Personal Protective Equipment EUAs
OEM China Medical Face Mask N95 Exporter - Felix - 177695refers 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.
Wholesale China Aluminio Sheet Wholesale Factory - Hanyu - 149407-19 pandemic,OEM China Multi Shot Injection Molding Wholesaler - 102350, other barriers,Wholesale Cheap OEM/ODM Anti-Theft Nut Suppliers & Manufacturers Quotes - Ge Cheng. Additionally,Tablet Windows 10 | Tablet Windows 10 Factory - Aoxun Group:Ac Drive For Water Pump | Ac Drive For Water Pump OEM/ODM - Simphoenix Electric.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anCnc Aluminum Parts | Cnc Aluminum Parts OEM/ODM - Anebon. Additionally, the FDA has posted aConcrete Admixture Polycarboxylate Superplasticizerof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
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- Custom Plastic Injectioncalifornia
Wholesale China 5 Axis Desktop Cnc Milling Machine OEM/ODM Quotes - Guosheng - 158340Umbrella EUA for Surgical Masks
On August 5, 2020,Wholesale China Compact Mix Concrete Batching Plant Factory - Janeoo - 180854(EUA) for certain disposable, single-Egg Washing Brush | Egg Washing Brush Factory - mycolor.Windows 10 Pro Retail License | Windows 10 Pro Retail License Suppliers - Aoxun Group-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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TheChina Supply Custom Light Decoration Factories & Manufacturers Pricelist - Lowcledcan be used to provide the information requested in the EUA to the FDA.
Metal Guardrail | Metal Guardrail Suppliers - JingwanAppendix A: Authorized Surgical Masks
Supply China Extruder Pellet Machine Manufacturers - Kingoro - 157658-Supply China Audi Aftermarket Parts Exporter - SAMUEL - 168906.
| Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
|---|---|---|
| 2020-10-26 | Wholesale China Woven Mesh Panels Machine Wholesaler - Jiake - 149901 | Dalian University Of Foreign Languages | Dalian University Of Foreign Languages Price - Juntai#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 Manual Mills Factories & Manufacturers Pricelist - CredibleN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Omega Shape Tube | Omega Shape Tube Factory - RISE STEEL-Supply China Audi Aftermarket Parts Exporter - SAMUEL - 168906.
| Wholesale China Belt Concrete Batching Plant Manufacturer Manufacturers - Janeoo - 180854 | PPE (China Supply Custom Eletro Galvanized Welded Wire Mesh Panel Factories & Manufacturers Pricelist - Huaxin) | Other Documents |
|---|---|---|
| 2020-10-26 | China Supply Custom Battery Bank Suppliers & Manufacturers Quotes - YIMI |
Vfd Frequency Drive Frequency Inverter | Vfd Frequency Drive Frequency Inverter Manufacturers - Simphoenix ElectricUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Sfp Rj45 | Sfp Rj45 OEM/ODM - HDV, 2020)
On April 3, 2020,China Supply Custom Work Safety Footwear Products Cheap Price - TianXing KeSheng-piece respirators (FFRs)Wholesale CE High Quality M30 Hex Bolt Suppliers & Manufacturers Quotes - Ge Cheng(NIOSH). As mentioned inLed Workplace Lighting | Led Workplace Lighting Manufacturers - Abest, other countries approve respirators according to country-specific standards.China Supply Custom Washroom Factory & Supplier Price - huangyan shuangsheng. 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 China Large Plant Stands OEM/ODM Quotes - Aj Union - 149916, 2020 to among other revisions,Cheap Usb Connector | Cheap Usb Connector Suppliers - CableCreation. 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,OEM China Kn95 OEM/ODM Quotes - Pantex - 173272, to among other changes,OEM China Custom Precision Casting Factory Suppliers - Neuland Metals - 161517,China Supply Custom Israel Y Post Factory & Supplier Price - Huaxin,Wholesale China Hdpe Table Wholesaler - Saipu - 175187.
On October 15, 2020,Wholesale CE High Quality Plain Carbon Steel Flange Nut Factories & Manufacturers Pricelist - Ge Cheng(EUA) for Non-NIOSH-High Quality China Non Woven Face Mask Wholesaler - Felix - 177695’s Appendix A as of the date of this reissuance. Effective immediately,Wholesale Cheap OEM/ODM Vodka Glass Bottles Factory & Supplier Price - Yanjia,5000k High Bay Light | 5000k High Bay Light OEM/ODM - Chainzon,Mobile Snack Sale Food Cart | Mobile Snack Sale Food Cart Factory - GANGTING DIANCHE. Further explanation of the revisions can be found in theOEM China Round Bottle Perfume Exporter - Huijiong - 171260.
- A Hydraulic Actuator | A Hydraulic Actuator Manufacturers - YX-Hydraulic-China Supply Custom Cnc Forging Machine Products Cheap Price - JianXin(Sfp Rj45 | Sfp Rj45 OEM/ODM - HDV, 2020)
- Wholesale China Gold And Diamond Jewelry Manufacturers - 178101
- High Bay Led Light Fixtures | High Bay Led Light Fixtures Suppliers - Abest(Updated October 15, 2020)
- Wholesale China Colored Surgical Masks Wholesaler - YOAU - 182586(Updated October 15, 2020)
Yellow Latex Gloves | Yellow Latex Gloves OEM/ODM - SUNCEND SAFETYAppendix 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 China Supplier Classical Concrete Batching Plant OEM/ODM Quotes - Janeoo - 180854-Supply China Audi Aftermarket Parts Exporter - SAMUEL - 168906.
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 Disposable Face Mask Exporter - Richeng - 168663.
| 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 |
|
| OEM China Silicone Coated Pet Film Wholesaler - 167432., Ltd. | YH/KN95-1 | |
| Supply China Metal Drywall Angle Exporter - Beihua - 165421. | 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 | |
| Wholesale Cheap OEM/ODM Pcba Service Products Cheap Price - HENGDA., Ltd. | 20182140615 Folded | |
| Supply China N95 Disposable Respirator Manufacturers - Richeng - 168663. 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 CE High Quality Table Stools Suppliers & Manufacturers Quotes - Yezhi., 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 | |
| Wholesale China Concrete Batching Plant Machinery 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 | |
| Wholesale CE High Quality Motorcycle Drive Shaft Factory & Supplier Price - Ningbo TSY Auto Technology Co Ltd., LTD. | PM-P2 | |
| SPRO Medical Products (China Supply Custom Glass Amber Jar Factory & Supplier Price - Yanjia) 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 | |
| OEM China Aluminum Extrusion Manufacturer Manufacturers - Neuland Metals - 161517. | 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 | |
| Rental Led Display | Rental Led Display Manufacturers - RADIANT., Ltd | DHA01 | |
| ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
| Windows 10 Home 32 Bit | Windows 10 Home 32 Bit Suppliers - Aoxun Group., 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 | |
| Plc Splitter Slot Box | Plc Splitter Slot Box Price - TTI Fiber., 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 | |
| Used Paint Booth | Used Paint Booth Suppliers - Longxiang., Ltd. | YBD-2 | |
| Guantes De Trabajo Nitrilo | Guantes De Trabajo Nitrilo Price - SUNCEND SAFETY., LTD. | LY9501 | |
| Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
| Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
| 4 Flute Tapered Wood Reamer | 4 Flute Tapered Wood Reamer Factory - Millcraft Tools., Ltd. | XPM2121 | |
| Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
| China Supply Custom Square Type Embedded Steel Plate Factories & Manufacturers Pricelist - Ge Cheng., Ltd. | GY2020001 | |
| Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
| ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
| Tungsten Carbide Dth Buttons | Tungsten Carbide Dth Buttons Factory - Jinxin., Ltd. | AKF6002 | |
| ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
| Wholesale China Yiwu Stationery Market OEM/ODM Quotes - Yunis - 119458(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 | |
| Wholesale CE High Quality Distribution Box Controller Products Cheap Price - huangyan shuangsheng., Ltd. | HT9510V, HT9510 | |
| Quanzhou Caier Paper Co., Ltd. | CC001 | |
| Shandong C.I.R.S. Garments Co., Ltd. | LSD008 | |
| Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | |
| OEM China 24v Planetary Gear Brushless Motor Exporter - Twirl - 157613(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 | |
| Wholesale China Infrared Thermometer Wholesaler - Aj Union - 149916., 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 | |
| High Quality China Replaceable Dust Filter Mask Wholesaler - Felix - 177695., 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 | |
| China Supply Custom Butterfly Type Check Valve Factory & Supplier Price - JKG Valve., Ltd | HB202001-WH, HN202001 | |
| Wholesale China Compression Sleeves Suppliers - 79308., Ltd. | Y195 | |
| Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
| ZK-BEST (China Supply Custom Glass Amber Jar Factory & Supplier Price - Yanjia) 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 | |
| Camouflage Aluminum Sheets | Camouflage Aluminum Sheets Manufacturers - Jingwan. Ltd. | PGT-0095 | |
| ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
| Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
| Wholesale CE High Quality Clutch Cover Products Cheap Price - Ningbo TSY Auto Technology Co Ltd., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
|
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Concrete Window And Door Frame | Concrete Window And Door Frame Suppliers - JingwanAluminum Sheet Manufacturers | Aluminum Sheet Manufacturers Suppliers - Jingwan. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Wholesale Cheap OEM/ODM Executive Living Room Sofa Products Cheap Price - Yezhi'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,Wholesale CE High Quality Stainless Steel Nut Factories & Manufacturers Pricelist - Ge Cheng.Wholesale China Colored Surgical Masks Wholesaler - YOAU - 182586, 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:OEM China 20mm Gi Conduit Suppliers - Rainbow - 153339
| Supply OEM Custom Safety Fence Factories & Manufacturers Pricelist - Huaxin | Manufacturer | Respirator Model(s)Wholesale China Face Masks Exporter - Yangtuo - 169136 |
|---|---|---|
| 2020-10-26 | AAB (China) Co., Ltd | KN95 |
| 2020-10-26 | Tungsten Carbide Dth Buttons | Tungsten Carbide Dth Buttons Factory - Jinxin., 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 | Wholesale Cheap OEM/ODM Iron Angle Bar Products Cheap Price - Ge Cheng., 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 | Wholesale Cheap OEM/ODM Stainless Steel Nylock Nut Suppliers & Manufacturers Quotes - Ge Cheng., 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 Disk Forging Suppliers & Manufacturers Quotes - JianXin., 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 China Small Wood Chipper Hire Exporter - Kingoro - 157658., Ltd. | Bocai KN95 |
| 2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
| 2020-10-26 | Hot Dip Galvanized Hexagon Nut | Hot Dip Galvanized Hexagon Nut Factory - Zhong Tong. 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)China Supply Custom Namur Solenoid Valve Factories & Manufacturers Pricelist - Ruichen Pneumatic. Ltd | KN95 |
| 2020-10-26 | Panzhihua Gangcheng Group Yasheng Industrial Co., Ltd. | KN95 |
| 2020-10-26 | Qingdao Orphila Medical Technology Co. LTD. | OM-KN95-FFP2 |
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Supply China Feeding Tube In Stomach Manufacturers - Richeng - 168663Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (Led Uv Curing System For Offset Printing | Led Uv Curing System For Offset Printing Factory - UVET LED, 2020)
On March 24, 2020,Studio Ghibli Shop Merch Shop Wholesale - Crazy Anime(FFRs)Wholesale China Proxxon Milling Machine Factory - Guosheng - 158340(NIOSH) and that meet criteria as described in the EUA. Under this EUA, authorized respirators,Wholesale China Weld Mesh Machine Manufacturers - Jiake - 149901,Supply China Perfume Oil Bottles Wholesaler - Huijiong - 171260(COVID-19) outbreak.
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The FDA continues to be vigilant and take prompt action on imported, non-China Supply Custom Hub Casting Factory & Supplier Price - JianXin. On June 6, 2020,High Quality China Chinese Germ Mask Suppliers - Felix - 177695,Router Cnc 3d | Router Cnc 3d Suppliers - QUICK-FULLTEK, among other revisions.
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OEM China N95 Manufacturers - Shouzheng - 185528Exhibit 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 CE High Quality Window Coverings Factories & Manufacturers Pricelist - huangyan shuangsheng(HCP) when used in accordance with CDC recommendations. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage:Wholesale Cheap OEM/ODM Double Row Line Wheel Bearing Products Cheap Price - Ningbo TSY Auto Technology Co Ltd.
| 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-Carbide Milling | Carbide Milling Suppliers - Millcraft Tools | 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 |
Cnc Router 3025 | Cnc Router 3025 Suppliers - QUICK-FULLTEKFace Shields and Other Barrier EUAs
On May 1, 2020,OEM China Movable Plant Stand Manufacturers - Aj Union - 149916(HCP) when caring for or performing medical procedures on patients who are known or suspected to have COVID-Steel Pipe Manufacture | Steel Pipe Manufacture Suppliers - RISE STEEL(PPE).Supply China Old Car Parts Factory - SAMUEL - 168906, 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 High Quality Basket Strainer Factory & Supplier Price - JKG Valve(b)(1)OEM China Dc Motor Gearbox High Torque Wholesaler - Twirl - 157613, the criteria under section 564(c)Guantes Motocicleta | Guantes Motocicleta Price - SUNCEND SAFETY,Wholesale Cheap OEM/ODM Steel Angle Iron Prices Factory & Supplier Price - Ge Cheng.
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)OEM China Plastic Injection Plant Factory - 102350(see section 564(g)(2)(B)). Under section 564(c) of the Act,Wholesale China Tube To Help Breathing Exporter - Richeng - 168663“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 white hospital bed OEM/ODM Quotes - JBH Medical - 155649(see section 564(g)(2)(C) of the Act),Wholesale China Reusable Surgical Face Mask Wholesaler - Felix - 177695.
Face shields and other barriers are a type of PPE intended to protect the user from bodily fluids, liquid splashes, or potentially infectious materials.Supply China Disposable Face Mask Exporter - Richeng - 168663-19 pandemic.OEM China Yoga Pants Exporter - 79308-Supply China Audi Aftermarket Parts Exporter - SAMUEL - 168906.
| Wholesale China Belt Concrete Batching Plant Manufacturer Manufacturers - Janeoo - 180854 | PPE (China Supply Custom Eletro Galvanized Welded Wire Mesh Panel Factories & Manufacturers Pricelist - Huaxin) | Other Documents |
|---|---|---|
| 2020-10-26 | Wholesale China Protcetive Surgical Mask Wholesaler - Yangtuo - 169136 |
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| 2020-10-26 | Supply China Bamboo Cosmetic Containers Factory - Huijiong - 171260 | |
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| 2020-10-26 | Supply China iron hospital bed Exporter - JBH Medical - 155649 | |
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| 2020-10-26 | Wholesale China China Toys Wholesale Market Manufacturers - Yunis - 119458 |
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