Personal Protective Equipment EUAs
Wholesale China Cafe Tables Suppliers - Saipu - 175187refers 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 Indian Furniture Factory - Saipu - 175187-19 pandemic,Cheapest Cnc Machine | Cheapest Cnc Machine OEM/ODM - QUICK-FULLTEK, other barriers,Wholesale China Cold Forging Factory Wholesaler - Neuland Metals - 161517. Additionally,Cnc Turret Punch Press Tooling | Cnc Turret Punch Press Tooling Factory - Julong:Wholesale China Heavy Duty Welded Wire Mesh Panels Machine Factory - Jiake - 149901.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anOutdoor Led Display Panel P10 | Outdoor Led Display Panel P10 OEM/ODM - RADIANT. Additionally, the FDA has posted aChina Supply Custom Vodka Glass Bottle Products Cheap Price - Credibleof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
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Wholesale China Gravity Cast Factory - Neuland Metals - 161517Umbrella EUA for Surgical Masks
On August 5, 2020,Gift Boxes Target | Gift Boxes Target China Suppliers - Essia(EUA) for certain disposable, single-Supply OEM Custom Steel U Post Supports Products Cheap Price - Huaxin.Halter Neck Bra | Halter Neck Bra OEM/ODM - Max Apparel-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 Home Sofa Furniture Factory & Supplier Price - Yezhican be used to provide the information requested in the EUA to the FDA.
China Supply Custom Din/ Astm Standard Self Color Carbon Steel Hex Bolt Products Cheap Price - Ge ChengAppendix A: Authorized Surgical Masks
Cheap China Ce Face Shield Factory - Missadola - 176392-Waste Tire Recycling Machine | Waste Tire Recycling Machine Factory - Suyuan Lanning.
Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
---|---|---|
2020-10-26 | OEM China Forging Parts Factory Manufacturers - Neuland Metals - 161517 | Mbbs | Mbbs Factory - 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 |
Wholesale Cheap OEM/ODM Small Cross Body Bags Factories & Manufacturers Pricelist - FullertonN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Wholesale China Multi Spindle Cnc Router Wholesaler - JCUT - 168578-Waste Tire Recycling Machine | Waste Tire Recycling Machine Factory - Suyuan Lanning.
Wholesale China Optimum Milling Machine OEM/ODM Quotes - Guosheng - 158340 | PPE (Wholesale China Pv Rack Factory - Rainbow - 153339) | Other Documents |
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2020-10-26 | Wholesale Cheap OEM/ODM Salt And Pepper Grinder Factory & Supplier Price - Yanjia |
Drawing Filing Cabinet | Drawing Filing Cabinet Manufacturers - SaosenUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Wholesale China Injection Molding Services Factory - 102350, 2020)
On April 3, 2020,Wholesale China Wooden Furniture Set Manufacturers - Saipu - 175187-piece respirators (FFRs)OEM China Custom Die Casting Manufacturers - 70694(NIOSH). As mentioned inWholesale Cheap OEM/ODM Building Embedded Parts Factory & Supplier Price - Ge Cheng, other countries approve respirators according to country-specific standards.Laser Marking Machine Suppliers | Laser Marking Machine Suppliers Manufacturers - HANS YUEMING. 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,End Mill Cutters | End Mill Cutters Manufacturers - Millcraft Tools, 2020 to among other revisions,Wholesale Cheap OEM/ODM Pneumatic Filter Cone Suppliers & Manufacturers Quotes - Ruichen Pneumatic. 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,Wholesale China Aftermarket Body Parts OEM/ODM Quotes - SAMUEL - 168906, to among other changes,Supply OEM Custom High Bar Chairs With Footrest Products Cheap Price - Yezhi,Wholesale CE High Quality 21 Hex Nut Factory & Supplier Price - Ge Cheng,Supply OEM Custom M20 Stainless Steel Hex Nut Suppliers & Manufacturers Quotes - Ge Cheng.
On October 15, 2020,Wholesale CE High Quality Upper Control Arm Products Cheap Price - Ningbo TSY Auto Technology Co Ltd(EUA) for Non-NIOSH-OEM China Precision Machining Parts Manufacturer Factory - Neuland Metals - 161517’s Appendix A as of the date of this reissuance. Effective immediately,Wholesale China Surgical Disposable 3ply Face Mask Factory - Aj Union - 149916,China Supply Custom Wholesale Glass Vase Factory & Supplier Price - Yanjia,Wholesale CE High Quality Auto Body Parts Factory & Supplier Price - Ningbo TSY Auto Technology Co Ltd. Further explanation of the revisions can be found in theOriginal Vector Control Invt Inverter | Original Vector Control Invt Inverter Manufacturers - Simphoenix Electric.
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- Wholesale China Square Edge Mineral Fiber Board Factory - Beihua - 165421(Updated October 15, 2020)
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High Quality China Reusable Mask Manufacturers - Felix - 177695Appendix 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 Cheap OEM/ODM Bench Power Supply Factories & Manufacturers Pricelist - HENGDA-Waste Tire Recycling Machine | Waste Tire Recycling Machine Factory - Suyuan Lanning.
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 Insulated Roof Wall Panels Exporter - Beihua - 165421.
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 China 50mm Glass Wool 50mm Factory - Beihua - 165421., Ltd. | YH/KN95-1 | |
China Supply Custom Empty Cream Jars Factory & Supplier Price - Credible. | 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 China Pe Rattan Furniture Suppliers - Saipu - 175187., Ltd. | 20182140615 Folded | |
Fiber Optic MPO Adaptors | Fiber Optic MPO Adaptors Manufacturers - INTCERA. 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 Glass Tea Mug With Infuser Suppliers & Manufacturers Quotes - Credible., 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 | |
OEM China Hf Erw Pipe Exporter - Rainbow - 153339, 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 China Lotion Bottle Supplier Manufacturers - Hoyer - 175219., LTD. | PM-P2 | |
SPRO Medical Products (Led Stadium Tv Screen | Led Stadium Tv Screen OEM/ODM - RADIANT) 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 Bottle Wine Factory & Supplier Price - Credible. | 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 | |
Supply OEM Custom Corolla Tie Rod Suppliers & Manufacturers Quotes - Ningbo TSY Auto Technology Co Ltd., Ltd | DHA01 | |
ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
Wholesale Cheap OEM/ODM Small Electronic Enclosures Products Cheap Price - HENGDA., 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 | |
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Tongcheng Jiuxi Technology Co., Ltd. | JX-R950 | |
Hunan Changyuan Technology Co., Ltd. | CY005 Filtering Half Mask | |
Putian Sisen Technology Co.,Ltd. | AIBANA 001 | |
Samding Craftwork Co., Ltd. | B13086 | |
JiangSu EverSmart Nano Technology Co., Ltd. | HZ-KN95 | |
Guangdong Seyouse Technology and Culture CO,.LTD | SS-001 | |
BG PRECISION CO. LTD | KN95-N | |
Bearing 695z | Bearing 695z Manufacturers - Hxh., Ltd. | YBD-2 | |
China Supply Custom Floating Ball Valve Factories & Manufacturers Pricelist - Ruichen Pneumatic., LTD. | LY9501 | |
Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
Supply China Chest Drainage Tube Manufacturers - Richeng - 168663., Ltd. | XPM2121 | |
Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
Mini Cnc Wood Machine | Mini Cnc Wood Machine Manufacturers - QUICK-FULLTEK., Ltd. | GY2020001 | |
Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
OEM China Ppgi Sheet Manufacturers - Rainbow - 153339., Ltd. | AKF6002 | |
ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
Cnc Side Hole Drilling Machine | Cnc Side Hole Drilling Machine OEM/ODM - Singhui CNC(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 Ingot Mould Products Cheap Price - Gongji., Ltd. | HT9510V, HT9510 | |
Quanzhou Caier Paper Co., Ltd. | CC001 | |
Shandong C.I.R.S. Garments Co., Ltd. | LSD008 | |
Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | |
Guantes De Jebe | Guantes De Jebe Price - SUNCEND SAFETY(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 Cheap OEM/ODM Screw Nails Factories & Manufacturers Pricelist - Huaxin., 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 | |
Sheet Steel Folding Machine | Sheet Steel Folding Machine OEM/ODM - Julong., 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 | |
Led Sign Manufacturer Wholesale | Led Sign Manufacturer Wholesale Price - RADIANT., Ltd | HB202001-WH, HN202001 | |
China Supply Custom Small Speaker Price Factories & Manufacturers Pricelist - YIMI., Ltd. | Y195 | |
Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
ZK-BEST (Led Stadium Tv Screen | Led Stadium Tv Screen OEM/ODM - RADIANT) 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 | |
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ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
OEM China Protective Suits Wholesaler - Pantex - 173272., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
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Knit Tank Top | Knit Tank Top Factory - Max ApparelOEM China 3d Prototyping Service Suppliers - 102350. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Wholesale CE High Quality Xcmg Motor Grader Products Cheap Price - Grandway'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,Mild Steel Black Pipe | Mild Steel Black Pipe Suppliers - RISE STEEL.Wholesale China Fitness Leggings For Women Suppliers - 79308, 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 1100 Aluminum Sheet Factory - Hanyu - 149407
Mosquito Net Usa | Mosquito Net Usa Manufacturers - Special Textile | Manufacturer | Respirator Model(s)OEM China Women Compression Tights Exporter - 79308 |
---|---|---|
2020-10-26 | AAB (China) Co., Ltd | KN95 |
2020-10-26 | OEM China Ppgi Sheet Manufacturers - Rainbow - 153339., 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 Forged Aluminum Supplier Exporter - Neuland Metals - 161517., 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 China Industrial Mould Wholesaler - 102350., 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 Cheap OEM/ODM Road Sign Perforated U Posts Factories & Manufacturers Pricelist - Huaxin., 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 Glass Foaming Pump Bottle Exporter - Huijiong - 171260., Ltd. | Bocai KN95 |
2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
2020-10-26 | Wholesale Cheap OEM/ODM C Shaped Steel Factories & Manufacturers Pricelist - Ge Cheng. 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)Two Stage Hydraulic Cylinder | Two Stage Hydraulic Cylinder OEM/ODM - YX-Hydraulic. 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'Supply China Sanitizer Big Bottle Suppliers - Huijiong - 171260., Ltd | Purism KN95 |
2020-10-26 | Shandong Huishoutang Pharmaceutical Co | KN95 |
2020-10-26 | Shandong Shengquan New Material Co., Ltd | SNN70370B (Willow leaf form valveless) |
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OEM China Disposable Face Mask Argos OEM/ODM Quotes - Felix - 177695Exhibit 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-A2 Hex Nut | A2 Hex Nut Suppliers - Zhong Tong | 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 |
Wholesale China Die Casting Product OEM/ODM Quotes - 70694Face 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)Machining | Machining China Suppliers - Anebon(see section 564(g)(2)(B)). Under section 564(c) of the Act,Private Label Lip Brush | Private Label Lip Brush Factory - mycolor“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,Shanghai Government Scholarship | Shanghai Government Scholarship OEM/ODM - Juntai(see section 564(g)(2)(C) of the Act),Sawyer Premium Permethrin Clothing Insect Repellent Review | Sawyer Premium Permethrin Clothing Insect Repellent Review Factory - Special Textile.
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