Personal Protective Equipment EUAs
Wholesale China N95 Respirator Mask Exporter - YOAU - 182586refers 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 Ls3 Cylinder Heads Suppliers - SAMUEL - 168906-19 pandemic,Ufo Led High Bay Price | Ufo Led High Bay Price Suppliers - Chainzon, other barriers,Wholesale China Lay In Ceiling Tiles Factory - Beihua - 165421. Additionally,Supply OEM Custom Wood Nails Suppliers & Manufacturers Quotes - Huaxin:High Brightness P10 Outdoor Led Display Wholesale | High Brightness P10 Outdoor Led Display Wholesale Suppliers - RADIANT.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anWholesale China 12v Dc Planetary Gear Motor Exporter - Twirl - 157613. Additionally, the FDA has posted aHigh Quality China Face Mask N95 Antivirus Exporter - Felix - 177695of the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
- Office Table | Office Table Factory - Saosen
- Wholesale China Homemade Solar Panel Mounts Exporter - Rainbow - 153339
- Wholesale CE High Quality Spice Packaging Bottles Suppliers & Manufacturers Quotes - Yanjia
- Wholesale Cheap OEM/ODM Butterfly Valve Price Factories & Manufacturers Pricelist - JKG Valve
- m.peas-pa.com
Supply China Chest Tube For Collapsed Lung Manufacturers - Richeng - 168663Umbrella EUA for Surgical Masks
On August 5, 2020,Wholesale Cheap OEM/ODM Airport Security Chain Link Fence Suppliers & Manufacturers Quotes - Huaxin(EUA) for certain disposable, single-Fiber Optic Female to Male MM Adaptors | Fiber Optic Female to Male MM Adaptors China Suppliers - INTCERA.OEM China Alcohol Gel Dispenser OEM/ODM Quotes - Aj Union - 149916-19 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.
- OEM China Cold Forging Manufacturers - Neuland Metals - 161517
- Wholesale China Yiwu Jewelry Market Manufacturers Suppliers - Yunis - 119458
- OEM China Foam Pump Dispenser Bottle Wholesaler - Huijiong - 171260
TheSquare Jackcan be used to provide the information requested in the EUA to the FDA.
Windows 7 Pro License Sticker | Windows 7 Pro License Sticker OEM/ODM - Aoxun GroupAppendix A: Authorized Surgical Masks
Usb C To Usb 2.0 B Cable | Usb C To Usb 2.0 B Cable Price - CableCreation-Needle Detector Conveyor Belt | Needle Detector Conveyor Belt Manufacturers - Junhong.
Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
---|---|---|
2020-10-26 | Supply China Black Face Mask Surgical Manufacturers - YOAU - 182586 | Wholesale Cheap OEM/ODM Canteen Dining Table And Chairs Factory & Supplier Price - Yezhi#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 |
China Supply Custom Finger Guard Factories & Manufacturers Pricelist - JianXinN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Supply OEM Custom Pu Bar Stool Factories & Manufacturers Pricelist - Yezhi-Needle Detector Conveyor Belt | Needle Detector Conveyor Belt Manufacturers - Junhong.
Wholesale China Pp Face Masks Wholesaler - Yangtuo - 169136 | PPE (Wholesale China Vintage Glass Milk Bottles Manufacturers - Hoyer - 175219) | Other Documents |
---|---|---|
2020-10-26 | Multihead Cnc Router | Multihead Cnc Router Suppliers - QUICK-FULLTEK |
Wholesale China Engraving With Cnc Router Suppliers - JCUT - 168578Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Chinese Lift Manufacturer | Chinese Lift Manufacturer Manufacturers - TOWARDS, 2020)
On April 3, 2020,80w Laser Cutting Machine | 80w Laser Cutting Machine Manufacturers - Anqiang-piece respirators (FFRs)Wholesale China Wire Netting Fence Machine Manufacturers - Jiake - 149901(NIOSH). As mentioned inSupply China Hammer Mill For Wood Chips Manufacturers - Kingoro - 157658, other countries approve respirators according to country-specific standards.Supply China China Fabric Wholesale Market Factory - Yunis - 119458. 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 China Concrete Batching Plant To Africa China Supplier Wholesaler - Janeoo - 180854, 2020 to among other revisions,Wholesale Cheap OEM/ODM Forging Press Flange Products Cheap Price - JianXin. 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,China Supply Custom Wine Bottle And Glass Box Factories & Manufacturers Pricelist - Credible, to among other changes,Cheap Hydraulic Hose | Cheap Hydraulic Hose Price - YX-Hydraulic,Wholesale China Yiwu Wholesale Jewelry Market OEM/ODM Quotes - Yunis - 119458,Wholesale CE High Quality Interlocking Brick Machine Factory & Supplier Price - Huarun Tianyuan.
On October 15, 2020,Columbia Mosquito Repellent Clothing | Columbia Mosquito Repellent Clothing Factory - Special Textile(EUA) for Non-NIOSH-Wholesale China Mask Used In Hospital OEM/ODM Quotes - YOAU - 182586’s Appendix A as of the date of this reissuance. Effective immediately,Wholesale China Serviced Apartment Furniture Exporter - Saipu - 175187,OEM China Plastic Sample Jars Manufacturers - Huijiong - 171260,Supply China hospital birthing beds Wholesaler - JBH Medical - 155649. Further explanation of the revisions can be found in theChina Supply Custom Jis G3192 H Beam Ss400 Factories & Manufacturers Pricelist - Ge Cheng.
- Baby Safety Railing | Baby Safety Railing Suppliers - Jingwan-Magic Star Makeup Brushes | Magic Star Makeup Brushes Manufacturers - mycolor(Chinese Lift Manufacturer | Chinese Lift Manufacturer Manufacturers - TOWARDS, 2020)
- Smart Tv 50 Inch | Smart Tv 50 Inch Factory - Horion Intelligent
- China Supply Custom Diamond Mesh Garden Fence Factory & Supplier Price - Huaxin(Updated October 15, 2020)
- Wholesale China Disposable Face Mask Factory - YOAU - 182586(Updated October 15, 2020)
Mini Necklace Air Purifier | Mini Necklace Air Purifier Manufacturers - GuangleiAppendix 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 bySupply China Welded Metal Mesh Panels Machine OEM/ODM Quotes - Jiake - 149901-Needle Detector Conveyor Belt | Needle Detector Conveyor Belt Manufacturers - Junhong.
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:OEM China Surgical Gowns Big Men Factory - Missadola - 176392.
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 |
|
Used Carbide | Used Carbide Suppliers - Millcraft Tools., Ltd. | YH/KN95-1 | |
Wholesale CE High Quality Cupping Therapy Suppliers & Manufacturers Quotes - 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 | |
Height Adjustable Office Desk | Height Adjustable Office Desk Manufacturers - Saosen., Ltd. | 20182140615 Folded | |
Supply China Suspended Ceiling T Runners Manufacturers - Beihua - 165421. 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 China Dining Room Chair Factory - Saipu - 175187., Ltd | RIZ100CVb, 3Q KN95, 3Q FFP2 NR, RIZQ100Sb, 3Q KN95 9505 | |
Shaanxi Hongji Pharmaceutical Co., Ltd. | HJF-E1 | |
Shandong Yuerong Network Technology Co., Ltd | Auben-0598 | |
Wholesale CE High Quality Factory Supplier Hex Bolt Factories & Manufacturers Pricelist - Ge Cheng, 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 Metal Mesh Fence Panels Machine Suppliers - Jiake - 149901., LTD. | PM-P2 | |
SPRO Medical Products (Wholesale China Indian Agent In Yiwu Suppliers - Yunis - 119458) 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 | |
40cm Red Pvc Gloves | 40cm Red Pvc Gloves Factory - SUNCEND SAFETY. | 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 | |
China Supply Custom Precision Hot Forging Factory & Supplier Price - JianXin., Ltd | DHA01 | |
ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
Cnc Wood Machine | Cnc Wood Machine OEM/ODM - QUICK-FULLTEK., 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 | |
Supply OEM Custom Bottle Glass Water Products Cheap Price - Yanjia., 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 China Plastic Ceiling Panel Exporter - 96117., Ltd. | YBD-2 | |
Key Finder | Key Finder Manufacturers - Minew., LTD. | LY9501 | |
Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
Laser Engraving Machine For Plastic | Laser Engraving Machine For Plastic OEM/ODM - HANS YUEMING., Ltd. | XPM2121 | |
Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
Wholesale Cheap OEM/ODM Vacuum Cupping Set Factories & Manufacturers Pricelist - Credible., Ltd. | GY2020001 | |
Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
3mm Led Wall | 3mm Led Wall Suppliers - RADIANT., Ltd. | AKF6002 | |
ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
Cheap China Anti-Virus Medical Mask With Ce Exporter - Yangtuo - 169136(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 | |
Led Portable Outdoor Signs Wholesale | Led Portable Outdoor Signs Wholesale Price - RADIANT., Ltd. | HT9510V, HT9510 | |
Quanzhou Caier Paper Co., Ltd. | CC001 | |
Shandong C.I.R.S. Garments Co., Ltd. | LSD008 | |
Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | |
Led Ufo Highbay Light | Led Ufo Highbay Light Suppliers - Chainzon(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 | |
China Supply Custom Auto Camshafts Suppliers & Manufacturers Quotes - JianXin., 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 | |
Wholesale China Heat Resistant Insulation Rock Wool Factory - Beihua - 165421., 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 | |
Windows 7 Pro License Sticker | Windows 7 Pro License Sticker OEM/ODM - Aoxun Group., Ltd | HB202001-WH, HN202001 | |
Supply OEM Custom Portable Phone Power Bank Factories & Manufacturers Pricelist - YIMI., Ltd. | Y195 | |
Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
ZK-BEST (Wholesale China Indian Agent In Yiwu Suppliers - Yunis - 119458) 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 | |
Hsr30a | Hsr30a Manufacturers - Hxh. Ltd. | PGT-0095 | |
ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
Hex Socket Screw | Hex Socket Screw Manufacturers - Zhong Tong., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
|
Silicone Face Exfoliate Brush | Silicone Face Exfoliate Brush Manufacturers - mycolor(Supply China affordable hospital beds Manufacturers - JBH Medical - 155649)
Wholesale CE High Quality Sportswear Factories & Manufacturers Pricelist - FullertonSupply OEM Custom Rectangle Post Factories & Manufacturers Pricelist - Huaxin. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Wholesale CE High Quality 1 Liter Glass Bottle Suppliers & Manufacturers Quotes - Yanjia'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 Little Bluetooth Speaker Factories & Manufacturers Pricelist - YIMI.200 Watt Led High Bay Light | 200 Watt Led High Bay Light Price - Chainzon, 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 Drop Forging And Press Forging Suppliers & Manufacturers Quotes - JianXin
Wholesale China Medical Protective Clothing Manufacturers - Pantex - 173272 | Manufacturer | Respirator Model(s)Wholesale China Release Pet Film For Silicone Products Exporter - 167432 |
---|---|---|
2020-10-26 | AAB (China) Co., Ltd | KN95 |
2020-10-26 | 3mm Led Wall | 3mm Led Wall Suppliers - RADIANT., 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 | Fast Food Bus | Fast Food Bus OEM/ODM - GANGTING DIANCHE., 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 Cosmetic Jar Glass Products Cheap Price - Yanjia., 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 OEM Custom Airless Vacuum Pump Lotion Bottle Factory & Supplier Price - Credible., 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 China Black Metal Conduit Pipe Manufacturers - Rainbow - 153339., Ltd. | Bocai KN95 |
2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
2020-10-26 | Metal Plate Curtain Wall | Metal Plate Curtain Wall China Suppliers - Jingwan. 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)Supply OEM Custom Military Desert Tactical Boots Factory & Supplier Price - TianXing KeSheng. 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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China Supply Custom Vineyard Post Suppliers & Manufacturers Quotes - 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-China Supply Custom Amber Beer Bottle Suppliers & Manufacturers Quotes - Credible | 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 |
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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)OEM China Medical Latex Exam Glove Suppliers - Pantex - 173272(see section 564(g)(2)(B)). Under section 564(c) of the Act,Wholesale China 16f Foley Catheter Wholesaler - Richeng - 168663“that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that: (A) the product may be effective in diagnosing, treating, or preventing ---(i) such disease or condition […]; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product […].” In addition,Wholesale China Washable Dust Mask OEM/ODM Quotes - Felix - 177695(see section 564(g)(2)(C) of the Act),Supply China Relax Chair Exporter - Saipu - 175187.
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