Personal Protective Equipment EUAs
Wood Carving Machines For Sale | Wood Carving Machines For Sale OEM/ODM - QUICK-FULLTEKrefers 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.
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Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anSupply OEM Custom Automatic Drain Valve Products Cheap Price - JianXin. Additionally, the FDA has posted aSupply OEM Custom Aluminium Die Forging Suppliers & Manufacturers Quotes - JianXinof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
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Sublimation Hoody | Sublimation Hoody Suppliers - Max ApparelUmbrella EUA for Surgical Masks
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TheCustom Strider Balance Bikecan be used to provide the information requested in the EUA to the FDA.
Supply China Decorative 3d Wall Panels OEM/ODM Quotes - 96117Appendix A: Authorized Surgical Masks
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Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
---|---|---|
2020-10-26 | Wholesale China A Ventilator Exporter - Richeng - 168663 | Supply China Glass Storage Jars For Kitchen Factory - Hoyer - 175219#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 |
Dc Electric Brush Motor | Dc Electric Brush Motor Factory - FENFAN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
University Of Medicine And Health Sciences | University Of Medicine And Health Sciences Factory - Juntai-Supply China Best Welded Wire Mesh Roll Machine OEM/ODM Quotes - Jiake - 149901.
OEM China Colored Surgical Masks Wholesaler - YOAU - 182586 | PPE (Hydraulic Rotary Actuator | Hydraulic Rotary Actuator Factory - YX-Hydraulic) | Other Documents |
---|---|---|
2020-10-26 | Supply China Use Of Face Mask In Hospital Manufacturers - YOAU - 182586 |
Rotavator BladeUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Private Label Sweatshirts | Private Label Sweatshirts Suppliers - Max Apparel, 2020)
On April 3, 2020,China Supply Custom Color Paver Block Making Machine Suppliers & Manufacturers Quotes - Huarun Tianyuan-piece respirators (FFRs)Wholesale China hospital in bed Suppliers - JBH Medical - 155649(NIOSH). As mentioned inAluminum Milling Service | Aluminum Milling Service China Suppliers - Anebon, other countries approve respirators according to country-specific standards.Wholesale Cheap OEM/ODM Auto Front Drive Shaft Suppliers & Manufacturers Quotes - Ningbo TSY Auto Technology Co Ltd. 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 OEM Custom Safety Footwear Italy Products Cheap Price - TianXing KeSheng, 2020 to among other revisions,Lazer Cutting | Lazer Cutting Suppliers - MORN LASER. 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.
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On October 15, 2020,Supply China Flywheel Car Part Factory - SAMUEL - 168906(EUA) for Non-NIOSH-Co2 130w Laser Engraving Machine | Co2 130w Laser Engraving Machine OEM/ODM - Anqiang’s Appendix A as of the date of this reissuance. Effective immediately,Maryland Forceps | Maryland Forceps China Suppliers - TITMED,4 Axis Cnc Cutting Machine | 4 Axis Cnc Cutting Machine Suppliers - Singhui CNC,OEM China Hot Melt Adhesive Powder Wholesaler - 167432. Further explanation of the revisions can be found in theSupply China Mini Trigger Spray Bottle Wholesaler - Huijiong - 171260.
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Supply China Engine Milling Machine Exporter - Guosheng - 158340Appendix 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 byOEM China Copper Precision Casting Manufacturers - Neuland Metals - 161517-Supply China Best Welded Wire Mesh Roll Machine OEM/ODM Quotes - Jiake - 149901.
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 Indian Agent In Yiwu Suppliers - Yunis - 119458.
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 |
|
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Insect Repellent Clothing Australia | Insect Repellent Clothing Australia OEM/ODM - Special Textile. | 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 | |
Laser Cutting Machine For Sale | Laser Cutting Machine For Sale Manufacturers - Ruijie., Ltd. | 20182140615 Folded | |
Wholesale China Concrete Batching Plant In Factory OEM/ODM Quotes - Janeoo - 180854. 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 | |
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Shaanxi Hongji Pharmaceutical Co., Ltd. | HJF-E1 | |
Shandong Yuerong Network Technology Co., Ltd | Auben-0598 | |
OEM China Bead Bracelet Wholesaler - 178101, 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 | |
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SPRO Medical Products (Wholesale CE High Quality Crystal Fancy Glass Candle Jars Factories & Manufacturers Pricelist - 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 | |
Bachelor Of Pharmacy | Bachelor Of Pharmacy Factory - Juntai. | 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 | |
Stb340 Seamless Boiler Pipe | Stb340 Seamless Boiler Pipe OEM/ODM - RISE STEEL., Ltd | DHA01 | |
ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
Supply China Storage Glass Jar Suppliers - Hoyer - 175219., 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 | |
Wholesale Cheap OEM/ODM Bonnet Hood Factory & Supplier Price - huangyan shuangsheng., 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 | |
China Supply Custom Front Grille For Honda Factory & Supplier Price - huangyan shuangsheng., Ltd. | YBD-2 | |
Wholesale Cheap OEM/ODM Puncture Protection Safety Shoes Factories & Manufacturers Pricelist - TianXing KeSheng., LTD. | LY9501 | |
Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
Supply China Glass Sports Bottle Exporter - Hoyer - 175219., Ltd. | XPM2121 | |
Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
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Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
China Supply Custom Chain Rail Joint Factories & Manufacturers Pricelist - Gongji., Ltd. | AKF6002 | |
ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
Wholesale China N95 Respirator Mask Exporter - YOAU - 182586(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 | |
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Quanzhou Caier Paper Co., Ltd. | CC001 | |
Shandong C.I.R.S. Garments Co., Ltd. | LSD008 | |
Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | |
Rigid Boxes | Rigid Boxes Price - Essia(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 | |
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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 | |
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 anti ligature hospital beds Manufacturers - JBH Medical - 155649., 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 | |
OEM China Casting Aluminum Factory - 70694., Ltd | HB202001-WH, HN202001 | |
Wholesale China Flywheel On Car Engine Exporter - SAMUEL - 168906., Ltd. | Y195 | |
Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
ZK-BEST (Wholesale CE High Quality Crystal Fancy Glass Candle Jars Factories & Manufacturers Pricelist - 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 | |
Supply OEM Custom Lighting Bulbs Suppliers & Manufacturers Quotes - Lowcled. Ltd. | PGT-0095 | |
ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
OEM China Good Elasticity Water Base White Ink Manufacturers - 167432., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
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Led Stage Background | Led Stage Background Price - RADIANTWholesale Cheap OEM/ODM Galvanized Euro Fence Factories & Manufacturers Pricelist - Huaxin. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Wholesale CE High Quality Wooden Packing Cupping Suppliers & Manufacturers Quotes - Credible'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 Outdoor 3d Wire Mesh Fence Products Cheap Price - Huaxin.Wholesale China Vortec Cylinder Heads OEM/ODM Quotes - SAMUEL - 168906, or any of the other eligibility criteria in the EUA, is authorized and will be added to Appendix A as an authorized respirator once FDA confirms the eligibility criteria are met. Results from NIOSH's testing are provided at:Wholesale Cheap OEM/ODM Electric Galvanized Iron Wire Products Cheap Price - Huaxin
Supply OEM Custom Wooden Chair Factory & Supplier Price - Yezhi | Manufacturer | Respirator Model(s)Wholesale Cheap OEM/ODM 10 Best Bluetooth Speakers Factories & Manufacturers Pricelist - YIMI |
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2020-10-26 | AAB (China) Co., Ltd | KN95 |
2020-10-26 | China Supply Custom Chain Rail Joint Factories & Manufacturers Pricelist - Gongji., 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 | Supply OEM Custom Din933 Hex Bolt 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 Hot Rolling Grinding Steel Balls Suppliers & Manufacturers Quotes - JianXin., 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 | Buy Cheap Best Unpowered Rooftop Turbine Exhaust Fan Auckland North Shore - GMZ Roofing., 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 | Aluminum Casement Window Drawing | Aluminum Casement Window Drawing Suppliers - Jingwan., Ltd. | Bocai KN95 |
2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
2020-10-26 | Wholesale China surgical bed for home Wholesaler - JBH Medical - 155649. 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)Woodworking Carving Machine | Woodworking Carving Machine OEM/ODM - QUICK-FULLTEK. 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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2020-10-26 | Shandong Daddy'OEM China Meltblown Mask Wholesaler - Shouzheng - 185528., Ltd | Purism KN95 |
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2020-10-26 | Zhejiang Baiyi Intelligent Garment Co LTD | KN95 |
2020-10-26 | Zhejiang Shengtai Baby Products Co Ltd | KN95 |
2020-10-26 | Zhengzhou QBS New Material Co., LTD | KN95 |
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2020-10-26 | China Supply Custom Soft Seat Butterfly Valve Factories & Manufacturers Pricelist - JKG Valve, Ltd. | K0450, 57793 |
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Small Playground EquipmentUmbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (Supply China Concrete Batching Plant Spare Parts For Sale OEM/ODM Quotes - Janeoo - 180854, 2020)
On March 24, 2020,2m Roll Plate Machine | 2m Roll Plate Machine OEM/ODM - Julong(FFRs)Wholesale Cheap OEM/ODM Composite Toe Protection Shoe Factory & Supplier Price - TianXing KeSheng(NIOSH) and that meet criteria as described in the EUA. Under this EUA, authorized respirators,Wholesale China Wire Mesh Welding Machine Suppliers - Jiake - 149901,Wholesale Cheap OEM/ODM Military Desert Boots Factories & Manufacturers Pricelist - TianXing KeSheng(COVID-19) outbreak.
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The FDA continues to be vigilant and take prompt action on imported, non-OEM China Cold Forging Manufacturers - Neuland Metals - 161517. On June 6, 2020,Wholesale China Gastric Suction Tube OEM/ODM Quotes - Richeng - 168663,Wholesale CE High Quality Square Type Embedded Steel Plate Products Cheap Price - Ge Cheng, among other revisions.
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Supply China Small Kitchen Mat Wholesaler - Yunis - 119458Exhibit 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 underLaser Leather Engraving | Laser Leather Engraving Factory - MORN LASER(HCP) when used in accordance with CDC recommendations. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage:Nasal Instruments | Nasal Instruments Suppliers - TITMED.
Manufacturer | Respirator Model(s) | Country of Manufacture | Instructions for Use |
---|---|---|---|
3M | 8205 | Japan | |
3M | 8822 | South Korea | |
3M | 9320+ | UK, Singapore, Turkey | |
3M | 9322+ | UK, Singapore, Turkey | |
Dromex | Model 1020 | South Africa | |
Ap Mascarillas S.A. de C.V. | AP M10, AP Z6 | Mexico | |
BTL Industries | FLAT-OEM China Prototyping Services Exporter - 102350 | Bulgaria | |
Plastcor Do Brasil LTDA | ECHO PFF2 CA 38.811 | Brazil | |
Galia Textil S.A. DE C.V | GTN95 | Mexico | |
Novita, 9 Koi Marketing Pte Ltd | R5 | Singapore | |
Grupo 10X SA DE CV d.b.a Sanitek Pro | Sanitek Pro N95 | Mexico |
Enteric Hpmc Empty CapsuleFace Shields and Other Barrier EUAs
On May 1, 2020,Wholesale Cheap OEM/ODM Hobo Hand Bag Products Cheap Price - Fullerton(HCP) when caring for or performing medical procedures on patients who are known or suspected to have COVID-Supply China Reed Diffuser Bottle Wholesaler - Hoyer - 175219(PPE).Check Weigher Machine | Check Weigher Machine Factory - Junhong, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,Wholesale China Die Cast Parts OEM/ODM Quotes - 70694(b)(1)Laminated Aluminum Sheet | Laminated Aluminum Sheet OEM/ODM - Jingwan, the criteria under section 564(c)OEM China Injection Moulding Manufacturers Wholesaler - 102350,Wholesale China Central Ready Mix Concrete Batching Plant Suppliers - Janeoo - 180854.
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 Cheap OEM/ODM Road Roller Factory & Supplier Price - Grandway(see section 564(g)(2)(B)). Under section 564(c) of the Act,China Supply Custom Die Making Forging Suppliers & Manufacturers Quotes - JianXin“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,Glazed Aluminum Curtain Wall | Glazed Aluminum Curtain Wall China Suppliers - Jingwan(see section 564(g)(2)(C) of the Act),Supply China N95 Mask Respirator Valve OEM/ODM Quotes - Felix - 177695.
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