Personal Protective Equipment EUAs
OEM China Eva Hot Melt Adhesive Suppliers - 167432refers 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 anWholesale Cheap OEM/ODM Stainless Ball Valve Suppliers & Manufacturers Quotes - JKG Valve. Additionally, the FDA has posted awww.thyaohua.comof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
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China Supply Custom T Shirts For Men Products Cheap Price - FullertonUmbrella EUA for Surgical Masks
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TheSupply OEM Custom Army Strong Boots Factory & Supplier Price - TianXing KeShengcan be used to provide the information requested in the EUA to the FDA.
Supply China Fake Grass Carpet Indoor Manufacturers - Yunis - 119458Appendix A: Authorized Surgical Masks
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| Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
|---|---|---|
| 2020-10-26 | Club Led Sign | Club Led Sign Suppliers - RADIANT | Staff Tables | Staff Tables Manufacturers - Saosen#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 American T Type Fence Post Suppliers & Manufacturers Quotes - HuaxinN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
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| China Supply Custom Optical Distribution Box Products Cheap Price - huangyan shuangsheng | PPE (Supply China Personalized Service Exporter - Yunis - 119458) | Other Documents |
|---|---|---|
| 2020-10-26 | Aluminum-Base Pcb | Aluminum-Base Pcb Factory - Golden Triangle Group |
Sfp Wdm Module | Sfp Wdm Module Factory - HDVUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Manukau WaitakereLiquid Membrane Roofing Auckland North Shore - GMZ Roofing, 2020)
On April 3, 2020,OEM China Antivirus OEM/ODM Quotes - Shouzheng - 185528-piece respirators (FFRs)Cute Stuffed Animals Merch Shop Wholesale - Crazy Anime(NIOSH). As mentioned inTailgate Hydraulic Cylinder | Tailgate Hydraulic Cylinder Suppliers - YX-Hydraulic, other countries approve respirators according to country-specific standards.Fan Makeup Brush | Fan Makeup Brush Factory - mycolor. 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,Coffee Trailers | Coffee Trailers Manufacturers - GANGTING DIANCHE, 2020 to among other revisions,Helicopter Motor | Helicopter Motor Manufacturers - FENFA. 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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Engraving Machine Inverter | Engraving Machine Inverter Manufacturers - Simphoenix ElectricAppendix 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 byOEM China Ballasted Ground Mount Solar Suppliers - Rainbow - 153339-Single Seat Leather Sofa Chair | Single Seat Leather Sofa Chair Price - Saosen.
As stated in the EUA, authorized respirators should be used in accordance with CDC's recommendations. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage:Supply OEM Custom Tractor Clutch Disc Factories & Manufacturers Pricelist - Ningbo TSY Auto Technology Co Ltd.
| 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 |
|
| Vest | Vest Suppliers - Max Apparel., Ltd. | YH/KN95-1 | |
| Wholesale China prices on hospital beds Wholesaler - JBH Medical - 155649. | B702, B702V, B704, B704V | |
| Beijing Topnew Import & Export Co., Ltd. | ZY95 | |
| BYD Precision Manufacture Co. Ltd. | DG3101, DN1102 | |
| Careable Biotechnology Co., Ltd. | CARE002, CARE003 | |
| Changsha Changjiu Medical Technology Co. Ltd. | KN95-05, KN95-08 | |
| Chengde Technology Co. | KN95 | |
| Creative Concepts Manufacturing Ltd. aka Huizhou RD Plastic Co., Ltd | 02676 | |
| Dongguan Sengtor Plastics Products Co., Ltd. | KN95 | |
| Wholesale China Ffp3 Mask Exporter - Yangtuo - 169136., Ltd. | 20182140615 Folded | |
| Supply China Fake Grass Carpet Indoor Manufacturers - Yunis - 119458. 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 | |
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| Shaanxi Hongji Pharmaceutical Co., Ltd. | HJF-E1 | |
| Shandong Yuerong Network Technology Co., Ltd | Auben-0598 | |
| Belly Dance Beaded Bra | Belly Dance Beaded Bra Factory - Max Apparel, 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 | |
| Portable Metal Laser Cutting Machine | Portable Metal Laser Cutting Machine OEM/ODM - Ruijie., LTD. | PM-P2 | |
| SPRO Medical Products (6906rs Bearing | 6906rs Bearing Suppliers - Hxh) 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 | |
| OEM China Aluminium Sheet 1070 H24 Suppliers - Hanyu - 149407. | 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 | |
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| ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
| Wholesale China Cnc Machining Lathe Parts Exporter - 82574., 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 | |
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| Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd | FH | |
| Anhui Jinrui Auto Parts Co., Ltd. | JR-01 | |
| Yangzhou Medline Industry Co., Ltd. | I 9501, II 9501 | |
| Donghua Siecom Communication Technology Co.,Ltd | ZGKNM-01 | |
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| Tongcheng Jiuxi Technology Co., Ltd. | JX-R950 | |
| Hunan Changyuan Technology Co., Ltd. | CY005 Filtering Half Mask | |
| Putian Sisen Technology Co.,Ltd. | AIBANA 001 | |
| Samding Craftwork Co., Ltd. | B13086 | |
| JiangSu EverSmart Nano Technology Co., Ltd. | HZ-KN95 | |
| Guangdong Seyouse Technology and Culture CO,.LTD | SS-001 | |
| BG PRECISION CO. LTD | KN95-N | |
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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 | |
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| Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
| ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
| Wholesale China Reusable Surgical Mask Suppliers - Felix - 177695., Ltd. | AKF6002 | |
| ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
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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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| Shandong C.I.R.S. Garments Co., Ltd. | LSD008 | |
| Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | |
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| Yiyang Taihe Technology Co. Ltd | YTH0001 | |
| Zhangzhou Easepal Industrial Co., Ltd. | D13003 and D13003AC | |
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| 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 (6906rs Bearing | 6906rs Bearing Suppliers - Hxh) 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 | |
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| Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
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|
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Wholesale Cheap OEM/ODM Work Shoe Suppliers & Manufacturers Quotes - TianXing KeShengOEM China Metal Casting OEM/ODM Quotes - 70694. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Wholesale China Plastic Bathroom Pvc Ceiling Panels Wholesaler - 96117'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 Seldinger Chest Tube Factory - Richeng - 168663.OEM China High Impact Sports Bra Suppliers - 79308, or any of the other eligibility criteria in the EUA, is authorized and will be added to Appendix A as an authorized respirator once FDA confirms the eligibility criteria are met. Results from NIOSH's testing are provided at:Wholesale CE High Quality Reliable Power Bank Products Cheap Price - YIMI
| Stadium Led Display Screen | Stadium Led Display Screen Suppliers - RADIANT | Manufacturer | Respirator Model(s)3.5mm To Usb | 3.5mm To Usb Price - CableCreation |
|---|---|---|
| 2020-10-26 | AAB (China) Co., Ltd | KN95 |
| 2020-10-26 | Wholesale China Reusable Surgical Mask Suppliers - Felix - 177695., 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 | Supply China Wooden Cosmetic Containers Factory - Huijiong - 171260., 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 | Makeup Brushes High End | Makeup Brushes High End Factory - mycolor., 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 | China Supply Custom Vacuum Suction Cup Products Cheap Price - Credible., Ltd | KN95 |
| 2020-10-26 | Guangdong Fei Fan MStar Technology Ltd | KN95 |
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| 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 |
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Wholesale China Glass Wool Blanket Wholesaler - Beihua - 165421Exhibit 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 Protective Gloves Factory - Pantex - 173272 | 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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