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  7. Personal Protective Equipment EUAs
  1. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

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

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.

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.

Manufacturer Authorized Product Name (including model numbers) Date of Addition
 --  --  --

N95 and Other Respirators EUAs (including EUAs for NISOH-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.


Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Reissued June 6, 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). As mentioned in CDC's strategies for optimizing respirator supply, other countries approve respirators according to country-specific standards. These devices are evaluated using methods similar to those used by NIOSH and are still expected to provide adequate protection for healthcare personnel. Non-NIOSH-approved FFRs manufactured in China that have been confirmed by FDA to meet the criteria under the EUA are included below in Appendix A.

As part of the government's continuous quality assessment of these respirators, the FDA, working with CDC NIOSH, conducted additional assessments and found 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 to among other revisions, revise the third criterion for eligibility. Additionally, the FDA, in collaboration with CDC NIOSH, is increasing surveillance and sampling of all respirators imported from China - all respirator shipments from China that come into the U.S. will be subject to random sampling and testing by CDC 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, to among other changes, further revise the third eligibility criterion, revise the second eligibility criterion, and remove decontaminated respirators from the scope of authorized products such that authorized respirators listed in Appendix A will no longer be authorized if they are decontaminated. Further explanation of the revisions can be found in the Frequently Asked Questions (FAQs) about Non-NIOSH-Approved Filtering Facepiece Respirators.

Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China (Updated: August 7, 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.

As stated in the EUA, 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.

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. 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 (PM 2.5) Protective Mask
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 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
  • 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9480V (FFP2): IFU
HANGZHOU FILTECH INTELLIGENT CO., LTD. Filtech Face Mask Model F860
HeiQ Materials AG HVB-FFP2-01  
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 (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 E-300, FFP2 NR E-680, FFP2 NR 952, FFP2 NR F-820: IFU
  • KN95 958, KN95 951: IFU
Xuan Cheng Zooboo Sports Goods Co., Ltd. ZB008
ZHEJIANG LILY UNDERWEAR CO.,LTD FM0201-966
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
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
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  
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  
NHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD JB-RP001  

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 Fujian Yongtai Sanlian Garment Co., Ltd. N95
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

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.

Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR) (Updated August 3, 2020)

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
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

Face Shields and Other Barrier EUAs

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.

 

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