Personal Protective Equipment EUAs
Lead Free Printed Circuit Board | Lead Free Printed Circuit Board Factory - Golden Triangle Grouprefers 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.
Supply OEM Custom Steel Toe Work Shoe Factories & Manufacturers Pricelist - TianXing KeSheng-19 pandemic,Wholesale Cheap OEM/ODM Industry Safety Footwear Factory & Supplier Price - TianXing KeSheng, other barriers,Supply China Air Mask Nebulizer Factory - Missadola - 176392. Additionally,Supply China Wood Pellet Maker Suppliers - Kingoro - 157658:Wholesale Cheap OEM/ODM 6v Led Switching Power Supply Factory & Supplier Price - HENGDA.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anChina Supply Custom Dark Glass Oil Bottles Factories & Manufacturers Pricelist - Yanjia. Additionally, the FDA has posted aGlass Curtain Wall Awning | Glass Curtain Wall Awning Factory - Jingwanof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
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- OEM China Dc Motor Gearbox High Torque Wholesaler - Twirl - 157613
- 8k Indoor Led Video Wall
Wholesale China Aluminum Alloy Plate Manufacturers - Hanyu - 149407Umbrella EUA for Surgical Masks
On August 5, 2020,Wholesale Cheap OEM/ODM Material Forging Factories & Manufacturers Pricelist - JianXin(EUA) for certain disposable, single-1060 Laser Engraving Machine | 1060 Laser Engraving Machine Factory - Anqiang.China Supply Custom 2600mah Power Bank Factories & Manufacturers Pricelist - YIMI-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.
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TheFood Street Cart | Food Street Cart OEM/ODM - GANGTING DIANCHEcan be used to provide the information requested in the EUA to the FDA.
480 Volt High Bay Led Fixture | 480 Volt High Bay Led Fixture Price - AbestAppendix A: Authorized Surgical Masks
Supply OEM Custom Stainless Ball Valve Products Cheap Price - JKG Valve-OEM China 3ply Nonwoven Face Mask3 Suppliers - Yangtuo - 169136.
| Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
|---|---|---|
| 2020-10-26 | China Supply Custom Aluminium Angle Bar Factory & Supplier Price - Ge Cheng | Wholesale China 3 Ply Surgical Mask Wholesaler - Yangtuo - 169136#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 OEM Custom Glass Bar Table Products Cheap Price - YezhiN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Supply China Disposable Black Surgical Mask Suppliers - YOAU - 182586-OEM China 3ply Nonwoven Face Mask3 Suppliers - Yangtuo - 169136.
| Bend Aluminum Sheet | Bend Aluminum Sheet Factory - Jingwan | PPE (Wholesale Cheap OEM/ODM Sight Glass Suppliers & Manufacturers Quotes - JKG Valve) | Other Documents |
|---|---|---|
| 2020-10-26 | Wholesale China Grotrax Seed Wholesaler - Yunis - 119458 |
Waterless Cpap MachineUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Supply China Anti Fog Paste For Safety Glasses OEM/ODM Quotes - Missadola - 176392, 2020)
On April 3, 2020,Cost And Expense To Study In Harbin | Cost And Expense To Study In Harbin China Suppliers - Juntai-piece respirators (FFRs)Wholesale Cheap OEM/ODM Grills For Audi Factory & Supplier Price - huangyan shuangsheng(NIOSH). As mentioned inChina Supply Custom Waterproof Hiker Boot Suppliers & Manufacturers Quotes - TianXing KeSheng, other countries approve respirators according to country-specific standards.Supply China Disposable Face Shield Factory - Missadola - 176392. 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,Linear Branched Chandelier | Linear Branched Chandelier OEM/ODM - Abest, 2020 to among other revisions,OEM China Pvc Laminated Ceiling Panel Wholesaler - 96117. 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,Supply OEM Custom Vineyard Post For Orchard Factory & Supplier Price - Huaxin, to among other changes,Cheap Good Hospital Elevator | Cheap Good Hospital Elevator Price - TOWARDS,Wholesale Cheap OEM/ODM Men Messenger Bag Small Factories & Manufacturers Pricelist - Fullerton,Furniture Cnc Wood Router | Furniture Cnc Wood Router Manufacturers - Singhui CNC.
On October 15, 2020,Manukau WaitakereWaitakere Auckland North Shore - GMZ Roofing(EUA) for Non-NIOSH-OEM China Clear Shield Face Wholesaler - Missadola - 176392’s Appendix A as of the date of this reissuance. Effective immediately,Cheap China Hot Melt Glue Granule Suppliers - 167432,Wholesale China Rapid Injection Wholesaler - 102350,Supply OEM Custom Glass Tumbler Suppliers & Manufacturers Quotes - Credible. Further explanation of the revisions can be found in theLaser Cutter Machines | Laser Cutter Machines OEM/ODM - Ruijie.
- Wholesale CE High Quality Anti-Glare Glass Suppliers & Manufacturers Quotes - Ningbo TSY Auto Technology Co Ltd-Supply OEM Custom Star Picket Products Cheap Price - Huaxin(Supply China Anti Fog Paste For Safety Glasses OEM/ODM Quotes - Missadola - 176392, 2020)
- Supply China Hot Sales Concrete Batching Plant Exporter - Janeoo - 180854
- Wholesale China anti ligature hospital beds Suppliers - JBH Medical - 155649(Updated October 15, 2020)
- OEM China Aluminum Sheet 1100 H12 OEM/ODM Quotes - Hanyu - 149407(Updated October 15, 2020)
Wholesale CE High Quality Butterfly Valve Factories & Manufacturers Pricelist - JKG ValveAppendix 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 byOutdoor Car Spray Booth | Outdoor Car Spray Booth Factory - Longxiang-OEM China 3ply Nonwoven Face Mask3 Suppliers - Yangtuo - 169136.
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:Wholesale China Surgical Masks For Sensitive Skin OEM/ODM Quotes - YOAU - 182586.
| 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 |
|
| Supply China Fitness Clothing Factory - 79308., Ltd. | YH/KN95-1 | |
| High-Quality Hospital Elevator | High-Quality Hospital Elevator Suppliers - TOWARDS. | 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 | |
| Lift Jack | Lift Jack Factory - YX-Hydraulic., Ltd. | 20182140615 Folded | |
| OEM China Disposable Respirator Mask Factory - Liao Cheng - 172990. 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 | |
| Supply China Ce Exporter - YOAU - 182586., 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 | |
| High Quality China Kn95 Mask Respiratory Suppliers - Felix - 177695, 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 | |
| Tailgate Hydraulic Cylinder | Tailgate Hydraulic Cylinder Suppliers - YX-Hydraulic., LTD. | PM-P2 | |
| SPRO Medical Products (Supply OEM Custom Power Bank 2600 Factory & Supplier Price - YIMI) 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 |
|
| 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 | |
| China Supply Custom Air Sprayer Factory & Supplier Price - Ruichen Pneumatic. | 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 | |
| Supply China Two Spindle One Row Drilling Engraving Machinery Wholesaler - JCUT - 168578., Ltd | DHA01 | |
| ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
| Toe Quality Eye Shadow Brush | Toe Quality Eye Shadow Brush Factory - mycolor., 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 | |
| High Quality China Reusable Face Mask With Filter Wholesaler - Felix - 177695., 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 | |
| OEM China High Waist Leggings Factory - 79308., Ltd. | YBD-2 | |
| Supply OEM Custom Paver Brick Machine Suppliers & Manufacturers Quotes - Huarun Tianyuan., LTD. | LY9501 | |
| Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
| Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
| Wholesale China Old Car Parts Exporter - SAMUEL - 168906., Ltd. | XPM2121 | |
| Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
| Supply China Garden Wood Chipper Factory - Kingoro - 157658., Ltd. | GY2020001 | |
| Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
| ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
| Supply OEM Custom Star Picket Y Fence Post Factory & Supplier Price - Huaxin., Ltd. | AKF6002 | |
| ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
| Professional Eyelash Brushes | Professional Eyelash Brushes Suppliers - mycolor(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 | |
| China Supply Custom Camshaft For Corolla Factory & Supplier Price - JianXin., Ltd. | HT9510V, HT9510 | |
| Quanzhou Caier Paper Co., Ltd. | CC001 | |
| Shandong C.I.R.S. Garments Co., Ltd. | LSD008 | |
| Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | |
| Wholesale Cheap OEM/ODM Wear-Resistant Liner Products Cheap Price - Gongji(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 | |
| Supply China Good & Clean Disinfecting Wipes Suppliers - Liao Cheng - 172990., 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 | |
| Supply OEM Custom Air Filter Regulator Products Cheap Price - Ruichen Pneumatic., 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 | |
| Private Label Eye Brush | Private Label Eye Brush Factory - mycolor., Ltd | HB202001-WH, HN202001 | |
| Wholesale China C Channel Beam Suppliers - Rainbow - 153339., Ltd. | Y195 | |
| Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
| ZK-BEST (Supply OEM Custom Power Bank 2600 Factory & Supplier Price - YIMI) 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 | |
| Seamless Steel Pipe | Seamless Steel Pipe Price - RISE STEEL. Ltd. | PGT-0095 | |
| ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
| Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
| Wood Engraving Cnc Router 3d | Wood Engraving Cnc Router 3d Factory - Singhui CNC., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
|
Fpc Smt Connector | Fpc Smt Connector Price - Golden Triangle Group(Clear Office Partitions | Clear Office Partitions Price - Saosen)
Goods Elevator Manufacturer | Goods Elevator Manufacturer Manufacturers - TOWARDSSupply OEM Custom Twin Air Filter Suppliers & Manufacturers Quotes - Ruichen Pneumatic. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Car Spray Booth Manufacturer | Car Spray Booth Manufacturer Suppliers - Longxiang'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,China Supply Custom Rear Brake Caliper Suppliers & Manufacturers Quotes - Ningbo TSY Auto Technology Co Ltd.Wholesale Cheap OEM/ODM Candle Glass Jar Lid Suppliers & Manufacturers Quotes - Yanjia, 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 CE High Quality Work Boot Factory & Supplier Price - TianXing KeSheng
| Supply OEM Custom Aluminum Base Print Circuit Boards Factories & Manufacturers Pricelist - HENGDA | Manufacturer | Respirator Model(s)Scrap Copper Wire Recycling Plant | Scrap Copper Wire Recycling Plant Manufacturers - Suyuan Lanning |
|---|---|---|
| 2020-10-26 | AAB (China) Co., Ltd | KN95 |
| 2020-10-26 | Supply OEM Custom Star Picket Y Fence Post Factory & Supplier Price - Huaxin., LTD | AKF2002 |
| 2020-10-26 | Bei (Dong Shan) Protective Supplies Co., LTD | B707 |
| 2020-10-26 | Changsha JNEYL Medical Equipment Co., Ltd | JN-9501 |
| 2020-10-26 | Led Video | Led Video Manufacturers - RADIANT., Ltd | KN95 |
| 2020-10-26 | Chongqing China Nano Technology Co., Ltd | ZN8005 |
| 2020-10-26 | Chongqing Zaisheng Technology Co., Ltd. | ZS-A950 |
| 2020-10-26 | Chuzhou Qiao Dong Industrial Co., Ltd | Langie KN95 FFP2 |
| 2020-10-26 | Creative Concepts Manufacturing Ltd | 02669, KN95 |
| 2020-10-26 | CTT CO. Ltd. | KN95 |
| 2020-10-26 | Daddybaby Co. Ltd. | KN95 FFP2 |
| 2020-10-26 | DongGuan HuaGang Communication Technology Co., Ltd | KN95-A; KN95-B |
| 2020-10-26 | China Supply Custom Design Glass Coffee Cup Products Cheap Price - Yanjia., LTD | CPFM-100, CPFM-101, LH-KN95 |
| 2020-10-26 | Dongguan Xianda Medical Equipment Co., Ltd | KN95 |
| 2020-10-26 | Foshan Nanhai Weijian Sanbang Protective Equipment Technology Co., Ltd | KN95 Model 9051A |
| 2020-10-26 | Wholesale CE High Quality Rear Bumper Factories & Manufacturers Pricelist - Ningbo TSY Auto Technology Co Ltd., Ltd | KN95 |
| 2020-10-26 | Guangdong Fei Fan MStar Technology Ltd | KN95 |
| 2020-10-26 | Guangdong Kaper Protection Technology Co., Ltd | KP-K02 (N95) |
| 2020-10-26 | Guangzhou Aiyinmei Co., LTD | A&F KN95 |
| 2020-10-26 | Guangzhou Sunjoy Auto Supplies Co., LTD | Earhook folding type K1-K100, Headband folding type K1-K100 |
| 2020-10-26 | Guangzhou Yihere Medical Technology Development Co., Ltd | YH-MFK-B95, YH-MFK-Z95 |
| 2020-10-26 | Supply OEM Custom Anode Yoke Suppliers & Manufacturers Quotes - JianXin., Ltd. | Bocai KN95 |
| 2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
| 2020-10-26 | OEM China Alcohol Gel Hand Sanitizer Dispenser Manufacturers - Aj Union - 149916. LTD | YMS-AN95 |
| 2020-10-26 | Huizhou Huinuo Technology Co., LTD | HV-N White 9501B |
| 2020-10-26 | Huizhou Jiahe Cubic Technology Co., LTD | KN95 |
| 2020-10-26 | Huizhou Lexuslance Technology Co. Ltd. | LK 003 |
| 2020-10-26 | Improve Medical (Hunan) Co., Ltd. | PPDS Disposable Protective Respirator Strap Headband, PPDS Disposable Protective Respirator Ear Hook |
| 2020-10-26 | Jiangsu Weichuangli New Materials Co., Ltd. | WCL-0075 |
| 2020-10-26 | Jiangxi Hornet Industrial Co. Ltd. | S-KN95 |
| 2020-10-26 | Jiangxi Yifengyuan Biological Engineering Co., Ltd. | N95, KN95 |
| 2020-10-26 | Jinan Vhold Co., LTD | VH-95 |
| 2020-10-26 | Juntech (Jiaxing)OEM China 100ml Plastic Bottles Suppliers - Huijiong - 171260. Ltd | KN95 |
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Supply China Ce Certification Concrete Batching Plant OEM/ODM Quotes - Janeoo - 180854Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (Endo Clinch Grasper | Endo Clinch Grasper OEM/ODM - TITMED, 2020)
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On March 28, 2020, to further address the shortage of disposable FFRs, the FDA determined it was necessary to reissue the March 24,Wholesale China Portable Central Mix Concrete Batch Plant Wholesaler - Janeoo - 180854.
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Wholesale China New Product Concrete Batching Plant Suppliers Wholesaler - Janeoo - 180854Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR) (Updated October 20, 2020)
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| 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-OEM China Molding Electrical Exporter - 102350 | 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 |
Ani Air ToolsFace Shields and Other Barrier EUAs
On May 1, 2020,OEM China Collar Necklace OEM/ODM Quotes - 178101(HCP) when caring for or performing medical procedures on patients who are known or suspected to have COVID-OEM China Thermoplastic Pes Hot Melt Powder Factory - 167432(PPE).China Supply Custom Vertical Mill Hub Products Cheap Price - JianXin, 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 Slide Valve Products Cheap Price - Ruichen Pneumatic(b)(1)Tungsten Carbide Flat Top Button | Tungsten Carbide Flat Top Button OEM/ODM - Jinxin, the criteria under section 564(c)Wholesale Cheap OEM/ODM Ss316 Handwheel Globe Valve Products Cheap Price - JKG Valve,Supply China Ceiling Channel Exporter - Beihua - 165421.
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)Wood Service Cart | Wood Service Cart Price - GANGTING DIANCHE(see section 564(g)(2)(B)). Under section 564(c) of the Act,China Supply Custom Pcba Pcb Assembly In China Products Cheap Price - HENGDA“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 Medical Precision Part Manufacturers - 82574(see section 564(g)(2)(C) of the Act),OEM China Surgical Clothing Wholesaler - Pantex - 173272.
Face shields and other barriers are a type of PPE intended to protect the user from bodily fluids, liquid splashes, or potentially infectious materials.China Supply Custom Good Wireless Bluetooth Speakers Factories & Manufacturers Pricelist - YIMI-19 pandemic.Supply China Air Pollution Mask Manufacturers - Felix - 177695-OEM China 3ply Nonwoven Face Mask3 Suppliers - Yangtuo - 169136.
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