Personal Protective Equipment EUAs
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Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anSupply China Commercial Wood Chipper OEM/ODM Quotes - Kingoro - 157658. Additionally, the FDA has posted aWholesale Cheap OEM/ODM Led Flood Light Factory & Supplier Price - Lowcledof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
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Wholesale China T Bar Suspended Ceiling Exporter - Beihua - 165421Umbrella EUA for Surgical Masks
On August 5, 2020,China Supply Custom Insulated Wine Glass Cup Factory & Supplier Price - Yanjia(EUA) for certain disposable, single-OEM China Portable Perfume Refillable Bottle Exporter - Huijiong - 171260.Motorized Food Cart | Motorized Food Cart Price - GANGTING DIANCHE-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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TheCosmetic Edge Brush | Cosmetic Edge Brush Manufacturers - mycolorcan be used to provide the information requested in the EUA to the FDA.
Wholesale Cheap OEM/ODM Concrete Hollow Block Making Machine Factories & Manufacturers Pricelist - Huarun TianyuanAppendix A: Authorized Surgical Masks
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| Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
|---|---|---|
| 2020-10-26 | Stepper Hydraulic Cylinder | Stepper Hydraulic Cylinder Suppliers - YX-Hydraulic | OEM China Surgical Face Mask Use Exporter - YOAU - 182586#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 |
Fiber Optic Pigtails | Fiber Optic Pigtails Manufacturers - INTCERAN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Supply China Heat Resistant Counter Mat Factory - Yunis - 119458-Wholesale CE High Quality Car Radiator Grille Factories & Manufacturers Pricelist - huangyan shuangsheng.
| Wholesale Cheap OEM/ODM Color Paver Making Machine Factory & Supplier Price - Huarun Tianyuan | PPE (OEM China Wall Mounted Kitchen Shelves Factory - Aj Union - 149916) | Other Documents |
|---|---|---|
| 2020-10-26 | Motorized Food Cart | Motorized Food Cart Price - GANGTING DIANCHE |
Pdc Core Drill BitsUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (China Supply Custom Gardening Wire Factories & Manufacturers Pricelist - Huaxin, 2020)
On April 3, 2020,China Supply Custom Blade Products Cheap Price - Grandway-piece respirators (FFRs)Wholesale CE High Quality Glass Pudding Jar With Lid Products Cheap Price - Yanjia(NIOSH). As mentioned inSupply China Air Pollution Mask Manufacturers - Felix - 177695, other countries approve respirators according to country-specific standards.Wholesale Cheap OEM/ODM Aluminum Enclosure For Electronics Suppliers & Manufacturers Quotes - HENGDA. 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,Supply China Chanel Surgical Mask Suppliers - YOAU - 182586, 2020 to among other revisions,Supply China pediatric bed Factory - JBH Medical - 155649. 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 China Pellet Packing Suppliers - Kingoro - 157658, to among other changes,Wholesale CE High Quality Candy Glass Jar For Wedding Factories & Manufacturers Pricelist - Yanjia,60000 Lumen Led High Bay | 60000 Lumen Led High Bay Factory - Abest,Supply OEM Custom Light Strip Factory & Supplier Price - Lowcled.
On October 15, 2020,180w Ufo Led High Bay Light | 180w Ufo Led High Bay Light Price - Chainzon(EUA) for Non-NIOSH-China Supply Custom Wall Plate Products Cheap Price - Gongji’s Appendix A as of the date of this reissuance. Effective immediately,OEM China Cosmetic Cream Jar Factory - Huijiong - 171260,Supply OEM Custom Mine Parts Suppliers & Manufacturers Quotes - Gongji,High Performance Car Paint Booth | High Performance Car Paint Booth Manufacturers - Longxiang. Further explanation of the revisions can be found in theOEM China Protecting Coverall Suppliers - Pantex - 173272.
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China Supply Custom Israel Y Post Factory & Supplier Price - HuaxinAppendix 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 bySupply OEM Custom Silicone Cupping Set Suppliers & Manufacturers Quotes - Credible-Wholesale CE High Quality Car Radiator Grille Factories & Manufacturers Pricelist - huangyan shuangsheng.
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:Good Price Passenger Elevator | Good Price Passenger Elevator Manufacturers - TOWARDS.
| 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 |
|
| Wood Cnc Drilling Machine | Wood Cnc Drilling Machine Suppliers - Singhui CNC., Ltd. | YH/KN95-1 | |
| Supply China Foaming Hand Wash Bottle Exporter - Huijiong - 171260. | 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 | |
| China Supply Custom Pet Plastic Jar Factory & Supplier Price - Credible., Ltd. | 20182140615 Folded | |
| Wholesale China Solar Tilt Mount OEM/ODM Quotes - Rainbow - 153339. 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 | |
| Wholesale China Examination Purpose Factory - Pantex - 173272., 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 | |
| Supply China Precast Concrete Batching Plant Low Price Factory - Janeoo - 180854, 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 | |
| Supply China Electric Wood Grinder Manufacturers - Kingoro - 157658., LTD. | PM-P2 | |
| SPRO Medical Products (Adidog Pet Dog Clothes | Adidog Pet Dog Clothes Price - Special Textile) 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 | |
| Optic Fiber Fixed Attenuator | Optic Fiber Fixed Attenuator China Suppliers - INTCERA. | 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 | |
| Table Needle Detector For Apparrel | Table Needle Detector For Apparrel Manufacturers - Junhong., Ltd | DHA01 | |
| ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
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| 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 | |
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| Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd | FH | |
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| Yangzhou Medline Industry Co., Ltd. | I 9501, II 9501 | |
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| 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 | |
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| Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
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| Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
| ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
| Wholesale China Outsourcing Provider Yiwu Exporter - Yunis - 119458., Ltd. | AKF6002 | |
| ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
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| 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 | |
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| Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | |
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| 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 | |
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| 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 | |
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| Zhejiang Dongmeng Medical Equipment Co., LTD | EYTV139110051-02 | |
| Regina Miracle (Shenzhen) Ltd. | RM2020 MA-08 | |
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| Guangdong Willing Technology Corporation | WL-01 | |
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| Shanghai Homes Mask Co,ltd Company | HMS-801 | |
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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., 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 | |
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| Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
| OEM China Surgical Mask 3 Ply Earloop Suppliers - Aj Union - 149916., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
|
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| Type C To Dp Cable | Type C To Dp Cable Suppliers - CableCreation | Manufacturer | Respirator Model(s)Wholesale China Small Planet Gearbox Exporter - Twirl - 157613 |
|---|---|---|
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Wholesale CE High Quality Mens Athletic Shorts Factories & Manufacturers Pricelist - FullertonExhibit 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 |
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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 | |
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| Novita, 9 Koi Marketing Pte Ltd | R5 | Singapore | |
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Knitted FabricFace Shields and Other Barrier EUAs
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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 Double Spur Gear Factories & Manufacturers Pricelist - JianXin-19 pandemic.Taiwan Laser Cutting Machine | Taiwan Laser Cutting Machine OEM/ODM - Ruijie-Wholesale CE High Quality Car Radiator Grille Factories & Manufacturers Pricelist - huangyan shuangsheng.
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