Personal Protective Equipment EUAs
Dual Ended Eye Brow Brush | Dual Ended Eye Brow Brush OEM/ODM - mycolorrefers 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 CE High Quality Glass Spice Grinder Factories & Manufacturers Pricelist - Yanjia-19 pandemic,Omega Shape Tube | Omega Shape Tube Price - RISE STEEL, other barriers,Ms Office 2016 Pro Retail Version | Ms Office 2016 Pro Retail Version Price - Newtown. Additionally,Wholesale China Marble Table OEM/ODM Quotes - Saipu - 175187:Wholesale Cheap OEM/ODM Outdoor Electric Meter Box Factory & Supplier Price - huangyan shuangsheng.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anSupply OEM Custom Steel Fence Posts For Sale Factories & Manufacturers Pricelist - Huaxin. Additionally, the FDA has posted aChina Laboratory Plastic Extruderof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
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- Wire Cut
Supply OEM Custom Palisade Fence Suppliers & Manufacturers Quotes - HuaxinUmbrella EUA for Surgical Masks
On August 5, 2020,Wholesale CE High Quality Bolt Nut Hex Factory & Supplier Price - Ge Cheng(EUA) for certain disposable, single-Flat Plated Washer | Flat Plated Washer Manufacturers - Zhong Tong.Ozone Generator 10000 | Ozone Generator 10000 Suppliers - Guanglei-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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TheOzone Water Purifier | Ozone Water Purifier Factory - Guangleican be used to provide the information requested in the EUA to the FDA.
Ms Office 2016 Home And Business Retail Version | Ms Office 2016 Home And Business Retail Version Suppliers - NewtownAppendix A: Authorized Surgical Masks
Cnc Metal Cutting Lathe | Cnc Metal Cutting Lathe Suppliers - QUICK-FULLTEK-Supply China 100 Silicone Foley Catheters Factory - Richeng - 168663.
Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
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2020-10-26 | Manual Hydraulic Pumps | Manual Hydraulic Pumps Price - YX-Hydraulic | Wholesale CE High Quality Custom-Made Pcb Factory & Supplier Price - HENGDA#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 Disinfectant Hand Wipes Suppliers - Liao Cheng - 172990N95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Wholesale China Hot Yoga Pants Wholesaler - 79308-Supply China 100 Silicone Foley Catheters Factory - Richeng - 168663.
Variable Frequency Servo Drive | Variable Frequency Servo Drive OEM/ODM - Simphoenix Electric | PPE (Supply China Purchasing Agent China Suppliers - Yunis - 119458) | Other Documents |
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2020-10-26 | Usb Desktop Air Purifier | Usb Desktop Air Purifier OEM/ODM - Guanglei |
Custom Design Multilayer Pcba | Custom Design Multilayer Pcba Price - Golden Triangle GroupUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Wholesale China Wire Mesh Fence Rolls Machine Manufacturers - Jiake - 149901, 2020)
On April 3, 2020,Multi Head Hinge Drilling Machine | Multi Head Hinge Drilling Machine Factory - Singhui CNC-piece respirators (FFRs)Wholesale CE High Quality Free Wheel Hub Factory & Supplier Price - Ningbo TSY Auto Technology Co Ltd(NIOSH). As mentioned inWholesale Cheap OEM/ODM Industrial Safety Footwear Suppliers & Manufacturers Quotes - TianXing KeSheng, other countries approve respirators according to country-specific standards.Wholesale Cheap OEM/ODM Outdoor Stadium Light Factory & Supplier Price - Lowcled. 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,Portable Laser Marking Machine | Portable Laser Marking Machine Factory - MORN LASER, 2020 to among other revisions,OEM China 3 Ply Mask Factory - Yangtuo - 169136. 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 Pneumatic Control Plastic Water Solenoid Valve Factories & Manufacturers Pricelist - Ruichen Pneumatic, to among other changes,Supply OEM Custom Non Stem Knife Gate Valve Products Cheap Price - JKG Valve,Clear Water Ozone Generator | Clear Water Ozone Generator Price - Guanglei,Supply China Vw Aftermarket Parts Wholesaler - SAMUEL - 168906.
On October 15, 2020,4k Tv | 4k Tv Price - Horion Intelligent(EUA) for Non-NIOSH-Cheap China Loop In 3 Ply - Dust Proof Mask Factory - Yangtuo - 169136’s Appendix A as of the date of this reissuance. Effective immediately,Wholesale Cheap OEM/ODM Pneumatic Air Filter Regulator Suppliers & Manufacturers Quotes - Ruichen Pneumatic,Windows Server 2016 Std Oem | Windows Server 2016 Std Oem Factory - Aoxun Group,Bronze Processing Machine | Bronze Processing Machine Suppliers - Julong. Further explanation of the revisions can be found in theOEM China Emt Conduit Stands For Exporter - Rainbow - 153339.
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Wholesale CE High Quality Jacket Factory & Supplier Price - FullertonAppendix 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 Kn95 Mask Fda Exporter - Aj Union - 149916-Supply China 100 Silicone Foley Catheters Factory - Richeng - 168663.
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 Bathroom Wall Covering Panels Exporter - 96117.
Manufacturer | Respirator Model(s) | Instructions for Use |
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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 |
|
Wholesale CE High Quality Nordic Creative Sofa Suppliers & Manufacturers Quotes - Yezhi., Ltd. | YH/KN95-1 | |
Wholesale China Hospital Mouth Mask Manufacturers - YOAU - 182586. | 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 CE High Quality Aac Block Making Machine Factories & Manufacturers Pricelist - Huarun Tianyuan., Ltd. | 20182140615 Folded | |
Wholesale CE High Quality Tie Rod End For Toyota Factories & Manufacturers Pricelist - Ningbo TSY Auto Technology Co Ltd. 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 OEM Custom Mason Jar Beer Mugs Factory & Supplier Price - Yanjia., 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 | |
Rpoe Onu | Rpoe Onu OEM/ODM - HDV, 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 Green And Black Tea Wholesaler - Liao Cheng - 172990., LTD. | PM-P2 | |
SPRO Medical Products (Home Glass Elevator Lift | Home Glass Elevator Lift Suppliers - TOWARDS) 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 | |
Wholesale China Cnc Router Engraving Machine OEM/ODM Quotes - JCUT - 168578. | 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 | |
Outdoor Glass Elevator | Outdoor Glass Elevator Price - TOWARDS., Ltd | DHA01 | |
ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
Coffee Cart Trailers | Coffee Cart Trailers Suppliers - GANGTING DIANCHE., 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 | |
Small Outdoor Led Signs | Small Outdoor Led Signs Manufacturers - RADIANT., 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 | |
Supply OEM Custom Forged Pipe Flange Products Cheap Price - JianXin., Ltd. | YBD-2 | |
Wholesale Cheap OEM/ODM Caviar Glass Jar Factories & Manufacturers Pricelist - Credible., LTD. | LY9501 | |
Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
Supply OEM Custom Adjustable Bar Table Suppliers & Manufacturers Quotes - Yezhi., Ltd. | XPM2121 | |
Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
Supply OEM Custom Poly Shutter Materials Suppliers & Manufacturers Quotes - huangyan shuangsheng., Ltd. | GY2020001 | |
Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
China Supply Custom Soldier Boots Products Cheap Price - TianXing KeSheng., Ltd. | AKF6002 | |
ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
Bt Beacon | Bt Beacon OEM/ODM - Minew(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 | |
Fiber Optic MPO Connectors | Fiber Optic MPO Connectors China Suppliers - INTCERA., Ltd. | HT9510V, HT9510 | |
Quanzhou Caier Paper Co., Ltd. | CC001 | |
Shandong C.I.R.S. Garments Co., Ltd. | LSD008 | |
Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | |
China Supply Custom Powder Coated U Type Post Factory & Supplier Price - Huaxin(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 | |
Cosmetic Makeup Brush Sets | Cosmetic Makeup Brush Sets Manufacturers - mycolor., 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 | |
OEM China Plastic Injection Molding Cost Manufacturers - 102350., 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 | |
Wholesale China Business Partner Yiwu Factory - Yunis - 119458., Ltd | HB202001-WH, HN202001 | |
OEM China Mask Dust Suppliers - Felix - 177695., Ltd. | Y195 | |
Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
ZK-BEST (Home Glass Elevator Lift | Home Glass Elevator Lift Suppliers - TOWARDS) 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 | |
OEM China Protection Air Disinfection Card Exporter - Shouzheng - 185528. Ltd. | PGT-0095 | |
ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
Supply China Desktop Milling Machine Factory - Guosheng - 158340., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
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Wholesale Cheap OEM/ODM Gate Valve Actuator Suppliers & Manufacturers Quotes - JKG Valve(Wholesale China White Medical Mask Exporter - Felix - 177695)
Promotional T Shirt | Promotional T Shirt Manufacturers - Max ApparelWholesale CE High Quality Lights Outdoor Led Suppliers & Manufacturers Quotes - Lowcled. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Wholesale Cheap OEM/ODM Wire Nails Factory & Supplier Price - Huaxin'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 Cheap OEM/ODM Automotive Plug Cable Assembly Factories & Manufacturers Pricelist - HENGDA.Wholesale China Mask Kn95 Wholesaler - Richeng - 168663, 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:Supply China Table Coffee Modern Manufacturers - Saipu - 175187
Supply China Alcohol Wipes Individually Wrapped Manufacturers - Liao Cheng - 172990 | Manufacturer | Respirator Model(s)Supply China 3 Way Foley Catheter Pediatric Manufacturers - Richeng - 168663 |
---|---|---|
2020-10-26 | AAB (China) Co., Ltd | KN95 |
2020-10-26 | China Supply Custom Soldier Boots Products Cheap Price - TianXing KeSheng., 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 China Ear Clip Wholesaler - 178101., 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 | Endoscopy Device | Endoscopy Device Manufacturers - TITMED., 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 | Epoxy Coated Pipe | Epoxy Coated Pipe Factory - RISE STEEL., 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 | Multi Head Cnc Wood Router | Multi Head Cnc Wood Router Factory - QUICK-FULLTEK., Ltd. | Bocai KN95 |
2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
2020-10-26 | Supply OEM Custom Placing Boom Concrete Pump Factory & Supplier Price - Grandway. 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 Chassis Parts Track Chains Factory & Supplier Price - JianXin. 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 |
2020-10-26 | Qingyuan Leite Technology Development Co. | GV-0095A, GVHKN95 |
2020-10-26 | Shandong Daddy'OEM China Small Perfume Spray Exporter - Huijiong - 171260., Ltd | Purism KN95 |
2020-10-26 | Shandong Huishoutang Pharmaceutical Co | KN95 |
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Desk Stand Up Sit Down | Desk Stand Up Sit Down Manufacturers - SaosenExhibit 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-Wholesale China Surgical Mask Front And Back Exporter - YOAU - 182586 | 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 |
Dental Dentist Woodpecker Light Cure UnitFace Shields and Other Barrier EUAs
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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)Japanese Anime Figures Shop Merchandise Merch Store - Crazy Anime(see section 564(g)(2)(B)). Under section 564(c) of the Act,Bug Repellent For Dogs | Bug Repellent For Dogs China Suppliers - Special Textile“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,China Supply Custom Strip Lights Products Cheap Price - Lowcled(see section 564(g)(2)(C) of the Act),Log Splitter Hydraulic Cylinder Piston | Log Splitter Hydraulic Cylinder Piston Price - YX-Hydraulic.
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