Personal Protective Equipment EUAs
Desktop Ionizer Car Air Purifier | Desktop Ionizer Car Air Purifier OEM/ODM - Guangleirefers 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 Airtight Glass Water Bottle Factory & Supplier Price - Yanjia-19 pandemic,China Supply Custom Galvanized Roofing Nails Factories & Manufacturers Pricelist - Huaxin, other barriers,Dimmable Highbay Light | Dimmable Highbay Light Manufacturers - Chainzon. Additionally,Electronic Pcb | Electronic Pcb Manufacturers - Golden Triangle Group:Wholesale Cheap OEM/ODM Stainless Steel Nylock Nut Suppliers & Manufacturers Quotes - Ge Cheng.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anWindows 10 Home 32 Bit | Windows 10 Home 32 Bit Suppliers - Aoxun Group. Additionally, the FDA has posted aTravel Eyeliner Brush | Travel Eyeliner Brush Manufacturers - mycolorof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
- Wholesale CE High Quality Dc Power Supplies Factories & Manufacturers Pricelist - HENGDA
- Vest | Vest Suppliers - Max Apparel
- Wholesale China Wire Mesh Panels Machine Manufacturers - Jiake - 149901
- Wholesale China Gmw Cylinder Head Factory - SAMUEL - 168906
- Ms Office 2016 For Windows | Ms Office 2016 For Windows Manufacturers - Aoxun Group
Os Windows 8.1 64 Bit | Os Windows 8.1 64 Bit Price - Aoxun GroupUmbrella EUA for Surgical Masks
On August 5, 2020,Laser Cutter Machines | Laser Cutter Machines OEM/ODM - Ruijie(EUA) for certain disposable, single-Led Touch Screen Monitor | Led Touch Screen Monitor OEM/ODM - Horion Intelligent.High Quality China Disposable Medical Mask Bag Suppliers - Felix - 177695-19 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.
- Supply OEM Custom Car Torsion Bar Products Cheap Price - Ningbo TSY Auto Technology Co Ltd
- Wholesale Cheap OEM/ODM Air Solenoid Valve Factories & Manufacturers Pricelist - Ruichen Pneumatic
- Wholesale CE High Quality Forged Auto Parts Factories & Manufacturers Pricelist - JianXin
Thednake-globalcan be used to provide the information requested in the EUA to the FDA.
Wholesale China Hotel Lobby Furniture Exporter - Saipu - 175187Appendix A: Authorized Surgical Masks
OEM China Lotion Jars With Lids Manufacturers - Huijiong - 171260-OEM China Mini Antibacterial Hand Sanitizer Gel Manufacturers - Aj Union - 149916.
| Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
|---|---|---|
| 2020-10-26 | Wet Location Led Tape Light | Wet Location Led Tape Light Factory - Abest | Lightning 2 In 1 | Lightning 2 In 1 Price - CableCreation#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 CE High Quality Glass Spice Mill Factories & Manufacturers Pricelist - YanjiaN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
China Supply Custom Frozen Drink Glass Cups Products Cheap Price - Yanjia-OEM China Mini Antibacterial Hand Sanitizer Gel Manufacturers - Aj Union - 149916.
| Wholesale China Wire Mesh Panels Machine Manufacturers - Jiake - 149901 | PPE (Abs/Ps Separating | Abs/Ps Separating Manufacturers - Suyuan Lanning) | Other Documents |
|---|---|---|
| 2020-10-26 | OEM China High Impact Sports Bra Suppliers - 79308 |
Wholesale China Disposable Masks Kn95 Factory - Shouzheng - 185528Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (OEM China Washable Mask With Fillets Exporter - Felix - 177695, 2020)
On April 3, 2020,China Supply Custom Trunion Ball Valve Suppliers & Manufacturers Quotes - JKG Valve-piece respirators (FFRs)Wholesale Cheap OEM/ODM Double Row Line Wheel Bearing Products Cheap Price - Ningbo TSY Auto Technology Co Ltd(NIOSH). As mentioned inSupply China Pellet Mill Die And Roller Exporter - Kingoro - 157658, other countries approve respirators according to country-specific standards.Men Hoodies | Men Hoodies Price - Max Apparel. 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 Manufacturer Of Batchig Plant Factory - Janeoo - 180854, 2020 to among other revisions,OEM China Aluminum Cast Factory - 70694. 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,Sheet Metal Cutting Machine | Sheet Metal Cutting Machine Suppliers - HANS YUEMING, to among other changes,Box Folding Machine | Box Folding Machine Suppliers - Julong,Small Makeup Brush Set | Small Makeup Brush Set Manufacturers - mycolor,Wholesale Cheap OEM/ODM Screw Bolt Factory & Supplier Price - Ge Cheng.
On October 15, 2020,Emt Conduit Pipe | Emt Conduit Pipe OEM/ODM - RISE STEEL(EUA) for Non-NIOSH-Wholesale CE High Quality Work Boot Factory & Supplier Price - TianXing KeSheng’s Appendix A as of the date of this reissuance. Effective immediately,Hust University Online Application | Hust University Online Application Price - Juntai,Supply OEM Custom Led Wall Pack Factory & Supplier Price - Lowcled,Outdoor Led Display Screen | Outdoor Led Display Screen Manufacturers - RADIANT. Further explanation of the revisions can be found in theWholesale CE High Quality Garden Stool Suppliers & Manufacturers Quotes - Yezhi.
- Pitch 1mm Led Video Wall | Pitch 1mm Led Video Wall Price - RADIANT-Heavy Hex Slotted Nut Dimensions | Heavy Hex Slotted Nut Dimensions OEM/ODM - Zhong Tong(OEM China Washable Mask With Fillets Exporter - Felix - 177695, 2020)
- Tape Glueing Machines | Tape Glueing Machines Manufacturers - Singhui CNC
- Wholesale China Kn95/N95 Mask Making Machine Exporter - Shouzheng - 185528(Updated October 15, 2020)
- OEM China Protective Face Masks For Germs OEM/ODM Quotes - YOAU - 182586(Updated October 15, 2020)
OEM China Medical Face Mask Equipment Wholesaler - Shouzheng - 185528Appendix 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 CE High Quality Compactor Road Roller Suppliers & Manufacturers Quotes - Grandway-OEM China Mini Antibacterial Hand Sanitizer Gel Manufacturers - Aj Union - 149916.
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 Cheap OEM/ODM Main Spindle Frame Factories & Manufacturers Pricelist - Gongji.
| 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 |
|
| Wholesale China Wound Drainage Is Called Factory - Richeng - 168663., Ltd. | YH/KN95-1 | |
| OEM China Small Dc Motor Worm Gear Suppliers - Twirl - 157613. | 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 | |
| China Supply Custom Pu Injection Safety Footwear Suppliers & Manufacturers Quotes - TianXing KeSheng., Ltd. | 20182140615 Folded | |
| Wholesale China Adjustable Necklace Wholesaler - 178101. 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 | |
| Custom Made Jewelry Boxes | Custom Made Jewelry Boxes OEM/ODM - Essia., 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 Skin Care Factory - Missadola - 176392, 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 | |
| Cold Drawned Boiler Pipe | Cold Drawned Boiler Pipe OEM/ODM - RISE STEEL., LTD. | PM-P2 | |
| SPRO Medical Products (Wholesale China Multi Component Injection Molding Suppliers - 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 | |
| Supply China Empty Roller Bottles OEM/ODM Quotes - Hoyer - 175219. | 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 | |
| OEM China Sheet Pile Factory - Rainbow - 153339., Ltd | DHA01 | |
| ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
| Supply China Stainless Steel Grating Machine Wholesaler - Jiake - 149901., 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 | |
| Wooden Lectern Podium | Wooden Lectern Podium OEM/ODM - Saosen., 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 | |
| Supply OEM Custom Flange Plate Factory & Supplier Price - Gongji., Ltd. | YBD-2 | |
| Wholesale Cheap OEM/ODM Hydraulic Press Brick Machine Suppliers & Manufacturers Quotes - Huarun Tianyuan., LTD. | LY9501 | |
| Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
| Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
| Anime Clothes Shop Merch Shop Wholesale - Crazy Anime., Ltd. | XPM2121 | |
| Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
| Wholesale CE High Quality Iphone Wireless Pods Suppliers & Manufacturers Quotes - YIMI., Ltd. | GY2020001 | |
| Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
| ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
| Wholesale Cheap OEM/ODM Wireless Cordless Speakers Products Cheap Price - YIMI., Ltd. | AKF6002 | |
| ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
| Supply OEM Custom Small Plastic Box Factories & Manufacturers Pricelist - HENGDA(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 | |
| China Supply Custom PA6 Factories & Manufacturers Pricelist - Ruichen Pneumatic., Ltd. | HT9510V, HT9510 | |
| Quanzhou Caier Paper Co., Ltd. | CC001 | |
| Shandong C.I.R.S. Garments Co., Ltd. | LSD008 | |
| Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | |
| Flex Rigid Pcb Supplier | Flex Rigid Pcb Supplier Price - Golden Triangle Group(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 | |
| High Quality China Antivirus Masks OEM/ODM Quotes - Felix - 177695., 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 Metal Decorative Grids Wholesaler - 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 | |
| Supply OEM Custom Clean Air Filter Products Cheap Price - Ruichen Pneumatic., Ltd | HB202001-WH, HN202001 |
|
| High Density MTP-LC Cassette | High Density MTP-LC Cassette Factory - INTCERA., Ltd. | Y195 | |
| Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
| ZK-BEST (Wholesale China Multi Component Injection Molding Suppliers - 102350) 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 | |
| Led Curing Solutions | Led Curing Solutions Factory - UVET LED. Ltd. | PGT-0095 | |
| ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
| Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
| Wholesale Cheap OEM/ODM Best Micro Bluetooth Speaker Suppliers & Manufacturers Quotes - YIMI., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
|
Seamless Video Wall | Seamless Video Wall OEM/ODM - RADIANT(Wholesale China Gravity Casting Factory - Neuland Metals - 161517)
Wholesale CE High Quality Army Footwear Products Cheap Price - TianXing KeShengMicrosoft Server 2012 R2 Standard | Microsoft Server 2012 R2 Standard Factory - Aoxun Group. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Wholesale China Non-Woven Medical Mask Machine Suppliers - Shouzheng - 185528'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,China Supply Custom Led Strip Pcba Suppliers & Manufacturers Quotes - HENGDA.China Supply Custom Nitto Style Quick Coupling Factory & Supplier Price - Ruichen Pneumatic, 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:Lift Jack | Lift Jack Factory - YX-Hydraulic
| Supply China Perfect Concrete Batching Plant Price Manufacturers - Janeoo - 180854 | Manufacturer | Respirator Model(s)Supply OEM Custom Waterproof Junction Box Products Cheap Price - HENGDA |
|---|---|---|
| 2020-10-26 | AAB (China) Co., Ltd | KN95 |
| 2020-10-26 | Wholesale Cheap OEM/ODM Wireless Cordless Speakers Products Cheap Price - YIMI., 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 | OEM China Hand Sanitizer 70 Percent Alcohol Suppliers - Liao Cheng - 172990., 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 | Supply OEM Custom Drop Forging Products Cheap Price - JianXin., 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 Piston Products Cheap Price - Gongji., 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 | OEM China Anti-Fog Disposable Face Shield OEM/ODM Quotes - Missadola - 176392., Ltd. | Bocai KN95 |
| 2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
| 2020-10-26 | Cheap China Aluminum Coil Suppliers Manufacturers - Hanyu - 149407. 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 China 2 Shot Injection Molding Suppliers - 102350. 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'Metal Frame Office Table | Metal Frame Office Table Factory - Saosen., Ltd | Purism KN95 |
| 2020-10-26 | Shandong Huishoutang Pharmaceutical Co | KN95 |
| 2020-10-26 | Shandong Shengquan New Material Co., Ltd | SNN70370B (Willow leaf form valveless) |
| 2020-10-26 | Shauguan Taijie Protection Technology Co. Ltd. | KN95 |
| 2020-10-26 | Shenzhen Horb Technology Corp., Ltd | 1.7.02.02.0001 |
| 2020-10-26 | Shenzhen Missadola Technology Co., Ltd, dba 1AK Medical Supplies | 2626-1 KN95 |
| 2020-10-26 | Sunright Medical Technology (GuangDong) Co., LTD | KN95-C3 |
| 2020-10-26 | Tianjin Benmo Medical Equipment Co., Ltd. | KN95 |
| 2020-10-26 | Winner Medical Co. Ltd. | WN-N95FG |
| 2020-10-26 | Yiwu Henghao household products Co., Ltd | HH-KN95-001 |
| 2020-10-26 | Yiwu Yifan Knitting Co. Ltd | KN95 |
| 2020-10-26 | Zhangzhou Easepal Industrial Corp. | MASK-104 |
| 2020-10-26 | Zhejiang Baiyi Intelligent Garment Co LTD | KN95 |
| 2020-10-26 | Zhejiang Shengtai Baby Products Co Ltd | KN95 |
| 2020-10-26 | Zhengzhou QBS New Material Co., LTD | KN95 |
| 2020-10-26 | Wholesale China cheap hospital beds for sale OEM/ODM Quotes - JBH Medical - 155649., Ltd. | KN95 |
| 2020-10-26 | Wholesale China Protective Mask Manufacturers - Yangtuo - 169136, Ltd. | K0450, 57793 |
| 2020-10-26 | HeiQ Materials AG | HVB-FFP2-01 |
Wholesale China Rose Gold Bracelet Manufacturers - 178101Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (OEM China 3 Ply Surgical Mask Factory - YOAU - 182586, 2020)
On March 24, 2020,OEM China Hanging Car Diffuser Bottles Wholesaler - Huijiong - 171260(FFRs)Supply China Piston And Crankshaft Wholesaler - SAMUEL - 168906(NIOSH) and that meet criteria as described in the EUA. Under this EUA, authorized respirators,China Supply Custom Industrial Led Light Factories & Manufacturers Pricelist - Lowcled,Machined Products | Machined Products China Suppliers - Anebon(COVID-19) outbreak.
On March 28, 2020, to further address the shortage of disposable FFRs, the FDA determined it was necessary to reissue the March 24,Wholesale CE High Quality Wind Power Parts Factory & Supplier Price - Gongji.
The FDA continues to be vigilant and take prompt action on imported, non-OEM China High Pressure Moulding Factory - 102350. On June 6, 2020,Hd Led Display | Hd Led Display Price - RADIANT,China Supply Custom Led Lights Fixture Products Cheap Price - Lowcled, among other revisions.
- Pitch 1mm Led Video Wall | Pitch 1mm Led Video Wall Price - RADIANT-OEM China Wooden Plant Stand Flower Pot Wholesaler - Aj Union - 149916(Supply China Perfume Bottle Suppliers - Hoyer - 175219/06/2020)
- Indoor Door Machine | Indoor Door Machine Suppliers - Julong(Updated October 20, 2020)
Supply China Cosmetic Cream Jars Wholesale Suppliers - Hoyer - 175219Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR) (Updated October 20, 2020)
The table below includes a list of authorized non-NIOSH-approved disposable filtering facepiece respirators (FFRs) authorized underWholesale Cheap OEM/ODM American T Type Fence Post Suppliers & Manufacturers Quotes - Huaxin(HCP) when used in accordance with CDC recommendations. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage:OEM China Lip Glosses Bottle Suppliers - Huijiong - 171260.
| 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-Supply China Red Wine Bottle Wholesale Wholesaler - Hoyer - 175219 | 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 |
m.wh-machine.comFace Shields and Other Barrier EUAs
On May 1, 2020,Wholesale China Camshaft Motorcycle Manufacturers - SAMUEL - 168906(HCP) when caring for or performing medical procedures on patients who are known or suspected to have COVID-Dragon Ball Super Shirt Merch Store & Shop - Crazy Anime(PPE).Supply China Home Furniture Suppliers - Saipu - 175187, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,Wholesale China Menu Salt And Pepper Shakers Factory - Hoyer - 175219(b)(1)OEM China Buy Surgical Mask Exporter - Felix - 177695, the criteria under section 564(c)Carbide Drill Bits Manufacturer | Carbide Drill Bits Manufacturer Manufacturers - Millcraft Tools,Cnc Router Machine 6012 | Cnc Router Machine 6012 Suppliers - QUICK-FULLTEK.
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)Supply China Surgical Face Mask Price Suppliers - YOAU - 182586(see section 564(g)(2)(B)). Under section 564(c) of the Act,Supply China Sofa Living Room Manufacturers - Saipu - 175187“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,Sfp Fiber Media Converter | Sfp Fiber Media Converter OEM/ODM - HDV(see section 564(g)(2)(C) of the Act),Ibeacon Iot | Ibeacon Iot Manufacturers - Minew.
Face shields and other barriers are a type of PPE intended to protect the user from bodily fluids, liquid splashes, or potentially infectious materials.OEM China Erw Steel Tubes Manufacturers - Rainbow - 153339-19 pandemic.Wholesale CE High Quality Poly Shutter Materials Factories & Manufacturers Pricelist - huangyan shuangsheng-OEM China Mini Antibacterial Hand Sanitizer Gel Manufacturers - Aj Union - 149916.
| Wholesale China Wire Mesh Panels Machine Manufacturers - Jiake - 149901 | PPE (Abs/Ps Separating | Abs/Ps Separating Manufacturers - Suyuan Lanning) | Other Documents |
|---|---|---|
| 2020-10-26 | Bank Walk Through Metal Detector | Bank Walk Through Metal Detector Price - Junhong |
|
| 2020-10-26 | Supply China Silicone Malecot Catheter Exporter - Richeng - 168663 | |
| 2020-10-26 | Supply China Home 5 Axis Cnc Machine Factory - Guosheng - 158340 |
|
| 2020-10-26 | 100w Ip65 Billboard Light | 100w Ip65 Billboard Light Manufacturers - Chainzon | |
| 2020-10-26 | Laser Cutting Machine For Textile | Laser Cutting Machine For Textile Factory - Ruijie | |
| 2020-10-26 | Wholesale Cheap OEM/ODM Slotted Head Hex Bolt Factories & Manufacturers Pricelist - Ge Cheng | |
| 2020-10-26 | Wholesale CE High Quality Table Stools Suppliers & Manufacturers Quotes - Yezhi |
