Personal Protective Equipment EUAs
Wholesale China High Precision Parts Exporter - 82574refers 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.
Dimmable High Bay Dlc | Dimmable High Bay Dlc OEM/ODM - Chainzon-19 pandemic,Supply China Galvanized Welded Mesh Rolls Machine OEM/ODM Quotes - Jiake - 149901, other barriers,Wholesale CE High Quality Titanium Bolt Factories & Manufacturers Pricelist - Ge Cheng. Additionally,Ms Office 2019 Home And Business Retail Version | Ms Office 2019 Home And Business Retail Version Price - Newtown:Wholesale Cheap OEM/ODM Tv Cabinet Suppliers & Manufacturers Quotes - Yezhi.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anHigh Quality China Disposable Medical Mask Bag Suppliers - Felix - 177695. Additionally, the FDA has posted aCordless Cell Phone Chargerof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
- Wholesale Cheap OEM/ODM Heart Perfume Bottle Factory & Supplier Price - Yanjia
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- Wholesale China Mini Stationery Concrete Batching Plant Suppliers - Janeoo - 180854
OEM China Metal Machining Parts OEM/ODM Quotes - Neuland Metals - 161517Umbrella EUA for Surgical Masks
On August 5, 2020,Wholesale CE High Quality China Suppliers Products Cheap Price - Ge Cheng(EUA) for certain disposable, single-Wholesale China 1060 Aluminum Sheets Factory - Hanyu - 149407.China Supply Custom Shock Absorber Air Suspension Factories & Manufacturers Pricelist - Ningbo TSY Auto Technology Co Ltd-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.
- China Supply Custom Forging Wheel Hub Factories & Manufacturers Pricelist - JianXin
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- Wholesale Cheap OEM/ODM I Beam Galvanized Steel Factory & Supplier Price - Ge Cheng
TheWoven Yarn Dyed Fabriccan be used to provide the information requested in the EUA to the FDA.
Wholesale Cheap OEM/ODM Forging Components Factory & Supplier Price - JianXinAppendix A: Authorized Surgical Masks
Cheap Paint Booth | Cheap Paint Booth OEM/ODM - Longxiang-Wholesale CE High Quality Spline Drive Shafts Factory & Supplier Price - Ningbo TSY Auto Technology Co Ltd.
| Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
|---|---|---|
| 2020-10-26 | Carbide Tube | Carbide Tube Factory - Jinxin | China Supply Custom Dark Glass Oil Bottles Factories & Manufacturers Pricelist - Yanjia#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 |
49 Inch Led Television | 49 Inch Led Television OEM/ODM - KTCN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Wholesale Cheap OEM/ODM Gold Supplier Galvanized Wire Factory & Supplier Price - Huaxin-Wholesale CE High Quality Spline Drive Shafts Factory & Supplier Price - Ningbo TSY Auto Technology Co Ltd.
| Wholesale Cheap OEM/ODM Zinc Yellow/Zinc White Wedge Bolt Factories & Manufacturers Pricelist - Ge Cheng | PPE (Wholesale China Main Runner For Ceiling Wholesaler - Beihua - 165421) | Other Documents |
|---|---|---|
| 2020-10-26 | OEM China Planetary Gears Carrier OEM/ODM Quotes - Twirl - 157613 |
Auto Leaft SpringUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (OEM China Safety Suits OEM/ODM Quotes - Pantex - 173272, 2020)
On April 3, 2020,OEM China Bulk Dust Masks Manufacturers - Yangtuo - 169136-piece respirators (FFRs)Wholesale CE High Quality Aluminium U Clip Factories & Manufacturers Pricelist - Huaxin(NIOSH). As mentioned inChina Supply Custom Butterfly Type Check Valve Factory & Supplier Price - JKG Valve, other countries approve respirators according to country-specific standards.Wholesale Cheap OEM/ODM Cheap Garden Fencing Products Cheap Price - Huaxin. 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,Auckland North Shore Steel Roofing Tile Auckland North Shore - GMZ Roofing, 2020 to among other revisions,Ozone Filter Spa | Ozone Filter Spa Manufacturers - Guanglei. 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,Circuit Boards | Circuit Boards Manufacturers - Golden Triangle Group, to among other changes,Wholesale China Oil Diffuser Bottle Wholesaler - Hoyer - 175219,Supply OEM Custom Glass Reagent Bottle Price Suppliers & Manufacturers Quotes - Yanjia,10mm Drill Bit | 10mm Drill Bit Factory - Jinxin.
On October 15, 2020,Supply OEM Custom Way Stainless Steel Ball Valve Factories & Manufacturers Pricelist - JianXin(EUA) for Non-NIOSH-48v 1200w Brushless Hub Motor | 48v 1200w Brushless Hub Motor Manufacturers - FENFA’s Appendix A as of the date of this reissuance. Effective immediately,OEM China N95 Respirator Mask Disposable Factory - Yangtuo - 169136,Wholesale Cheap OEM/ODM Power Bank 6000mah Suppliers & Manufacturers Quotes - YIMI,Mobile food trailer in Dubai | Mobile food trailer in Dubai Manufacturers - GANGTING DIANCHE. Further explanation of the revisions can be found in theOEM China Lotion Jars With Lids Manufacturers - Huijiong - 171260.
- Wholesale CE High Quality Refillable Bottle For Travel Products Cheap Price - Credible-OEM China Aluminum Cast Factory - 70694(OEM China Safety Suits OEM/ODM Quotes - Pantex - 173272, 2020)
- Wholesale China Aluminum Cylinder Heads Exporter - SAMUEL - 168906
- Wholesale CE High Quality Metal Table Products Cheap Price - Yezhi(Updated October 15, 2020)
- Wholesale Cheap OEM/ODM Gold Supplier Galvanized Wire Factory & Supplier Price - Huaxin(Updated October 15, 2020)
OEM China Digital Ir Thermometer Suppliers - Aj Union - 149916Appendix 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 OEM Custom Stainless Ball Valve Factory & Supplier Price - JKG Valve-Wholesale CE High Quality Spline Drive Shafts Factory & Supplier Price - Ningbo TSY Auto Technology Co Ltd.
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:Desktop Laser Cutting Machine For Sale | Desktop Laser Cutting Machine For Sale OEM/ODM - HANS YUEMING.
| 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 |
|
| China Supply Custom Glass Tube Candle Jar Products Cheap Price - Yanjia., Ltd. | YH/KN95-1 | |
| Supply China Plastic Cream Jar Wholesaler - Huijiong - 171260. | 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 | |
| Ptp Cnc Machining Center | Ptp Cnc Machining Center Manufacturers - Singhui CNC., Ltd. | 20182140615 Folded | |
| Wholesale China China Supplier Large Type Concrete Batching Plant OEM/ODM Quotes - Janeoo - 180854. 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 | |
| OEM China Custom Machined Parts Factory - 102350., 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 | |
| Laser Fabric Cutting Machine Price | Laser Fabric Cutting Machine Price Price - HANS YUEMING, 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 | |
| Cnc Angle Drilling Machine | Cnc Angle Drilling Machine Suppliers - QUICK-FULLTEK., LTD. | PM-P2 | |
| SPRO Medical Products (Wholesale CE High Quality Vibratory Road Roller Products Cheap Price - Grandway) 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 | |
| Metal Nonmetal Laser Cutting Machine | Metal Nonmetal Laser Cutting Machine Factory - Ruijie. | 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 | |
| Manukau WaitakereDownpipes NZ New Zealand - GMZ Roofing., Ltd | DHA01 | |
| ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
| Supply China Ceiling Tee Bar Manufacturers - Beihua - 165421., 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 China Customized Cast Steel Manufacturers - Neuland Metals - 161517., 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 | |
| Wood Furniture Design Machine | Wood Furniture Design Machine Suppliers - QUICK-FULLTEK., Ltd. | YBD-2 | |
| China Supply Custom Sport Shorts Suppliers & Manufacturers Quotes - Fullerton., LTD. | LY9501 | |
| Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
| Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
| Supply OEM Custom Yoke Joint Products Cheap Price - JianXin., Ltd. | XPM2121 | |
| Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
| Supply OEM Custom Threaded Y-Strainer Products Cheap Price - JKG Valve., Ltd. | GY2020001 | |
| Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
| ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
| Wholesale China China Supplier Classical Concrete Batching Plant Suppliers - Janeoo - 180854., Ltd. | AKF6002 | |
| ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
| Silkprint Boxes | Silkprint Boxes Factory - Essia(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 | |
| Supply China Surgical Mask Art Exporter - YOAU - 182586., Ltd. | HT9510V, HT9510 | |
| Quanzhou Caier Paper Co., Ltd. | CC001 | |
| Shandong C.I.R.S. Garments Co., Ltd. | LSD008 | |
| Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | |
| OEM China Solar Tracker Pier I Beam OEM/ODM Quotes - Rainbow - 153339(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 | |
| Decorative Aluminum Sheet Panels | Decorative Aluminum Sheet Panels OEM/ODM - Jingwan., 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 Low Rpm Dc Motor Wholesaler - Twirl - 157613., 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 | |
| Cnc Router Drilling Machine | Cnc Router Drilling Machine Factory - Singhui CNC., Ltd | HB202001-WH, HN202001 | |
| OEM China 12v Electric Motor With Gearbox Manufacturers - Twirl - 157613., Ltd. | Y195 | |
| Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
| ZK-BEST (Wholesale CE High Quality Vibratory Road Roller Products Cheap Price - Grandway) 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 | |
| Cylinder Components | Cylinder Components Factory - YX-Hydraulic. 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 Small Volume Perfume Glass Bottle Products Cheap Price - Credible., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
|
OEM China Precision Cast Parts Supplier Wholesaler - Neuland Metals - 161517(Wholesale China Cnc Engraver For Wood Exporter - JCUT - 168578)
Wholesale Cheap OEM/ODM Silicone Cupping Cup Products Cheap Price - CredibleWholesale China Pure Silicone Round D Perforated Drainage Tube Suppliers - Richeng - 168663. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Led Workplace Lighting | Led Workplace Lighting Manufacturers - Abest'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,Small Hydraulic Ram | Small Hydraulic Ram Price - YX-Hydraulic.China Supply Custom Strip Light Factory & Supplier Price - Lowcled, 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:OEM China Amber Foamer Bottles Factory - Huijiong - 171260
| OEM China Combination Clothing Wholesaler - Pantex - 173272 | Manufacturer | Respirator Model(s)Wholesale China Aluminum Cylinder Heads Exporter - SAMUEL - 168906 |
|---|---|---|
| 2020-10-26 | AAB (China) Co., Ltd | KN95 |
| 2020-10-26 | Wholesale China China Supplier Classical Concrete Batching Plant Suppliers - Janeoo - 180854., 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 Silicone Malecot Catheter Exporter - Richeng - 168663., 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 | Wholesale CE High Quality Bar Stool Products Cheap Price - Yezhi., 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 | 1000w Laser Cutter | 1000w Laser Cutter Suppliers - Ruijie., 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 | Supply OEM Custom Sheet Metal Fabricators Suppliers & Manufacturers Quotes - JianXin., Ltd. | Bocai KN95 |
| 2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
| 2020-10-26 | 626z Bearing | 626z Bearing Manufacturers - Hxh. 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 |
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- Supply China Disposable Black Surgical Mask Suppliers - YOAU - 182586(Updated October 20, 2020)
China Supply Custom Glass Amber Jar Factory & Supplier Price - YanjiaExhibit 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-Printed Circuit Board | Printed Circuit Board Factory - Golden Triangle Group | 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 |
Fancy-Plywood-Mdf-Block BoardFace 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)OEM China Disposable Face Mask Wholesaler - Liao Cheng - 172990(see section 564(g)(2)(B)). Under section 564(c) of the Act,Wholesale China Acoustic Mineral Fiber Ceiling Tiles Wholesaler - Beihua - 165421“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,OEM China Alcohol Hand Sanitizer Gel Pocket Wholesaler - Aj Union - 149916(see section 564(g)(2)(C) of the Act),5rpm Bbq Gear Motor | 5rpm Bbq Gear Motor Manufacturers - FENFA.
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