Personal Protective Equipment EUAs
Wholesale China Tea Chair Factory - 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.
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Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anCnc Wood Drilling Machine | Cnc Wood Drilling Machine Manufacturers - QUICK-FULLTEK. Additionally, the FDA has posted aWall Cutting Saw Bladeof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
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Wholesale China Concrete Batching Plant With Mixer Wholesaler - Janeoo - 180854Umbrella EUA for Surgical Masks
On August 5, 2020,Supply OEM Custom Motorized Valve Suppliers & Manufacturers Quotes - JKG Valve(EUA) for certain disposable, single-Wholesale Cheap OEM/ODM Wifi Control Module Pcb Assembly Products Cheap Price - HENGDA.Tool Cutter | Tool Cutter Suppliers - Millcraft Tools-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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TheVeterinary Pharmaceutical Companiescan be used to provide the information requested in the EUA to the FDA.
Wholesale Cheap OEM/ODM Nasal Scope Factory & Supplier Price - TITMEDAppendix A: Authorized Surgical Masks
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Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
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2020-10-26 | Buy Cheap Best Maxx Coating NZ New Zealand - GMZ Roofing | Wholesale China Round Drainage Tube OEM/ODM Quotes - Richeng - 168663#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 |
Supply China Glass Sports Bottle Exporter - Hoyer - 175219N95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Laser Cutter Wood Cutting Machine | Laser Cutter Wood Cutting Machine OEM/ODM - Ruijie-Wholesale Cheap OEM/ODM Hot Rolled H Channel Factory & Supplier Price - Ge Cheng.
China Supply Custom Mechanical Parts Factory & Supplier Price - JianXin | PPE (Thrust Ball Bearing Skf | Thrust Ball Bearing Skf Price - Hxh) | Other Documents |
---|---|---|
2020-10-26 | Wholesale China Mini Cnc Router Machine Manufacturers - JCUT - 168578 |
Cnc Mini Engraver | Cnc Mini Engraver Factory - QUICK-FULLTEKUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Office Track Lighting | Office Track Lighting Price - Abest, 2020)
On April 3, 2020,Wholesale Cheap OEM/ODM Agricultural Post Products Cheap Price - Huaxin-piece respirators (FFRs)OEM China Foaming Soap Bottles Bulk Exporter - Huijiong - 171260(NIOSH). As mentioned inWholesale China Ultrasonic Machine Wholesaler - Shouzheng - 185528, other countries approve respirators according to country-specific standards.Supply China the patient lifter Factory - JBH Medical - 155649. 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 Fake Grass Carpet Outdoor Exporter - Yunis - 119458, 2020 to among other revisions,Supply China Grain Bagging Machine Exporter - Kingoro - 157658. Additionally, the FDA, in collaboration with CDC NIOSH, is increasing surveillance and sampling of all respirators imported from China - all respirator shipments from China that come into the U.S. will be subject to random sampling and testing by CDC NIOSH to determine whether the respirator meets the expected particulate filtration standards.
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Lazer Cutting | Lazer Cutting Suppliers - MORN LASERAppendix 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 byGuangxi University For Nationalities | Guangxi University For Nationalities Factory - Juntai-Wholesale Cheap OEM/ODM Hot Rolled H Channel Factory & Supplier Price - Ge Cheng.
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:Guantes Cuero | Guantes Cuero Price - SUNCEND SAFETY.
Manufacturer | Respirator Model(s) | Instructions for Use |
---|---|---|
3M | 9001, 9002, 9501, 9501+, 9501V+, 9502, 9502+, 9502V+, 9505+, 9541, 9541V, 9542, 9542V, 9552, 9552V |
|
Allmed Medical Products Co., Ltd | LP220002 | |
AOK Tooling Ltd. (aka Shenzhonghai Medical) | 20130040, 20130045A, 20180021, 20130038, 20190019, 910, 20190029 |
|
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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 Mini Cement Concrete Batch Plant Suppliers - Janeoo - 180854., Ltd. | 20182140615 Folded | |
5 Axis Cnc Wood Router | 5 Axis Cnc Wood Router OEM/ODM - QUICK-FULLTEK. 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 Ffp2 Mask Wholesaler - Yangtuo - 169136., 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 | |
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|
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 CE High Quality Facial Cupping Set Products Cheap Price - Credible., LTD. | PM-P2 | |
SPRO Medical Products (Wholesale China Rapid Machining OEM/ODM Quotes - 102350) 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 | |
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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 CE High Quality Glass Jar With Bamboo Cover Factory & Supplier Price - Yanjia., Ltd | DHA01 | |
ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
Wholesale Cheap OEM/ODM PVC Hoses Products Cheap Price - Ruichen Pneumatic., 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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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 | |
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Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
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Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
Wholesale China semi electric bed Suppliers - JBH Medical - 155649., Ltd. | GY2020001 | |
Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
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Jinyi (Tianjin) Medical Technology Co., Ltd. | JYKN9501 | |
Heyuan COE Communication Technology Co., Ltd. | CHMM-NB | |
Jinhua Ai Kou Protective Equipment Co., | AK003 | |
Jiangmen Nostop Electric Co., Ltd | JW-017 | |
YuTong Eco-Technology (SuQian) Co., Ltd | YT-07 | |
Dongguan City Outdoorsy Co., Ltd. | OD-001 | |
Guangdong Tengrui Pharmaceutical Technology Co., Ltd. | LSH-201 | |
Hunan Hengchang Pharmaceutical Co., LTD. | N9501-L (non-sterile type) | |
AnDum Protective Equipment Technology (Changzhou) Co.,Ltd. | AD-1001 | |
Beifa Anhui Manufacturing Co., Ltd. | BF-A-01 | |
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Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | |
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Yiyang Taihe Technology Co. Ltd | YTH0001 | |
Zhangzhou Easepal Industrial Co., Ltd. | D13003 and D13003AC | |
Zhejiang Langqi Fashion Co., Ltd | XJB902 | |
Zhejiang Yinda Biotechnology Co., Ltd. | YD-N2 | |
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Hui Zhou Tian Chang Industrial Co., Ltd. | N002-AW | |
Jingzhou Strong Sciences & Technology Development Co.,ltd | ST-A9502, A9507 | |
Lu’an Bi Hai Protective Equipment Co., Ltd. | BH2020 | |
Naton Medical Protective Mask (Zhuozhou) Co., Ltd | FS9501-L, FS9501-M, FS9501-S; FS9901-L, FS9901-M, FS9901-S | |
Deli Group Co., LTD. | ET30000 | |
DONGGUAN AOXING AUDIO VISUAL EQUIPMENT CO.,LTD | AX-KF95 | |
Guangdong Languan Medical Biotechnology Co., Ltd. | LGKN95 | |
Wuhan Zonsen Medical Products Co., Ltd. | ZSFM-01, ZSFM-02 | |
Zhejiang Dongmeng Medical Equipment Co., LTD | EYTV139110051-02 | |
Regina Miracle (Shenzhen) Ltd. | RM2020 MA-08 | |
Violet Home Textile Technology Co., Ltd. | ZLL377 | |
Guangdong Willing Technology Corporation | WL-01 | |
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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 | |
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Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
ZK-BEST (Wholesale China Rapid Machining OEM/ODM Quotes - 102350) Environmental Science & Technology Co., Ltd. | ZKG9501, ZKG9501V | |
Guangxi MC Medical equipment Co., Ltd | MC010501 | |
Hunan EEXI Technology & Service Co., Ltd. | YX152, YX153 | |
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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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Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
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Laser Wood Engraving Machine | Laser Wood Engraving Machine Factory - MORN LASERWholesale Cheap OEM/ODM Unbreakable Wine Glass Cups Suppliers & Manufacturers Quotes - Yanjia. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Wholesale CE High Quality Vacuum Suction Cup Factories & Manufacturers Pricelist - Credible's Standard Test Procedure (STP) TEB-APR-STP-0059 within 45 calendar days of May 7, 2020, and has results of NIOSH testing that indicate a minimum and maximum filtration efficiency greater than or equal to 95 percent. Respirators with removal dates after May 7,Office Table | Office Table Factory - Saosen.7003c Bearing | 7003c Bearing OEM/ODM - Hxh, 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:Textile Fiber Laser Cutting Machine | Textile Fiber Laser Cutting Machine Factory - MORN LASER
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2020-10-26 | AAB (China) Co., Ltd | KN95 |
2020-10-26 | Shanghai LeadCloud Tech Co., Limited is fraud company - Contact me for more whatsapp: 7700053089., LTD | AKF2002 |
2020-10-26 | Bei (Dong Shan) Protective Supplies Co., LTD | B707 |
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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 |
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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 China standing lifter Suppliers - JBH Medical - 155649., Ltd | KN95 |
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2020-10-26 | Guangzhou Aiyinmei Co., LTD | A&F KN95 |
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2020-10-26 | Guangzhou Yihere Medical Technology Development Co., Ltd | YH-MFK-B95, YH-MFK-Z95 |
2020-10-26 | 12 Fiber Om4 Patch Cord | 12 Fiber Om4 Patch Cord OEM/ODM - TTI Fiber., Ltd. | Bocai KN95 |
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2020-10-26 | OEM China Antique Wooden Plant Stands Indoor Suppliers - Aj Union - 149916. 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)3.5mm Aux Cable | 3.5mm Aux Cable China Suppliers - CableCreation. Ltd | KN95 |
2020-10-26 | Panzhihua Gangcheng Group Yasheng Industrial Co., Ltd. | KN95 |
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2020-10-26 | Qingyuan Leite Technology Development Co. | GV-0095A, GVHKN95 |
2020-10-26 | Shandong Daddy'Supply OEM Custom Amber Bottle Glass Products Cheap Price - Credible., Ltd | Purism KN95 |
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OEM China Pvc Composite Wall Cladding Outdoor Exporter - 96117Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (Supply OEM Custom Glass Honey Jar With Wooden Lid Factory & Supplier Price - Yanjia, 2020)
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Cnc Machining Prototype Service | Cnc Machining Prototype Service China Suppliers - AnebonExhibit 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 |
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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 | |
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Galia Textil S.A. DE C.V | GTN95 | Mexico | |
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OEM China Precision Milling Parts Suppliers - 82574Face Shields and Other Barrier EUAs
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China Supply Custom Mechanical Parts Factory & Supplier Price - JianXin | PPE (Thrust Ball Bearing Skf | Thrust Ball Bearing Skf Price - Hxh) | Other Documents |
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