C) of the Act), and that individualized consideration of each EUA request for protective barrier enclosures would better protect the public health.
Face shields and other barriers are a type of PPE intended to protect the user from bodily fluids, liquid splashes, or potentially infectious materials. Availability of certain PPE are an integral part of routine patient care during the COVID-19 pandemic. The table below includes authorization information about the use of authorized face shields and other barriers for use during the COVID-19 public health emergency.
Date EUA Issued | PPE (Letter of Authorization) | Other Documents |
---|---|---|
04/09/2020 | Face Shields |
|
05/08/2020 | Patient Isolation Transport Unit (PITU) Device | |
05/27/2020 | Gowns and Other Apparel |
|
06/13/2020 | Negative-pressure Respiratory System with Advanced Ventilation Return (NRSAVR-100) | |
05/19/2020 |
COVID-19 Airway Management Isolation Chamber (CAMIC) |
|
07/24/2020 | Airway Dome | |
09/24/2020 | COVIAGE | |
12/18/2020 | SCONE |
Additional Resources:
- N95 Respirators and Surgical Masks (Face Masks)
- Enforcement Policy guidance webinar
- FAQs on the EUAs for Non-NIOSH Approved Respirators During the COVID-19 Pandemic
- Face Masks and Surgical Masks for COVID-19: Manufacturing, Purchasing, Importing, and Donating Masks During the Public Health Emergency