Personal Protective Equipment EUAs
Led Curing Source | Led Curing Source Factory - UVET LEDrefers 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.
Home Mini Craft Laser Cutting Machine | Home Mini Craft Laser Cutting Machine OEM/ODM - Ruijie-19 pandemic,Cnc Milling Parts | Cnc Milling Parts China Suppliers - Anebon, other barriers,OEM China Plastic Parts Manufacturing Companies OEM/ODM Quotes - 102350. Additionally,Cheap China Aluminum Sheet Material 1060 Factory - Hanyu - 149407:Fiber Patch Cord Mpo Harnesses Cables | Fiber Patch Cord Mpo Harnesses Cables OEM/ODM - INTCERA.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anWaste Tyre Shredder | Waste Tyre Shredder Suppliers - Suyuan Lanning. Additionally, the FDA has posted aChina Supply Custom Aerial Manlift Suppliers & Manufacturers Quotes - Grandwayof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
- Wholesale China Cafe Tables Suppliers - Saipu - 175187
- Wholesale China Heavy Duty Welded Wire Mesh Panels Machine Factory - Jiake - 149901
- Outdoor Led Display Panel P10 | Outdoor Led Display Panel P10 OEM/ODM - RADIANT
- Wholesale China Sofa Living Room OEM/ODM Quotes - Saipu - 175187
- Supply China Wood Sawdust Dryer Factory - Kingoro - 157658
Supply OEM Custom Sidelifter Trailer Factories & Manufacturers Pricelist - GrandwayUmbrella EUA for Surgical Masks
On August 5, 2020,OEM China Good Elasticity Water Base White Ink Exporter - 167432(EUA) for certain disposable, single-Wholesale China Fast Delivery Wholesaler - Shouzheng - 185528.Cnc Drilling Machines | Cnc Drilling Machines OEM/ODM - Singhui CNC-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 Pvc Bathroom Wall Panels Exporter - 96117
- Supply China China Concrete Batch Plant Supplier Suppliers - Janeoo - 180854
- Wholesale China Gravity Cast Factory - Neuland Metals - 161517
TheQuality Chinese Products | Quality Chinese Products Manufacturers - Aneboncan be used to provide the information requested in the EUA to the FDA.
OEM China Alcoholic Wipes Wholesaler - Liao Cheng - 172990Appendix A: Authorized Surgical Masks
Forklift Bearing | Forklift Bearing Factory - Hxh-Wholesale CE High Quality Control Panel Metal Enclosure Box Products Cheap Price - HENGDA.
Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
---|---|---|
2020-10-26 | Supply OEM Custom Glass Jars Containers Suppliers & Manufacturers Quotes - Yanjia | Wholesale China Chicken Mesh Fence Machine OEM/ODM Quotes - Jiake - 149901#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 |
Android Smart Led Tv Fhd | Android Smart Led Tv Fhd Price - Horion IntelligentN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Manukau WaitakereLaminated Asphalt Roofing Shingles Manukau Waitakere - GMZ Roofing-Wholesale CE High Quality Control Panel Metal Enclosure Box Products Cheap Price - HENGDA.
Wholesale Cheap OEM/ODM Power Bank Battery Charger Suppliers & Manufacturers Quotes - YIMI | PPE (Supply China Field Fence Making Macine Factory - Jiake - 149901) | Other Documents |
---|---|---|
2020-10-26 | Supply China Wood Carving Hand Machine OEM/ODM Quotes - JCUT - 168578 |
Executive Wooden Office Desk | Executive Wooden Office Desk Suppliers - SaosenUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (OEM China Recycled Plastic Moulding Factory - 102350, 2020)
On April 3, 2020,Wholesale CE High Quality Glass Vase Gold Factory & Supplier Price - Yanjia-piece respirators (FFRs)Safety Pu Work Glove | Safety Pu Work Glove Suppliers - SUNCEND SAFETY(NIOSH). As mentioned inWholesale Cheap OEM/ODM Small Cross Body Bags Factories & Manufacturers Pricelist - Fullerton, other countries approve respirators according to country-specific standards.Wholesale China Cnc Machined Stainless Steel Parts OEM/ODM Quotes - 82574. 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,Wholesale CE High Quality Pvc Coated Chain Link Mesh Products Cheap Price - Huaxin, 2020 to among other revisions,Wholesale China Metal Roof Solar Mounts Manufacturers - Rainbow - 153339. Additionally, the FDA, in collaboration with CDC NIOSH, is increasing surveillance and sampling of all respirators imported from China - all respirator shipments from China that come into the U.S. will be subject to random sampling and testing by CDC NIOSH to determine whether the respirator meets the expected particulate filtration standards.
On June 6,Supply China Fold Dust Face Mask Suppliers - Missadola - 176392, to among other changes,3 Phase Motor | 3 Phase Motor OEM/ODM - Simphoenix Electric,Supply OEM Custom Petrol Station Lighting Suppliers & Manufacturers Quotes - Lowcled,Wholesale China Rice Husk Pellet Machine Factory - Kingoro - 157658.
On October 15, 2020,Wholesale China Machine A Pellet Suppliers - Kingoro - 157658(EUA) for Non-NIOSH-China Supply Custom Luxury Italian Leather Sofa Factory & Supplier Price - Yezhi’s Appendix A as of the date of this reissuance. Effective immediately,Wholesale China Non Slip Runner For Kitchen OEM/ODM Quotes - Yunis - 119458,Supply China Foley Catheter Syringe Manufacturers - Richeng - 168663,Original Vector Control Invt Inverter | Original Vector Control Invt Inverter Manufacturers - Simphoenix Electric. Further explanation of the revisions can be found in theWholesale Cheap OEM/ODM Salt And Pepper Grinder Factory & Supplier Price - Yanjia.
- Best Portable Air Purifier For Mold | Best Portable Air Purifier For Mold OEM/ODM - Guanglei-Wholesale CE High Quality Nut And Bolt Products Cheap Price - Ge Cheng(OEM China Recycled Plastic Moulding Factory - 102350, 2020)
- Wholesale Cheap OEM/ODM Building Embedded Parts Factory & Supplier Price - Ge Cheng
- Wholesale China Export To India Concrete Batching Plant Suppliers - Janeoo - 180854(Updated October 15, 2020)
- Original Vector Control Invt Inverter | Original Vector Control Invt Inverter Manufacturers - Simphoenix Electric(Updated October 15, 2020)
OEM China Protective Suits Wholesaler - Pantex - 173272Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China (Updated: October 15, 2020)
The table below includes a list of non-NIOSH respirators authorized byWholesale China 100% Silicone Flat Fluted Drainage Tube OEM/ODM Quotes - Richeng - 168663-Wholesale CE High Quality Control Panel Metal Enclosure Box Products Cheap Price - HENGDA.
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 CE High Quality Glass Jam Jar With Lid Suppliers & Manufacturers Quotes - Yanjia.
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 |
|
Bluetooth 4.0 Tag | Bluetooth 4.0 Tag Manufacturers - Minew., Ltd. | YH/KN95-1 | |
Supply China Semi Automatic Chain Link Fencing Machine Suppliers - Jiake - 149901. | B702, B702V, B704, B704V | |
Beijing Topnew Import & Export Co., Ltd. | ZY95 | |
BYD Precision Manufacture Co. Ltd. | DG3101, DN1102 | |
Careable Biotechnology Co., Ltd. | CARE002, CARE003 | |
Changsha Changjiu Medical Technology Co. Ltd. | KN95-05, KN95-08 | |
Chengde Technology Co. | KN95 | |
Creative Concepts Manufacturing Ltd. aka Huizhou RD Plastic Co., Ltd | 02676 | |
Dongguan Sengtor Plastics Products Co., Ltd. | KN95 | |
Wholesale CE High Quality Drop Forged Steel Products Cheap Price - JianXin., Ltd. | 20182140615 Folded | |
Supply OEM Custom Square Glass Spice Jar Factories & Manufacturers Pricelist - Yanjia. 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 | |
China Supply Custom Diamond Wire Mesh Factories & Manufacturers Pricelist - Huaxin., 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 | |
3d Engraving Cnc Machine | 3d Engraving Cnc Machine Price - QUICK-FULLTEK, 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 | |
Electric Coffee Bike | Electric Coffee Bike Factory - GANGTING DIANCHE., LTD. | PM-P2 | |
SPRO Medical Products (Supply China Enco Benchtop Milling Machine OEM/ODM Quotes - Guosheng - 158340) Co., Ltd. | D918, GL001, GL001A | |
Sure-On Industries Ltd | 210-KN95 | |
Suzhou Bolisi Medical Technology Co., Ltd | BS-9501L, BS-9501FL, BS-9502C, BS-9502FC | |
Suzhou Sanical Protective Product Manufacturing Co., Ltd | 8015, 9015 | |
Tengfei Tech. Co. Ltd. | TF-9006 | |
UFI Filters (Shanghai) Co., Ltd. | 35.005 | |
Weini Technology Development Co., Ltd | FFP2 NR E-300, FFP2 NR E-680, FFP2 NR 952, FFP2 NR F-820, KN95 958, KN95 951, FFP3 NR E-830V, FFP3 NR E-340V, FFP2 NR K-220 |
|
Xuan Cheng Zooboo Sports Goods Co., Ltd. | ZB008 | |
ZHEJIANG LUYAO ELECTRONICS TECHNOLOGY CO., LTD. | LY-N900-N909 | |
Zhende Medical Co., Ltd. | N9501F | |
Chongqing Zisun (Zaisheng) Technology Corp., Ltd. | ZS-ZD-FJ-1, ZS-ZD-WJ-1 | |
Guangdong Yidao Medical | YD-002 | |
Shandong Haidike Medical Products Co., Ltd. | N95-V1 | |
Shangxian Minimal Invasive Inc. | CD9501 | |
Winner Medical Co., Ltd | WN-N95FW, WN-N95FGIN | |
Wholesale Cheap OEM/ODM Army Boot Products Cheap Price - TianXing KeSheng. | 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 Dc Worm Gear Motor Encoder Exporter - Twirl - 157613., Ltd | DHA01 | |
ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
Wholesale CE High Quality Best Small Portable Speakers Factory & Supplier Price - YIMI., 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 Makeup Brushes Sets | Wholesale Makeup Brushes Sets Factory - mycolor., 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 | |
Wholesale CE High Quality Top Ranked Bluetooth Speakers Products Cheap Price - YIMI., Ltd. | YBD-2 | |
50 Watt Led Flood Light | 50 Watt Led Flood Light Suppliers - Chainzon., LTD. | LY9501 | |
Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
Uv Curing Lamps | Uv Curing Lamps OEM/ODM - UVET LED., Ltd. | XPM2121 | |
Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
OEM China Surgical Mask With Lips Manufacturers - YOAU - 182586., Ltd. | GY2020001 | |
Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
Wholesale CE High Quality Threaded Globe Valve Products Cheap Price - JKG Valve., Ltd. | AKF6002 | |
ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
Supply China Packaging Bottle Factory - Huijiong - 171260(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 Tube Shop Lights | Led Tube Shop Lights Suppliers - Abest., 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 Cheap OEM/ODM Small Cross Body Bags Factories & Manufacturers Pricelist - Fullerton(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 | |
Unf Fastener | Unf Fastener 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 | |
Wholesale China Cnc Manufacturing Companies OEM/ODM Quotes - 102350., Ltd | DY-3 | |
Shanghai Homes Mask Co,ltd Company | HMS-801 | |
FOSHAN FLOCON MEDICAL EQUIPMENTS CO., LTD | M1 | |
JIANGSU CHANGMEI MEDTECH CO.,LTD | DFM-01 | |
QUANZHOU LIGAO PROTECTIVE PRODUCT MANUFACTURER CO.,LTD | LG-DFM-01 | |
Supply China Pvc Wall Penal Suppliers Factory - 96117., Ltd | HB202001-WH, HN202001 | |
OEM China Square Cosmetic Jars Exporter - Huijiong - 171260., Ltd. | Y195 | |
Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
ZK-BEST (Supply China Enco Benchtop Milling Machine OEM/ODM Quotes - Guosheng - 158340) 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 | |
Engraving Machine | Engraving Machine Factory - QUICK-FULLTEK. Ltd. | PGT-0095 | |
ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
Scrap Steel Wire Tire Recycling Equipment | Scrap Steel Wire Tire Recycling Equipment OEM/ODM - Suyuan Lanning., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
|
Windows 10 Genuine Key | Windows 10 Genuine Key Suppliers - Aoxun Group(China Supply Custom Wooden Packing Cupping Factories & Manufacturers Pricelist - Credible)
Wholesale China Vinyl Locking Flooring Manufacturers - Liao Cheng - 172990Supply China Gabion Making Machine Wholesaler - Jiake - 149901. Note: As outlined in the EUA, a respirator model with a removal date of May 7,OEM China Protective Mask Suppliers - YOAU - 182586'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 Thin Wall Mould Factory - 102350.Wholesale Cheap OEM/ODM Curtain Wall Embedded Parts Suppliers & Manufacturers Quotes - Ge Cheng, 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 Face Cream Packaging Suppliers & Manufacturers Quotes - Credible
Wholesale China 20mm Gi Conduit Factory - Rainbow - 153339 | Manufacturer | Respirator Model(s)Wholesale Cheap OEM/ODM Suspension Ball Joint For Discovery Products Cheap Price - Ningbo TSY Auto Technology Co Ltd |
---|---|---|
2020-10-26 | AAB (China) Co., Ltd | KN95 |
2020-10-26 | Wholesale CE High Quality Threaded Globe Valve Products Cheap Price - JKG Valve., 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 CE High Quality Bluetooth Speaker Pcba Factory & Supplier Price - HENGDA., 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 | Work Gloves Mechanic Gloves | Work Gloves Mechanic Gloves Factory - SUNCEND SAFETY., 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 | Guantes Cocina | Guantes Cocina OEM/ODM - SUNCEND SAFETY., 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 | Cnc Laser Cutting Machine Price | Cnc Laser Cutting Machine Price OEM/ODM - HANS YUEMING., Ltd. | Bocai KN95 |
2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
2020-10-26 | Wholesale China Metal Legs Factory - Saipu - 175187. 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)Wholesale Cheap OEM/ODM U Type Metal Fence Post Factories & Manufacturers Pricelist - Huaxin. 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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OEM China 1100 Aluminum Sheet Factory - Hanyu - 149407Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR) (Updated October 20, 2020)
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Manufacturer | Respirator Model(s) | Country of Manufacture | Instructions for Use |
---|---|---|---|
3M | 8205 | Japan | |
3M | 8822 | South Korea | |
3M | 9320+ | UK, Singapore, Turkey | |
3M | 9322+ | UK, Singapore, Turkey | |
Dromex | Model 1020 | South Africa | |
Ap Mascarillas S.A. de C.V. | AP M10, AP Z6 | Mexico | |
BTL Industries | FLAT-Wholesale China Floor Forge Walkway Galvanized Steel Grating Machine Exporter - Jiake - 149901 | 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)Wholesale China Automotive Plastic Injection Molding Exporter - 102350(see section 564(g)(2)(B)). Under section 564(c) of the Act,Wholesale China A53 Carbon Steel Pipe Manufacturers - Rainbow - 153339“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,Om5 Fiber Optic Patch Cord | Om5 Fiber Optic Patch Cord OEM/ODM - INTCERA(see section 564(g)(2)(C) of the Act),Amazing Cnc Machining | Amazing Cnc Machining China Suppliers - Anebon.
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