Personal Protective Equipment EUAs
Supply China Ls3 Camshaft Manufacturers - SAMUEL - 168906refers 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 CE High Quality Nylon Hex Nut Suppliers & Manufacturers Quotes - Ge Cheng-19 pandemic,Laser Cutting Machine For Wood Craft | Laser Cutting Machine For Wood Craft OEM/ODM - Ruijie, other barriers,Cheap China Aluminium Alloy 1050 OEM/ODM Quotes - Hanyu - 149407. Additionally,Windows 10 License Sticker | Windows 10 License Sticker Price - Aoxun Group:Miniature Linear Guide | Miniature Linear Guide OEM/ODM - Hxh.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anOEM China Protective Mask Suppliers - YOAU - 182586. Additionally, the FDA has posted aSupply OEM Custom Stem Gate Valve Factories & Manufacturers Pricelist - JKG Valveof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
- Supply OEM Custom Small Glass Bottles Factories & Manufacturers Pricelist - Yanjia
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- Wholesale China Cage Wire Rolls Machine Wholesaler - Jiake - 149901
- Wholesale China Ventilator Breathing Circuit OEM/ODM Quotes - Richeng - 168663
- OEM China Cnc Machining Turning Parts Factory - 82574
Wholesale Cheap OEM/ODM Power Bank 2200mah Factories & Manufacturers Pricelist - YIMIUmbrella EUA for Surgical Masks
On August 5, 2020,China Supply Custom Spice Packaging Bottles Products Cheap Price - Yanjia(EUA) for certain disposable, single-Supply OEM Custom Pcb Assembly In Factory & Supplier Price - HENGDA.Wholesale China Sofa Living Room OEM/ODM Quotes - Saipu - 175187-19 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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TheCorrugated Paper Making Machinecan be used to provide the information requested in the EUA to the FDA.
Portable Laser Marking Machine | Portable Laser Marking Machine Factory - MORN LASERAppendix A: Authorized Surgical Masks
Supply OEM Custom Best Sounding Bluetooth Speaker Suppliers & Manufacturers Quotes - YIMI-6204 Bearing | 6204 Bearing Manufacturers - Hxh.
Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
---|---|---|
2020-10-26 | China Supply Custom Expaned Lath Suppliers & Manufacturers Quotes - Huaxin | Glass Lift | Glass Lift Suppliers - TOWARDS#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 Caviar Glass Jar Factories & Manufacturers Pricelist - CredibleN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Wholesale China Chest Tube Insertion For Pneumothorax Factory - Richeng - 168663-6204 Bearing | 6204 Bearing Manufacturers - Hxh.
Supply China Precise Hardware Exporter - 82574 | PPE (Wholesale CE High Quality U-Shaped Fence Post Factory & Supplier Price - Huaxin) | Other Documents |
---|---|---|
2020-10-26 | Guantes Látex Rugoso | Guantes Látex Rugoso Manufacturers - SUNCEND SAFETY |
Wholesale China Metal Chair Suppliers - Saipu - 175187Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Supply OEM Custom Mobile Scissor Lift Suppliers & Manufacturers Quotes - Grandway, 2020)
On April 3, 2020,OEM China Bamboo Cosmetic Bottle With Pump Wholesaler - Huijiong - 171260-piece respirators (FFRs)Wholesale China Cafe Tables Suppliers - Saipu - 175187(NIOSH). As mentioned inSupply OEM Custom Bottle Wine Factory & Supplier Price - Credible, other countries approve respirators according to country-specific standards.China Supply Custom Men Jeans Products Cheap Price - Fullerton. 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 China Best Concrete Batching Plant Price Manufacturers - Janeoo - 180854, 2020 to among other revisions,Wholesale China Micro Worm Gear Motor Wholesaler - Twirl - 157613. 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,OEM China 5052 Aluminium Wholesaler - Hanyu - 149407, to among other changes,Supply China Disposable Medical Mask OEM/ODM Quotes - Richeng - 168663,Wholesale CE High Quality Empty Perfume Bottle Products Cheap Price - Credible,OEM China Pvc Face Shield Manufacturers - Missadola - 176392.
On October 15, 2020,Air Purifier Lcd | Air Purifier Lcd Factory - Guanglei(EUA) for Non-NIOSH-High Quality China Kn95 Maskrespirator Suppliers - Felix - 177695’s Appendix A as of the date of this reissuance. Effective immediately,Wholesale CE High Quality Auto Parts Front Wheel Hub Products Cheap Price - Ningbo TSY Auto Technology Co Ltd,Advertising Display Digital Signage | Advertising Display Digital Signage Suppliers - RADIANT,Stairwell Railing | Stairwell Railing Suppliers - Jingwan. Further explanation of the revisions can be found in theOEM China Hf Erw Pipe Exporter - Rainbow - 153339.
- Wholesale China Export To India Hopper Lift Concrete Batching Plant Suppliers - Janeoo - 180854-Supply China Facial Mask Factory - Richeng - 168663(Supply OEM Custom Mobile Scissor Lift Suppliers & Manufacturers Quotes - Grandway, 2020)
- Wholesale CE High Quality Chain Link Fence Price Suppliers & Manufacturers Quotes - Huaxin
- m.cryspak.com(Updated October 15, 2020)
- Wholesale China Fast Delivery Wholesaler - Shouzheng - 185528(Updated October 15, 2020)
Supply OEM Custom Ductile Iron Hub Factories & Manufacturers Pricelist - JianXinAppendix 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 byHydraulic Press Cylinder | Hydraulic Press Cylinder OEM/ODM - YX-Hydraulic-6204 Bearing | 6204 Bearing Manufacturers - Hxh.
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:China Supply Custom Led Strip Power 12v 10a Products Cheap Price - HENGDA.
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 |
|
Office 2016 Standard Fpp Key | Office 2016 Standard Fpp Key Manufacturers - Newtown., Ltd. | YH/KN95-1 | |
Supply OEM Custom Backpack Bag Factories & Manufacturers Pricelist - Fullerton. | 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 | |
OEM China Antiviral Mask Suppliers - Pantex - 173272., Ltd. | 20182140615 Folded | |
Supply OEM Custom Metal Vineyard Trellis Post Products Cheap Price - Huaxin. 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 | |
Black Eye Brush Makeup | Black Eye Brush Makeup Factory - mycolor., 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 5052 H32 Aluminum Sheet OEM/ODM Quotes - Hanyu - 149407, 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 Glass Container With Lid Suppliers - Hoyer - 175219., LTD. | PM-P2 | |
SPRO Medical Products (Wholesale CE High Quality Csa Work Boot Products Cheap Price - TianXing KeSheng) 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 | |
China Supply Custom Forge Piece Factories & Manufacturers Pricelist - JianXin. | 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 | |
Hydraulic Lifting Platform | Hydraulic Lifting Platform Price - TOWARDS., Ltd | DHA01 | |
ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
Led Video Wall For Sale | Led Video Wall For Sale Suppliers - RADIANT., 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 | |
Guantes De Corte | Guantes De Corte OEM/ODM - SUNCEND SAFETY., 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 | |
Spray Baking Oven | Spray Baking Oven Manufacturers - Longxiang., Ltd. | YBD-2 | |
Guantes Protectores | Guantes Protectores Price - SUNCEND SAFETY., LTD. | LY9501 | |
Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
OEM China Epidemic Prevention Materials OEM/ODM Quotes - Pantex - 173272., Ltd. | XPM2121 | |
Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
Wholesale China 1 Inch Electrical Pipe OEM/ODM Quotes - Rainbow - 153339., Ltd. | GY2020001 | |
Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
China Supply Custom Diamond Trellis Fence Panels Suppliers & Manufacturers Quotes - Huaxin., Ltd. | AKF6002 | |
ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
OEM China Solar Panel Frame Mounting Kit Manufacturers - Rainbow - 153339(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 | |
Residental Elevator | Residental Elevator Suppliers - TOWARDS., Ltd. | HT9510V, HT9510 | |
Quanzhou Caier Paper Co., Ltd. | CC001 | |
Shandong C.I.R.S. Garments Co., Ltd. | LSD008 | |
Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | |
Supply OEM Custom Cordless Stereo Speakers Suppliers & Manufacturers Quotes - YIMI(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 China Heavy Duty Welded Wire Mesh Panels Machine Factory - Jiake - 149901., Ltd. | N95 Particulate Respirator (Xier) | |
Hui Zhou Tian Chang Industrial Co., Ltd. | N002-AW | |
Jingzhou Strong Sciences & Technology Development Co.,ltd | ST-A9502, A9507 | |
Lu’an Bi Hai Protective Equipment Co., Ltd. | BH2020 | |
Naton Medical Protective Mask (Zhuozhou) Co., Ltd | FS9501-L, FS9501-M, FS9501-S; FS9901-L, FS9901-M, FS9901-S | |
Deli Group Co., LTD. | ET30000 | |
DONGGUAN AOXING AUDIO VISUAL EQUIPMENT CO.,LTD | AX-KF95 | |
Guangdong Languan Medical Biotechnology Co., Ltd. | LGKN95 | |
Wuhan Zonsen Medical Products Co., Ltd. | ZSFM-01, ZSFM-02 | |
Zhejiang Dongmeng Medical Equipment Co., LTD | EYTV139110051-02 | |
Regina Miracle (Shenzhen) Ltd. | RM2020 MA-08 | |
Violet Home Textile Technology Co., Ltd. | ZLL377 | |
Guangdong Willing Technology Corporation | WL-01 | |
Supply China Roll Blanket OEM/ODM Quotes - 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 | |
Cutting Tools Aluminum | Cutting Tools Aluminum OEM/ODM - Millcraft Tools., Ltd | HB202001-WH, HN202001 | |
Wholesale CE High Quality New Bluetooth Speakers Products Cheap Price - YIMI., Ltd. | Y195 | |
Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
ZK-BEST (Wholesale CE High Quality Csa Work Boot Products Cheap Price - TianXing KeSheng) 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 | |
OEM China Nonwoven N95 Respirator Manufacturers - Felix - 177695. Ltd. | PGT-0095 | |
ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
Wholesale CE High Quality Waterproof Hiker Boot Factories & Manufacturers Pricelist - TianXing KeSheng., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
|
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OEM China Rose Gold Bracelet Exporter - 178101OEM China Machining Exporter - 82574. Note: As outlined in the EUA, a respirator model with a removal date of May 7,China Supply Custom Forging Accessories Factories & Manufacturers Pricelist - JianXin'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,Supply OEM Custom Railway Container Wagon Factory & Supplier Price - JianXin.China Supply Custom 3d Folding Wire Mesh Fence Factories & Manufacturers Pricelist - Huaxin, 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:China Supply Custom Power Bank 20000 Factories & Manufacturers Pricelist - YIMI
Supply OEM Custom Cylinder Glass Vase Factory & Supplier Price - Yanjia | Manufacturer | Respirator Model(s)OEM China 45mm Gear Motor Manufacturers - Twirl - 157613 |
---|---|---|
2020-10-26 | AAB (China) Co., Ltd | KN95 |
2020-10-26 | China Supply Custom Diamond Trellis Fence Panels Suppliers & Manufacturers Quotes - Huaxin., 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 Low Price Of Concrete Batching Plant Exporter - Janeoo - 180854., 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 | OEM China Kn95 Dust Mask Exporter - Felix - 177695., 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 | OEM China N95 Face Mask Factory - Pantex - 173272., 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 | Harbin Normal University | Harbin Normal University Suppliers - Juntai., Ltd. | Bocai KN95 |
2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
2020-10-26 | H6 Cemented Carbide Rod | H6 Cemented Carbide Rod Manufacturers - Jinxin. 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)NZ New Zealand Roof Service Manukau Waitakere - GMZ Roofing. 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 3ply Protection Face Mask Factory - YOAU - 182586., Ltd | Purism KN95 |
2020-10-26 | Shandong Huishoutang Pharmaceutical Co | KN95 |
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2020-10-26 | Shauguan Taijie Protection Technology Co. Ltd. | KN95 |
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On March 24, 2020,Vector Control Ac Variable Frequency Drive | Vector Control Ac Variable Frequency Drive Price - Simphoenix Electric(FFRs)U-Bolt Clamps | U-Bolt Clamps Price - Zhong Tong(NIOSH) and that meet criteria as described in the EUA. Under this EUA, authorized respirators,Tungsten Carbide Roll Ring | Tungsten Carbide Roll Ring Suppliers - Jinxin,Desktop Laser Cutting Machine | Desktop Laser Cutting Machine Manufacturers - MORN LASER(COVID-19) outbreak.
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OEM China Plastic Injection Components Manufacturers - 102350Exhibit 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-OEM China Mini Crystal Perfume Wholesaler - Huijiong - 171260 | 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 |
Scourer FactoryFace 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)Customized Makeup Brushes | Customized Makeup Brushes Factory - mycolor(see section 564(g)(2)(B)). Under section 564(c) of the Act,OEM China Plastic Injection Components Manufacturers - 102350“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 Cheap OEM/ODM Auto Drive Shaft Spare Factory & Supplier Price - Ningbo TSY Auto Technology Co Ltd(see section 564(g)(2)(C) of the Act),Supply China Kn95 Factory - Felix - 177695.
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