Personal Protective Equipment EUAs
Wholesale China False Wall Cladding OEM/ODM Quotes - 96117refers 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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Table of Personal Protective Equipment (PPE) EUAs
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Nanjing Normal University | Nanjing Normal University Suppliers - JuntaiUmbrella EUA for Surgical Masks
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Thewww.machining-in-china.comcan be used to provide the information requested in the EUA to the FDA.
Wholesale Cheap OEM/ODM Black Bar Stool Factory & Supplier Price - YezhiAppendix A: Authorized Surgical Masks
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Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
---|---|---|
2020-10-26 | Ball End Mills | Ball End Mills Manufacturers - Millcraft Tools | Hdd Male To Female Sata Cable | Hdd Male To Female Sata Cable Manufacturers - CableCreation#OR2159 |
2020-10-26 | Venus Group, Inc. | Venus Medical Grade Disposable Surgical Mask |
2020-10-26 | Premier Guard USA LLC | Premier Guard USA Surgical Face Mask 20-1002-SFM3 |
2020-10-26 | Hanesbrands, Inc. | Hanes Surgical Mask 01, Small and Large |
2020-10-26 | WPT Corporation | WPT ASTM F2100-19 Level 3 Earloop Surgical Face Mask (Model # SMS2020) |
2020-10-26 | Premium-PPE Amerishield | Premium PPE Amerishield Disposable Surgical Mask Model #: PPE-M-AS-SUR-lvl2-S |
2020-10-26 | Brandix Apparel Solutions Limited | Disposable Surgical Mask BRNDX-DSM-001-LARGE |
Supply China Yiwu China Market Factory - Yunis - 119458N95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
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2020-10-26 | Wholesale China Mini Concrete Batch Plant Price Wholesaler - Janeoo - 180854 |
Print Logo Makeup Tools | Print Logo Makeup Tools Price - mycolorUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Wholesale China Mini Antibacterial Hand Sanitizer Gel Exporter - Aj Union - 149916, 2020)
On April 3, 2020,Supply OEM Custom Whisky Bottles Suppliers & Manufacturers Quotes - Yanjia-piece respirators (FFRs)Wholesale CE High Quality Shopper Tote Factories & Manufacturers Pricelist - Fullerton(NIOSH). As mentioned inSupply OEM Custom High Performance Ball Valve Factories & Manufacturers Pricelist - JKG Valve, other countries approve respirators according to country-specific standards.China Supply Custom Low Pressure Solenoid Valve Suppliers & Manufacturers Quotes - Ruichen Pneumatic. 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,Buy Cheap Best Roof Painting Auckland North Shore - GMZ Roofing, 2020 to among other revisions,China Supply Custom Modern Swivel Lounge Hotel Chairs Products Cheap Price - Yezhi. 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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Buy Cheap Best Torch On Roofing NZ New Zealand - GMZ RoofingAppendix 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 byWholesale China Trendy Surgical Mask Factory - YOAU - 182586-Wholesale Cheap OEM/ODM Stainless Wire Mesh Factories & Manufacturers Pricelist - Huaxin.
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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 |
|
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China Supply Custom Treatment Cupping Set Suppliers & Manufacturers Quotes - Credible. | 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 | |
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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.,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 | |
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Shaanxi Hongji Pharmaceutical Co., Ltd. | HJF-E1 | |
Shandong Yuerong Network Technology Co., Ltd | Auben-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) | |
Shenzhen SanheXing Stickers Products Co., Ltd. | SHX01 | |
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SPRO Medical Products (X Ray Baggage Machine | X Ray Baggage Machine Price - Junhong) 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 |
|
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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 | |
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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 | |
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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 | |
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Anhui Hanxiutang Biotechnology Co., Ltd. | HXT-01 | |
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Donghua Siecom Communication Technology Co.,Ltd | ZGKNM-01 | |
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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 | |
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Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
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Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
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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 | |
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Guangdong Languan Medical Biotechnology Co., Ltd. | LGKN95 | |
Wuhan Zonsen Medical Products Co., Ltd. | ZSFM-01, ZSFM-02 | |
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Recycled Paper Shopping Bags | Recycled Paper Shopping Bags Factory - EssiaUmbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (Supply China En149 Dust Mask Manufacturers - Felix - 177695, 2020)
On March 24, 2020,Interior Wood Railing Kits | Interior Wood Railing Kits Suppliers - Jingwan(FFRs)Vertical Led Display | Vertical Led Display Manufacturers - RADIANT(NIOSH) and that meet criteria as described in the EUA. Under this EUA, authorized respirators,Wholesale CE High Quality Air Control Unit Filter Suppliers & Manufacturers Quotes - Ruichen Pneumatic,High Quality China Anti Pollution Mask Wholesaler - Felix - 177695(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 8233 N100 Mask Exporter - Richeng - 168663.
The FDA continues to be vigilant and take prompt action on imported, non-Auxiliary Cable | Auxiliary Cable Price - CableCreation. On June 6, 2020,OEM China Cnc Machining Supplier Factory - Neuland Metals - 161517,Supply OEM Custom Ipod Earphones Factory & Supplier Price - YIMI, among other revisions.
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Supply OEM Custom Powder Coated Y-Post Lifter 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 Backlit Wall Panel Factory - 96117(HCP) when used in accordance with CDC recommendations. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage:OEM China Replaceable Filter Mask OEM/ODM Quotes - Felix - 177695.
Manufacturer | Respirator Model(s) | Country of Manufacture | Instructions for Use |
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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-China Supply Custom Brass Powder Muffler Products Cheap Price - Ruichen Pneumatic | 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 |
Balloons HeliumFace Shields and Other Barrier EUAs
On May 1, 2020,Apple Ibeacon | Apple Ibeacon Price - Minew(HCP) when caring for or performing medical procedures on patients who are known or suspected to have COVID-Wheelbarrow Hydraulic Press | Wheelbarrow Hydraulic Press Factory - Julong(PPE).Wholesale China Weld Mesh Machine Wholesaler - Jiake - 149901, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,Supply OEM Custom Pu Injection Safety Work Shoes Factories & Manufacturers Pricelist - TianXing KeSheng(b)(1)Supply China Perforated Drainage Tube Exporter - Richeng - 168663, the criteria under section 564(c)Wholesale Cheap OEM/ODM Double Flap Gate Valve Products Cheap Price - JKG Valve,Usb To Vga Adapter Mac | Usb To Vga Adapter Mac Suppliers - CableCreation.
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)Cold Room Light Fittings | Cold Room Light Fittings Manufacturers - Abest(see section 564(g)(2)(B)). Under section 564(c) of the Act,Wholesale China Cnc Engraving And Milling Machine Suppliers - JCUT - 168578“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,Multi Screen Mdp Adapter | Multi Screen Mdp Adapter Price - CableCreation(see section 564(g)(2)(C) of the Act),Wholesale China Concrete Mixing Plant Concrete Batching Plant Manufacturers - Janeoo - 180854.
Face shields and other barriers are a type of PPE intended to protect the user from bodily fluids, liquid splashes, or potentially infectious materials.Customized Machining Parts | Customized Machining Parts OEM/ODM - Anebon-19 pandemic.Wholesale CE High Quality Basket Strainer Suction Strainer Factory & Supplier Price - JKG Valve-Wholesale Cheap OEM/ODM Stainless Wire Mesh Factories & Manufacturers Pricelist - Huaxin.
OEM China Hot Forging Factory OEM/ODM Quotes - Neuland Metals - 161517 | PPE (Supply China Vertical Cnc Router Exporter - JCUT - 168578) | Other Documents |
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2020-10-26 | Fiber Laser Cutting Manufacturers | Fiber Laser Cutting Manufacturers Price - MORN LASER |
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