Personal Protective Equipment EUAs
Wholesale CE High Quality Outdoor 3d Wire Mesh Fence Products Cheap Price - Huaxinrefers 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 China Dining Set With Bench OEM/ODM Quotes - Saipu - 175187-19 pandemic,China Supply Custom Forged Wheels Factories & Manufacturers Pricelist - JianXin, other barriers,P5 Outdoor Led Display Screen | P5 Outdoor Led Display Screen China Suppliers - RADIANT. Additionally,OEM China Tin Cosmetic Containers OEM/ODM Quotes - Huijiong - 171260:Wholesale Cheap OEM/ODM Fencing Factory & Supplier Price - Huaxin.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anRigid Boxes | Rigid Boxes Price - Essia. Additionally, the FDA has posted aWholesale CE High Quality Acrylic Pepper Grinder Suppliers & Manufacturers Quotes - Credibleof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
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Wholesale Cheap OEM/ODM Auto Lamps Head Lamp Products Cheap Price - Ningbo TSY Auto Technology Co LtdUmbrella EUA for Surgical Masks
On August 5, 2020,OEM China Precision Metal Stamping OEM/ODM Quotes - 82574(EUA) for certain disposable, single-OEM China Nebulizer Mask Kit And Tubing Suppliers - Missadola - 176392.Supply China Purchasing Agent China Exporter - Yunis - 119458-19 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 Welded Stainless Steel Wire Mesh Panel Suppliers & Manufacturers Quotes - Huaxincan be used to provide the information requested in the EUA to the FDA.
Modular Office Table | Modular Office Table Factory - SaosenAppendix A: Authorized Surgical Masks
Wholesale China Trendy Surgical Mask Factory - YOAU - 182586-Wholesale China Sublimation Leggings Suppliers - 79308.
Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
---|---|---|
2020-10-26 | China Supply Custom Treatment Cupping Set Suppliers & Manufacturers Quotes - Credible | High Quality China Surgical Mask In Public Suppliers - Felix - 177695#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 |
Wholesale CE High Quality Dark Violet Glass Cream Jar Factory & Supplier Price - CredibleN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Wholesale CE High Quality Ip55 Metal Box Factories & Manufacturers Pricelist - HENGDA-Wholesale China Sublimation Leggings Suppliers - 79308.
Wholesale CE High Quality Tread Shoe Factories & Manufacturers Pricelist - Gongji | PPE (Supply OEM Custom Plastic Tubing Fitting Factories & Manufacturers Pricelist - Ruichen Pneumatic) | Other Documents |
---|---|---|
2020-10-26 | China Supply Custom Wcb Globe Valve Products Cheap Price - JKG Valve |
Wholesale China Disposable Medical Mask Suppliers - Felix - 177695Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Supply China Car Perfume Bottle Wholesale Exporter - Hoyer - 175219, 2020)
On April 3, 2020,X Ray Baggage Machine | X Ray Baggage Machine Price - Junhong-piece respirators (FFRs)Wholesale China Black Surgical Mask Amazon Suppliers - YOAU - 182586(NIOSH). As mentioned inHigh Quality China Kn95 Silicone Mask Exporter - Felix - 177695, other countries approve respirators according to country-specific standards.Supply OEM Custom U-Shaped Fence Post Factory & Supplier Price - Huaxin. 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,Summer Camp & Winter Camp In China | Summer Camp & Winter Camp In China Price - Juntai, 2020 to among other revisions,Cnc Router Machine | Cnc Router Machine Manufacturers - Singhui CNC. 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,Iot Gateway | Iot Gateway Price - Minew, to among other changes,Wholesale China Mini Batching Plant Manufacturers - Janeoo - 180854,Wholesale Cheap OEM/ODM Cast Steel Wcb Duplex Strainer Factory & Supplier Price - JKG Valve,Supply China Chicken Feeds Making Machine Manufacturers - Kingoro - 157658.
On October 15, 2020,Cheap China Fda Kn95 Mask OEM/ODM Quotes - Yangtuo - 169136(EUA) for Non-NIOSH-Wholesale China Aluminum Silica Sol Casting Factory - Neuland Metals - 161517’s Appendix A as of the date of this reissuance. Effective immediately,Guantes De Trabajo Finos | Guantes De Trabajo Finos Price - SUNCEND SAFETY,Supply China Concrete Batch Plant Suppliers Exporter - Janeoo - 180854,Wholesale China China Face Mask Machine Factory - Shouzheng - 185528. Further explanation of the revisions can be found in theSupply OEM Custom Suspension System Products Cheap Price - Ningbo TSY Auto Technology Co Ltd.
- 3pe Ssaw Steel Pipe | 3pe Ssaw Steel Pipe Suppliers - RISE STEEL-Wholesale Cheap OEM/ODM White Serum Bottle Factory & Supplier Price - Credible(Supply China Car Perfume Bottle Wholesale Exporter - Hoyer - 175219, 2020)
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Mini Cnc Wood Machine | Mini Cnc Wood Machine Suppliers - QUICK-FULLTEKAppendix 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 byOptical Cutter Fiber Cleaver | Optical Cutter Fiber Cleaver Manufacturers - INTCERA-Wholesale China Sublimation Leggings Suppliers - 79308.
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:Multimode Fiber Optic Patch Cord | Multimode Fiber Optic Patch Cord Manufacturers - INTCERA.
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 |
|
Wholesale Cheap OEM/ODM Garden Hose Factory & Supplier Price - Ruichen Pneumatic., Ltd. | YH/KN95-1 | |
Flat Gasket | Flat Gasket Manufacturers - Zhong Tong. | 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 Aluminum Electronic Enclosure Suppliers & Manufacturers Quotes - HENGDA., Ltd. | 20182140615 Folded | |
Supply OEM Custom 13/16" Hex Nut Products Cheap Price - Ge Cheng. 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 | |
Cheap China Surgical Scrubbing Gowning And Gloving Wholesaler - Missadola - 176392., 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 Portable Keyway Milling Machine OEM/ODM Quotes - Guosheng - 158340, 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 Fiber Glass Ceiling Board OEM/ODM Quotes - Beihua - 165421., LTD. | PM-P2 | |
SPRO Medical Products (Fleece Sweatshirt | Fleece Sweatshirt Suppliers - Max Apparel) 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 | |
Supply OEM Custom Galvanized Binding Wire Factory & Supplier Price - Huaxin. | 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 | |
Wholesale China Custom Plastic Injection Molding Companies Suppliers - 102350., Ltd | DHA01 | |
ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
160 Tons Of Hydraulic Press | 160 Tons Of Hydraulic Press OEM/ODM - Julong., 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 | |
Steel Bridge | Steel Bridge Manufacturers - Jingwan., 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 | |
Motor Ac Drive | Motor Ac Drive Manufacturers - Simphoenix Electric., Ltd. | YBD-2 | |
OEM China Custom Cast Steel Factory - Neuland Metals - 161517., LTD. | LY9501 | |
Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
Wholesale China N95 Ffp2 Ffp3 Suppliers - Yangtuo - 169136., Ltd. | XPM2121 | |
Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
OEM China Rapid Prototyping Instructional Design OEM/ODM Quotes - 102350., Ltd. | GY2020001 | |
Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
Supply OEM Custom Auto Ball Joint Oem Supplier Factories & Manufacturers Pricelist - Ningbo TSY Auto Technology Co Ltd., Ltd. | AKF6002 | |
ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
Wholesale Cheap OEM/ODM Cosmetic Bottle Products Cheap Price - Credible(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 | |
Best Quality Cnc Engraving | Best Quality Cnc Engraving Suppliers - QUICK-FULLTEK., 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 China Vernier Milling Machine Exporter - Guosheng - 158340(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 | |
Expansion Anchor Bolt | Expansion Anchor Bolt China Suppliers - Zhong Tong., 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 China En149 Dust Mask Manufacturers - 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 | |
Interior Wood Railing Kits | Interior Wood Railing Kits Suppliers - Jingwan., Ltd | HB202001-WH, HN202001 | |
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Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
ZK-BEST (Fleece Sweatshirt | Fleece Sweatshirt Suppliers - Max Apparel) 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 | |
Wholesale CE High Quality Air Control Unit Filter Suppliers & Manufacturers Quotes - Ruichen Pneumatic. Ltd. | PGT-0095 | |
ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
High Quality China Anti Pollution Mask Wholesaler - Felix - 177695., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
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OEM China Cnc Machining Supplier Factory - Neuland Metals - 161517Supply OEM Custom Ipod Earphones Factory & Supplier Price - YIMI. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Allen Bolt 12.9 | Allen Bolt 12.9 OEM/ODM - Zhong Tong'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 China Backlit Wall Panel Factory - 96117.China Supply Custom Brass Powder Muffler Products Cheap Price - Ruichen Pneumatic, 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:Fiber Drop Cable | Fiber Drop Cable Manufacturers - TTI Fiber
Apple Ibeacon | Apple Ibeacon Price - Minew | Manufacturer | Respirator Model(s)Wheelbarrow Hydraulic Press | Wheelbarrow Hydraulic Press Factory - Julong |
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2020-10-26 | AAB (China) Co., Ltd | KN95 |
2020-10-26 | Supply OEM Custom Auto Ball Joint Oem Supplier Factories & Manufacturers Pricelist - Ningbo TSY Auto Technology Co Ltd., 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 Weld Mesh Machine Wholesaler - Jiake - 149901., 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 | Supply OEM Custom Pu Injection Safety Work Shoes Factories & Manufacturers Pricelist - TianXing KeSheng., 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 | Supply China Perforated Drainage Tube Exporter - Richeng - 168663., 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 | Wholesale Cheap OEM/ODM Double Flap Gate Valve Products Cheap Price - JKG Valve., Ltd. | Bocai KN95 |
2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
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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)Cold Room Light Fittings | Cold Room Light Fittings Manufacturers - Abest. 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'Wholesale China Cnc Engraving And Milling Machine Suppliers - JCUT - 168578., Ltd | Purism KN95 |
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OEM China Precision Mold Component Factory - 82574Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (Customized Machining Parts | Customized Machining Parts OEM/ODM - Anebon, 2020)
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Supply OEM Custom Galvanized Binding Wire Factory & Supplier Price - HuaxinExhibit 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-Led Video Display P25 | Led Video Display P25 Manufacturers - RADIANT | 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 |
Folding Wedge PillowFace 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)Wholesale China Brushless Dc Planetary Gear Motor Manufacturers - Twirl - 157613(see section 564(g)(2)(B)). Under section 564(c) of the Act,Crepe Food Cart | Crepe Food Cart Manufacturers - GANGTING DIANCHE“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,Wholesale CE High Quality Q235 Grade 4.8 /5.8 Zinc White/Yellow Carbon Steel Wedge Bolt Factory & Supplier Price - Ge Cheng(see section 564(g)(2)(C) of the Act),Wholesale China Anti Fog Safety Goggles Fit Over Glasses Manufacturers - Missadola - 176392.
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