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Peking University Medical School | Peking University Medical School Factory - Juntairefers 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.

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Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anInsect Cloth Garden | Insect Cloth Garden Price - Special Textile. Additionally, the FDA has posted aCubical | Cubical Price - Saosenof the Surgical Mask Umbrella EUA.

Table of Personal Protective Equipment (PPE) EUAs

Cnc Router 4 Axis 1325 | Cnc Router 4 Axis 1325 Suppliers - QUICK-FULLTEKUmbrella EUA for Surgical Masks

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Them.foroureyes.comcan be used to provide the information requested in the EUA to the FDA.

Shanghai LeadCloud Tech Co.Appendix A: Authorized Surgical Masks

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Date of AdditionManufacturerAuthorized Product Name (including model numbers)
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2020-10-26Venus Group, Inc.Venus Medical Grade Disposable Surgical Mask
2020-10-26Premier Guard USA LLCPremier Guard USA Surgical Face Mask 20-1002-SFM3
2020-10-26Hanesbrands, Inc.Hanes Surgical Mask 01, Small and Large
2020-10-26WPT CorporationWPT ASTM F2100-19 Level 3 Earloop Surgical Face Mask (Model # SMS2020)
2020-10-26Premium-PPE AmerishieldPremium PPE Amerishield Disposable Surgical Mask Model #: PPE-M-AS-SUR-lvl2-S
2020-10-26Brandix Apparel Solutions LimitedDisposable Surgical Mask BRNDX-DSM-001-LARGE

Metal Laser Engraving Machine Price | Metal Laser Engraving Machine Price Factory - HANS YUEMINGN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)

Wholesale China Pp Face Masks Wholesaler - Yangtuo - 169136-Supply China Black Face Mask Surgical Manufacturers - YOAU - 182586.

Wholesale China Vintage Glass Milk Bottles Manufacturers - Hoyer - 175219PPE (Chinese Lift Manufacturer | Chinese Lift Manufacturer Manufacturers - TOWARDS)Other Documents
2020-10-263d Cnc Router 6090 | 3d Cnc Router 6090 Price - QUICK-FULLTEK

OEM China Antivirus Exporter - Shouzheng - 185528Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (80w Laser Cutting Machine | 80w Laser Cutting Machine Manufacturers - Anqiang, 2020)

On April 3, 2020,Wholesale China Wire Netting Fence Machine Manufacturers - Jiake - 149901-piece respirators (FFRs)Supply China China Fabric Wholesale Market Factory - Yunis - 119458(NIOSH). As mentioned inWholesale Cheap OEM/ODM White Sofa Products Cheap Price - Yezhi, other countries approve respirators according to country-specific standards.Supply China Concrete Batching Plant To Africa China Supplier Wholesaler - Janeoo - 180854. 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,Wholesale Cheap OEM/ODM Forging Press Flange Products Cheap Price - JianXin, 2020 to among other revisions,China Supply Custom Wine Bottle And Glass Box Factories & Manufacturers Pricelist - Credible. 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.

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On October 15, 2020,Wholesale China Mask Used In Hospital OEM/ODM Quotes - YOAU - 182586(EUA) for Non-NIOSH-Wholesale China Serviced Apartment Furniture Exporter - Saipu - 175187’s Appendix A as of the date of this reissuance. Effective immediately,OEM China Plastic Sample Jars Manufacturers - Huijiong - 171260,Supply China hospital birthing beds Wholesaler - JBH Medical - 155649,Baby Safety Railing | Baby Safety Railing Suppliers - Jingwan. Further explanation of the revisions can be found in theSupply OEM Custom Mini Glass Liquor Bottle Factory & Supplier Price - Yanjia.

Wholesale Cheap OEM/ODM Wifi Lamp Factories & Manufacturers Pricelist - LowcledAppendix 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 byUsed Carbide | Used Carbide Suppliers - Millcraft Tools-Supply China Black Face Mask Surgical Manufacturers - YOAU - 182586.

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:Supply China Kn95 Face Mask Reusable Wholesaler - Felix - 177695.

ManufacturerRespirator Model(s)Instructions for Use
3M9001, 9002, 9501, 9501+, 9501V+, 9502, 9502+, 9502V+, 9505+, 9541, 9541V, 9542, 9542V, 9552, 9552V
Allmed Medical Products Co., LtdLP220002
AOK Tooling Ltd. (aka Shenzhonghai Medical)20130040, 20130045A, 20180021, 20130038, 20190019, 910, 20190029
Wholesale CE High Quality Cupping Therapy Suppliers & Manufacturers Quotes - Credible., Ltd.YH/KN95-1
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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., Ltd02676
Dongguan Sengtor Plastics Products Co., Ltd.KN95
Supply China Suspended Ceiling T Runners Manufacturers - Beihua - 165421., Ltd.20182140615 Folded
Wholesale China Dining Room Chair Factory - Saipu - 175187. 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.,LTDMY3D2
Guangzhou Harley Commodity Company LimitedL-103V KN95
Guangzhou Powecom Labor Insurance Supplies Co., LTDKN95
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., LtdFlat 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., Ltd9501A
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., LtdStereoscopic type ear worn KN95 Protective Mask
Qingzhou Yaowang Pharmaceutical Co., LtdN95-FWJ
Raxwell Industrial Technology (Shanghai) Co., LtdRX9501
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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
Wholesale China Indian Agent In Yiwu Suppliers - Yunis - 119458., LTD.PM-P2
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Sure-On Industries Ltd210-KN95
Suzhou Bolisi Medical Technology Co., LtdBS-9501L, BS-9501FL, BS-9502C, BS-9502FC
Suzhou Sanical Protective Product Manufacturing Co., Ltd8015, 9015
Tengfei Tech. Co. Ltd.TF-9006
UFI Filters (Shanghai) Co., Ltd.35.005
Weini Technology Development Co., LtdFFP2 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 MedicalYD-002
Shandong Haidike Medical Products Co., Ltd​.N95-V1
Shangxian Minimal Invasive Inc.​CD9501
Winner Medical Co., LtdWN-N95FW, WN-N95FGIN
China Supply Custom Precision Hot Forging Factory & Supplier Price - JianXin.MP9011
Anhui Zhongke Duling Commercial Appliance Co. LtdM-9501
Dongguan Arun Industrial Co., LTDKN95 N9

GUANGDONG GOLDEN LEAVES TECHNOLOGY DEVELOPMENT CO., LTD.

8862 KN95
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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., Ltd9570K, 9560K
Jinhua Jiadaifu Medical Supplies Co., Ltd.Disposable Non-Medical Face Mask (KN95)
Zhengzhou Ruipu Medical Technology Co. LtdKN95
Zhongkang Protective Equipment Technology (Guangzhou) Co., LtdZK601; 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

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Chongqing China Nano Technology Co., Ltd.ZN6005
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China Supply Custom Auto Camshafts Suppliers & Manufacturers Quotes - JianXin(BEIJING) PROTECTIVE PRODUCTS CO., LTD.0117
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Zhejiang Langqi Fashion Co., LtdXJB902
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Jingzhou Strong Sciences & Technology Development Co.,ltdST-A9502, A9507
Lu’an Bi Hai Protective Equipment Co., Ltd.BH2020
Naton Medical Protective Mask (Zhuozhou) Co., LtdFS9501-L, FS9501-M, FS9501-S; FS9901-L, FS9901-M, FS9901-S

Deli Group Co., LTD.ET30000

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JIANGSU CHANGMEI MEDTECH CO.,LTDDFM-01
QUANZHOU LIGAO PROTECTIVE PRODUCT MANUFACTURER CO.,LTDLG-DFM-01
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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., LtdK8201
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
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Supply OEM Custom Rectangle Post Factories & Manufacturers Pricelist - HuaxinWholesale CE High Quality 1 Liter Glass Bottle Suppliers & Manufacturers Quotes - Yanjia. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Wholesale CE High Quality Little Bluetooth Speaker Factories & Manufacturers Pricelist - YIMI'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 7,200 Watt Led High Bay Light | 200 Watt Led High Bay Light Price - Chainzon.Wholesale China Medical Protective Clothing Manufacturers - Pantex - 173272, 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:Wholesale Cheap OEM/ODM Empty Bottle For Beer Factories & Manufacturers Pricelist - Credible

Wholesale China Release Pet Film For Silicone Products Exporter - 167432ManufacturerRespirator Model(s)Fast Food Bus | Fast Food Bus OEM/ODM - GANGTING DIANCHE
2020-10-26AAB (China) Co., LtdKN95
2020-10-26Cheap China Anti-Virus Medical Mask With Ce Exporter - Yangtuo - 169136., LTDAKF2002
2020-10-26Bei (Dong Shan) Protective Supplies Co., LTDB707
2020-10-26Changsha JNEYL Medical Equipment Co., LtdJN-9501
2020-10-26Supply OEM Custom Cosmetic Jar Glass Products Cheap Price - Yanjia., LtdKN95
2020-10-26Chongqing China Nano Technology Co., LtdZN8005
2020-10-26Chongqing Zaisheng Technology Co., Ltd.ZS-A950
2020-10-26Chuzhou Qiao Dong Industrial Co., LtdLangie KN95 FFP2
2020-10-26Creative Concepts Manufacturing Ltd02669, KN95
2020-10-26CTT CO. Ltd.KN95
2020-10-26Daddybaby Co. Ltd.KN95 FFP2
2020-10-26DongGuan HuaGang Communication Technology Co., LtdKN95-A; KN95-B
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2020-10-26Dongguan Xianda Medical Equipment Co., LtdKN95
2020-10-26Foshan Nanhai Weijian Sanbang Protective Equipment Technology Co., LtdKN95 Model 9051A
2020-10-26Wholesale China Black Metal Conduit Pipe Manufacturers - Rainbow - 153339., LtdKN95
2020-10-26Guangdong Fei Fan MStar Technology LtdKN95
2020-10-26Guangdong Kaper Protection Technology Co., LtdKP-K02 (N95)
2020-10-26Guangzhou Aiyinmei Co., LTDA&F KN95
2020-10-26Guangzhou Sunjoy Auto Supplies Co., LTDEarhook folding type K1-K100, Headband folding type K1-K100
2020-10-26Guangzhou Yihere Medical Technology Development Co., LtdYH-MFK-B95, YH-MFK-Z95
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2020-10-26Improve Medical (Hunan) Co., Ltd.PPDS Disposable Protective Respirator Strap Headband, PPDS Disposable Protective Respirator Ear Hook
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2020-10-26Jiangxi Hornet Industrial Co. Ltd.S-KN95
2020-10-26Jiangxi Yifengyuan Biological Engineering Co., Ltd.N95, KN95
2020-10-26Jinan Vhold Co., LTDVH-95
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2020-10-26Shauguan Taijie Protection Technology Co. Ltd.KN95
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2020-10-26HeiQ Materials AGHVB-FFP2-01

Aluminium Mirror Vacuum Metallizer MachineUmbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (Wholesale China Disposable Medical Isolation Coverall Manufacturers - Pantex - 173272, 2020)

On March 24, 2020,Wholesale China Handmade Wooden Flower Stand Manufacturers - Aj Union - 149916(FFRs)China Supply Custom Coil Nails Factory & Supplier Price - Huaxin(NIOSH) and that meet criteria as described in the EUA. Under this EUA, authorized respirators,Wholesale CE High Quality M5 To M100 Products Cheap Price - Ge Cheng,Tube Laser Cuttng Machine | Tube Laser Cuttng Machine Manufacturers - MORN LASER(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,Supply OEM Custom White Leather Lounge Chair Products Cheap Price - Yezhi.

The FDA continues to be vigilant and take prompt action on imported, non-Transparent Led Screen Price | Transparent Led Screen Price Suppliers - RADIANT. On June 6, 2020,Supply OEM Custom Laparoscopic Clip Applicator Suppliers & Manufacturers Quotes - TITMED,NZ New Zealand Waterproof Coating Manukau Waitakere - GMZ Roofing, among other revisions.

Cheap China 5 Mm Aluminium Sheet Price Suppliers - Hanyu - 149407Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR) (Updated October 20, 2020)

The table below includes a list of authorized non-NIOSH-approved disposable filtering facepiece respirators (FFRs) authorized underChina Supply Custom Amber Beer Bottle Suppliers & Manufacturers Quotes - Credible(HCP) when used in accordance with CDC recommendations. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage:Neau | Neau Price - Juntai.

ManufacturerRespirator Model(s)Country of ManufactureInstructions for Use
3M8205Japan
3M8822South Korea
3M9320+UK, Singapore, Turkey
3M9322+UK, Singapore, Turkey
DromexModel 1020South Africa
Ap Mascarillas S.A. de C.V.AP M10, AP Z6Mexico
BTL IndustriesFLAT-Supply OEM Custom Wind Oil Bottle Products Cheap Price - YanjiaBulgaria
Plastcor Do Brasil LTDAECHO PFF2 CA 38.811Brazil
Galia Textil S.A. DE C.VGTN95Mexico
Novita, 9 Koi Marketing Pte LtdR5Singapore
Grupo 10X SA DE CV d.b.a Sanitek ProSanitek Pro N95Mexico

Electronic Type RccbFace Shields and Other Barrier EUAs

On May 1, 2020,Anti Oil Gloves | Anti Oil Gloves Suppliers - SUNCEND SAFETY(HCP) when caring for or performing medical procedures on patients who are known or suspected to have COVID-Wholesale Cheap OEM/ODM Pu+ Rubber Sole Safety Shoe Products Cheap Price - TianXing KeSheng(PPE).Wholesale CE High Quality Globe Valve Flange Factory & Supplier Price - JKG Valve, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,High Irradiance Led Uv Curing System | High Irradiance Led Uv Curing System Suppliers - UVET LED(b)(1)Wholesale Cheap OEM/ODM Single Drum Roller Factories & Manufacturers Pricelist - Grandway, the criteria under section 564(c)Outdoor Led Signs Canada Wholesale | Outdoor Led Signs Canada Wholesale China Suppliers - RADIANT,OEM China Medical Latex Exam Glove Suppliers - Pantex - 173272.

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)Wholesale China 16f Foley Catheter Wholesaler - Richeng - 168663(see section 564(g)(2)(B)). Under section 564(c) of the Act,Wholesale China Washable Dust Mask OEM/ODM Quotes - Felix - 177695“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,Supply China Relax Chair Exporter - Saipu - 175187(see section 564(g)(2)(C) of the Act),OEM China Wall Mounted Book Shelf Factory - Aj Union - 149916.

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