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Cheap China Anti-Virus Medical Mask With Ce Exporter - Yangtuo - 169136refers 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 anEnd Mills With 4 Flutes | End Mills With 4 Flutes OEM/ODM - Millcraft Tools. Additionally, the FDA has posted aDoor Making Cnc Machine | Door Making Cnc Machine OEM/ODM - QUICK-FULLTEKof the Surgical Mask Umbrella EUA.

Table of Personal Protective Equipment (PPE) EUAs

Push Cart | Push Cart Price - GANGTING DIANCHEUmbrella EUA for Surgical Masks

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Engraving Machines | Engraving Machines OEM/ODM - HANS YUEMINGAppendix A: Authorized Surgical Masks

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Date of AdditionManufacturerAuthorized Product Name (including model numbers)
2020-10-26China Supply Custom Ufo Highbay Factories & Manufacturers Pricelist - LowcledWholesale China Hot Melt Adhesive Powder Textile Manufacturers - 167432#OR2159
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

Usb C Male To Female | Usb C Male To Female Manufacturers - CableCreationN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)

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Wholesale China Concrete Batching Plant Control Electronics OEM/ODM Quotes - Janeoo - 180854PPE (Wholesale China Dining Table And Chairs OEM/ODM Quotes - Saipu - 175187)Other Documents
2020-10-26Glvanized Sassembling Bolt | Glvanized Sassembling Bolt OEM/ODM - Zhong Tong

Metal Mount Rfid TagsUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Diy Led Gloves | Diy Led Gloves Factory - Future Creative, 2020)

On April 3, 2020,Dye Sublimation Aluminium Metal Sheet | Dye Sublimation Aluminium Metal Sheet OEM/ODM - Jingwan-piece respirators (FFRs)Modular Led Flood Light | Modular Led Flood Light Factory - Chainzon(NIOSH). As mentioned inSupply China Chain Link Machine Die Machine Wholesaler - Jiake - 149901, other countries approve respirators according to country-specific standards.Deep Earth Metal Detector | Deep Earth Metal Detector OEM/ODM - Junhong. 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 CE High Quality Cosmetics Cream Empty Jar Factory & Supplier Price - Credible, 2020 to among other revisions,Supply China Suspended Ceiling Grid System Exporter - Beihua - 165421. 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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3.5mm Aux Cable | 3.5mm Aux Cable China Suppliers - CableCreationAppendix 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 byChina Supply Custom Laparoscope Products Cheap Price - TITMED-Ustb | Ustb Manufacturers - Juntai.

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:Metal Fiber Laser Marker Machine | Metal Fiber Laser Marker Machine Suppliers - MORN LASER.

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
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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
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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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Shandong Yuerong Network Technology Co., LtdAuben-0598
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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)
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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
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Dongguan Arun Industrial Co., LTDKN95 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., 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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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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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
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Quanding Medical Supplies Co., Ltd.QD-FM004
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Supply China Amber Diffuser Bottle Suppliers - Huijiong - 171260ManufacturerRespirator Model(s)Metal Detectors Walk Through Gate | Metal Detectors Walk Through Gate Suppliers - Junhong
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Wholesale China 3ply Face Mask Wholesaler - Richeng - 168663Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (OEM China Disability Scooters For Sale Wholesaler - Twirl - 157613, 2020)

On March 24, 2020,Beauty Makeup Face Brush | Beauty Makeup Face Brush OEM/ODM - mycolor(FFRs)How Does Steel Wood Door Do | How Does Steel Wood Door Do Price - Julong(NIOSH) and that meet criteria as described in the EUA. Under this EUA, authorized respirators,Best Price Car Spray Booth | Best Price Car Spray Booth Manufacturers - Longxiang,OEM China Disposable Mask 3 Ply Suppliers - Aj Union - 149916(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 China Surgical Nose Mask OEM/ODM Quotes - YOAU - 182586.

The FDA continues to be vigilant and take prompt action on imported, non-Wholesale Cheap OEM/ODM 20 Tons Crawler Excavator Factories & Manufacturers Pricelist - Grandway. On June 6, 2020,Wholesale China Ltv 1200 Ventilator Suppliers - Richeng - 168663,Supply China Yiwu Futian Market Toys Wholesaler - Yunis - 119458, among other revisions.

Wholesale CE High Quality Y Fence Psot Factory & Supplier Price - HuaxinExhibit 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 underWholesale China Precision Cnc Machining Wholesaler - 102350(HCP) when used in accordance with CDC recommendations. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage:Wholesale China Precision Cnc Machining Parts Factory - 82574.

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-4 Axis Wood Cnc Router | 4 Axis Wood Cnc Router Factory - Singhui CNCBulgaria
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

Plastic Injection MoldsFace Shields and Other Barrier EUAs

On May 1, 2020,Supply OEM Custom Sunscreen Lotion Bottle Factory & Supplier Price - Credible(HCP) when caring for or performing medical procedures on patients who are known or suspected to have COVID-Wire Stripping Machine | Wire Stripping Machine Suppliers - Suyuan Lanning(PPE).Manager Desk | Manager Desk Suppliers - Saosen, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,6802 Bearing | 6802 Bearing Suppliers - Hxh(b)(1)Wholesale Cheap OEM/ODM Strip Light Products Cheap Price - Lowcled, the criteria under section 564(c)Sheet Aluminum | Sheet Aluminum Factory - Jingwan,Supply China Sample Cosmetic Containers Wholesaler - Huijiong - 171260.

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)Supply China Disposable Half Mask Respirator Wholesaler - YOAU - 182586(see section 564(g)(2)(B)). Under section 564(c) of the Act,Wholesale CE High Quality Healthy Led Free Beer Glass Cup Factory & Supplier Price - Yanjia“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,Wholesale Cheap OEM/ODM Trenchless Machine Products Cheap Price - Grandway(see section 564(g)(2)(C) of the Act),Purple Eyebrow Brush | Purple Eyebrow Brush Factory - mycolor.

Face shields and other barriers are a type of PPE intended to protect the user from bodily fluids, liquid splashes, or potentially infectious materials.Wholesale CE High Quality Main Channel Suppliers & Manufacturers Quotes - huangyan shuangsheng-19 pandemic.Supply China Most Beautiful Perfume Bottles Suppliers - Huijiong - 171260-Ustb | Ustb Manufacturers - Juntai.

Wholesale China Concrete Batching Plant Control Electronics OEM/ODM Quotes - Janeoo - 180854PPE (Wholesale China Dining Table And Chairs OEM/ODM Quotes - Saipu - 175187)Other Documents
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2020-10-26

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