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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.

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
Model #: EcoGuard B ECO01

Surgical Mask - Disposable Single-Use 3-Ply Tie-on
Model #: EcoGuard B ECO02

Surgical Mask - Disposable Single-Use 4-Ply Earloop
Model #: EcoGuard A ECO03

Surgical Mask - Disposable Single-Use 4-Ply Tie-on
Model #: EcoGuard A ECO04

11/20/2020 Rymco Medical

Surgical Mask (Tie-On)
Model #: IMABEU

Surgical Mask (Earloop)
Model #: IMSBEU

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.


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). 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.

On October 15, 2020, the FDA reissued the Emergency Use Authorization (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. Effective immediately, 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 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: October 15, 2020)

The table below includes a list of non-NIOSH respirators authorized by this Umbrella EUA for emergency use during the COVID-19 public health emergency.

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. 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 Yianyuan 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: IFU
  • KN95 958, KN95 951: IFU
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. JYKN9501  
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
  • HB202001-WH: IFU
  • HN202001: IFU
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
  • FM0201-966: IFU
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 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.

Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR) (Updated November 25, 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 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
Grupo 10X SA DE CV d.b.a Sanitek Pro Sanitek Pro N95 Mexico
Rose Personal Protective Equipment Industry and Trade Anonym Company IRYS-08 Turkey
Brands Unlimited S.A. de C.V. Medimask MM-001 Mexico  
Hygiene Austria LP GmbH HA PP02 Austria  
Tenamyd Pharmaceutical Corporation Tenamyd FM-N95 Model YCKTC13 Vietnam  

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.

 

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