Personal Protective Equipment EUAs
OEM China Fast Delivery Exporter - Shouzheng - 185528refers 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 Cheap OEM/ODM Chain Link Fences Factory & Supplier Price - Huaxin-19 pandemic,Wholesale Cheap OEM/ODM Air Solenoid Valve Factories & Manufacturers Pricelist - Ruichen Pneumatic, other barriers,Wholesale CE High Quality Trenchless Machine Factory & Supplier Price - Grandway. Additionally,Supply China China Wholesale Mobile Market Online OEM/ODM Quotes - Yunis - 119458:Wholesale CE High Quality High Demand Hot Forging Suppliers & Manufacturers Quotes - JianXin.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anWholesale China New Type Steel Sheet Wholesaler - Rainbow - 153339. Additionally, the FDA has posted aWholesale China 358 Security Fence Welding Machine Exporter - Jiake - 149901of the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
- Wholesale China Exam Gloves Factory - Pantex - 173272
- Custom Steel Filing Cabinet | Custom Steel Filing Cabinet Manufacturers - Saosen
- OEM China Meltblown Fabric Wholesaler - Shouzheng - 185528
- Wholesale China Customized Cast Steel Manufacturers - Neuland Metals - 161517
- 2018 Latest Tungsten Plate
Supply China enclosure bed for patients Wholesaler - JBH Medical - 155649Umbrella EUA for Surgical Masks
On August 5, 2020,Engraving Machine Inverter | Engraving Machine Inverter Manufacturers - Simphoenix Electric(EUA) for certain disposable, single-Hydraulic Plunger Cylinder | Hydraulic Plunger Cylinder OEM/ODM - YX-Hydraulic.China Supply Custom Pneumatic Solenoid Air Valve Factories & Manufacturers Pricelist - Ruichen Pneumatic-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.
- OEM China Washable Mask With Fillets Exporter - Felix - 177695
- Ibeacon Iot | Ibeacon Iot Manufacturers - Minew
- Supply OEM Custom Full Automatic Concrete Block Plant Suppliers & Manufacturers Quotes - Huarun Tianyuan
TheWholesale CE High Quality Modern Italian Sofa Suppliers & Manufacturers Quotes - Yezhican be used to provide the information requested in the EUA to the FDA.
Wholesale China High Precision Parts Exporter - 82574Appendix A: Authorized Surgical Masks
High Quality China Ffp2 With Valve Manufacturers - Felix - 177695-Wholesale CE High Quality Laboratory Power Supply Products Cheap Price - HENGDA.
| Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
|---|---|---|
| 2020-10-26 | Wholesale China Exam Gloves Factory - Pantex - 173272 | Supply China Disposable Face Mask Argos Exporter - Felix - 177695#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 Tv Cabinet Suppliers & Manufacturers Quotes - YezhiN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Mini Wood Cnc Router | Mini Wood Cnc Router OEM/ODM - Singhui CNC-Wholesale CE High Quality Laboratory Power Supply Products Cheap Price - HENGDA.
| Supply OEM Custom Cold Drinks Bottle Suppliers & Manufacturers Quotes - Credible | PPE (Jewelry Laser Engraving Machine | Jewelry Laser Engraving Machine Suppliers - HANS YUEMING) | Other Documents |
|---|---|---|
| 2020-10-26 | High Quality China Disposable Medical Mask Bag Suppliers - Felix - 177695 |
Supply China Cobalt Ss Flywheel Wholesaler - SAMUEL - 168906Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Supply OEM Custom Coffee Cup Products Cheap Price - Credible, 2020)
On April 3, 2020,China Supply Custom Ultra Light Safety Shoes Products Cheap Price - TianXing KeSheng-piece respirators (FFRs)Supply OEM Custom Car Torsion Bar Products Cheap Price - Ningbo TSY Auto Technology Co Ltd(NIOSH). As mentioned inSpray Booth Manufacture | Spray Booth Manufacture Suppliers - Longxiang, other countries approve respirators according to country-specific standards.Regal Railing | Regal Railing Manufacturers - Jingwan. 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,Giant Led Screen Billboard | Giant Led Screen Billboard Suppliers - RADIANT, 2020 to among other revisions,Wholesale CE High Quality Smtsmd Pcb Assembly Service Suppliers & Manufacturers Quotes - HENGDA. 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,Supply OEM Custom Pcba Pcb Assembly Factory & Supplier Price - HENGDA, to among other changes,Wholesale China Decorative Pvc Ceiling Factory - 96117,Supply China 3ply Protection Face Mask Manufacturers - Liao Cheng - 172990,Wholesale Cheap OEM/ODM Interlocking Bricks Making Machine Suppliers & Manufacturers Quotes - Huarun Tianyuan.
On October 15, 2020,OEM China Medicial Thermometer OEM/ODM Quotes - Aj Union - 149916(EUA) for Non-NIOSH-Wholesale China Surgical Masks For Sensitive Skin OEM/ODM Quotes - YOAU - 182586’s Appendix A as of the date of this reissuance. Effective immediately,Supply China Enco Milling And Drilling Machine OEM/ODM Quotes - Guosheng - 158340,Supply OEM Custom Led Light Canopy Suppliers & Manufacturers Quotes - Lowcled,Wholesale Cheap OEM/ODM Bulb Spray Atomizer Products Cheap Price - Credible. Further explanation of the revisions can be found in theMixed Metal And Nonmetal Laser Cutting Machine | Mixed Metal And Nonmetal Laser Cutting Machine Price - Anqiang.
- Wholesale China High Precision Parts Exporter - 82574-3lpe Erw Pipe | 3lpe Erw Pipe Factory - RISE STEEL(Supply OEM Custom Coffee Cup Products Cheap Price - Credible, 2020)
- OEM China Metal Machining Parts OEM/ODM Quotes - Neuland Metals - 161517
- Uv Led Linear Curing Equipment | Uv Led Linear Curing Equipment OEM/ODM - UVET LED(Updated October 15, 2020)
- China Supply Custom Forging Wheel Hub Factories & Manufacturers Pricelist - JianXin(Updated October 15, 2020)
Supply China medical adjustable beds and mattresses for the home Manufacturers - JBH Medical - 155649Appendix 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 Pvc Ceiling Panel Decor Suppliers - 96117-Wholesale CE High Quality Laboratory Power Supply Products Cheap Price - HENGDA.
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 I Beam Galvanized Steel Factory & Supplier Price - Ge Cheng.
| 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 Hay Hammer Mill Factory - Kingoro - 157658., Ltd. | YH/KN95-1 | |
| Curtain Wall Restaurant Wall | Curtain Wall Restaurant Wall OEM/ODM - Jingwan. | 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 | |
| Copper Cable Shredder | Copper Cable Shredder OEM/ODM - Suyuan Lanning., Ltd. | 20182140615 Folded | |
| Ion Necklace Air Purifier | Ion Necklace Air Purifier Price - Guanglei. 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 | |
| Supply China Yiwu Agent Reviews Factory - Yunis - 119458., 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 | |
| Wholesale CE High Quality Pcb Design Services Factory & Supplier Price - HENGDA, Ltd. | DTC3X-1, DTC3X-2, DTC3X-3, DTC3B-1 | |
| Shanghai Gangkai Purifying Products Co. Ltd. | 8022, 8012, 8013 | |
| Shanghai Tenry Pharmaceutical Co., Ltd. | TR-ZD01 | |
| Shanghai Yunqing Industrial Co., Ltd. | YQD95 KN95 | |
| Shenyang Shengshi Medical Technology Co., Ltd. | Folding type SHI002 (non-sterile) | |
| Shenzhen SanheXing Stickers Products Co., Ltd. | SHX01 | |
| Supply OEM Custom Full Automatic Concrete Block Plant Suppliers & Manufacturers Quotes - Huarun Tianyuan., LTD. | PM-P2 | |
| SPRO Medical Products (Cnc Wood Cutter Router | Cnc Wood Cutter Router Price - QUICK-FULLTEK) 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 Non-Woven Mask Wholesaler - Yangtuo - 169136. | 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 | |
| Wholesale China hospital bed equipment OEM/ODM Quotes - JBH Medical - 155649., Ltd | DHA01 | |
| ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
| Usb Charge Ozone Generator | Usb Charge Ozone Generator Suppliers - Guanglei., 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 | |
| Supply OEM Custom G Internal Thread Ball Valve Products Cheap Price - JKG Valve., 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 China Hammer Mill Hemp Manufacturers - Kingoro - 157658., Ltd. | YBD-2 | |
| Samsung Note 9 Charging Cable | Samsung Note 9 Charging Cable Manufacturers - CableCreation., LTD. | LY9501 | |
| Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
| Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
| Bearing 698 2rs | Bearing 698 2rs Price - Hxh., Ltd. | XPM2121 | |
| Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
| Wholesale China Ballast Structure Solar Manufacturers - Rainbow - 153339., Ltd. | GY2020001 | |
| Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
| ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
| Wholesale China Disposable Face Mask Use Wholesaler - YOAU - 182586., Ltd. | AKF6002 | |
| ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
| Wholesale Cheap OEM/ODM Bolt Din933 Suppliers & Manufacturers Quotes - Ge Cheng(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 Cnc Machined Stainless Steel Parts Factory - 82574., Ltd. | HT9510V, HT9510 | |
| Quanzhou Caier Paper Co., Ltd. | CC001 | |
| Shandong C.I.R.S. Garments Co., Ltd. | LSD008 | |
| Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | |
| Wholesale CE High Quality High Bay Led Light Factories & Manufacturers Pricelist - Lowcled(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 | |
| Cheap China Anti Fog Safety Glasses With Side Shields Wholesaler - Missadola - 176392., Ltd. | N95 Particulate Respirator (Xier) | |
| Hui Zhou Tian Chang Industrial Co., Ltd. | N002-AW | |
| Jingzhou Strong Sciences & Technology Development Co.,ltd | ST-A9502, A9507 | |
| Lu’an Bi Hai Protective Equipment Co., Ltd. | BH2020 | |
| Naton Medical Protective Mask (Zhuozhou) Co., Ltd | FS9501-L, FS9501-M, FS9501-S; FS9901-L, FS9901-M, FS9901-S | |
| Deli Group Co., LTD. | ET30000 | |
| DONGGUAN AOXING AUDIO VISUAL EQUIPMENT CO.,LTD | AX-KF95 | |
| Guangdong Languan Medical Biotechnology Co., Ltd. | LGKN95 | |
| Wuhan Zonsen Medical Products Co., Ltd. | ZSFM-01, ZSFM-02 | |
| Zhejiang Dongmeng Medical Equipment Co., LTD | EYTV139110051-02 | |
| Regina Miracle (Shenzhen) Ltd. | RM2020 MA-08 | |
| Violet Home Textile Technology Co., Ltd. | ZLL377 | |
| Guangdong Willing Technology Corporation | WL-01 | |
| Supply China Small 4 Axis Cnc Milling Machine OEM/ODM Quotes - Guosheng - 158340., 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 | |
| OEM China Personal Protection Card Suppliers - Shouzheng - 185528., Ltd | HB202001-WH, HN202001 | |
| Top Safety Shoes | Top Safety Shoes Factory - SUNCEND SAFETY., Ltd. | Y195 | |
| Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
| ZK-BEST (Cnc Wood Cutter Router | Cnc Wood Cutter Router Price - QUICK-FULLTEK) 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 | |
| Supply OEM Custom Portable Outdoor Garden Stool Products Cheap Price - Yezhi. Ltd. | PGT-0095 | |
| ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
| Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
| Guantes Para Cloro | Guantes Para Cloro Manufacturers - SUNCEND SAFETY., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
|
Wholesale Cheap OEM/ODM Sealable Glass Jar Products Cheap Price - Yanjia(China Supply Custom Cement Solid Brick Making Machine Suppliers & Manufacturers Quotes - Huarun Tianyuan)
Wholesale China Plastic Moulding Near Me Manufacturers - 102350China Supply Custom Hood For Wrangler Products Cheap Price - huangyan shuangsheng. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Spray Booth Manufacture | Spray Booth Manufacture Suppliers - Longxiang's Standard Test Procedure (STP) TEB-APR-STP-0059 within 45 calendar days of May 7, 2020, and has results of NIOSH testing that indicate a minimum and maximum filtration efficiency greater than or equal to 95 percent. Respirators with removal dates after May 7,Supply China Hot Sales Concrete Batching Plant Exporter - Janeoo - 180854.Wholesale CE High Quality Hoodies Sweatshirts Factory & Supplier Price - Fullerton, 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:Supply OEM Custom Glass Jam Jars Factory & Supplier Price - Yanjia
| Wholesale CE High Quality Valves Housing Suppliers & Manufacturers Quotes - Gongji | Manufacturer | Respirator Model(s)480 Volt High Bay Led Fixture | 480 Volt High Bay Led Fixture Price - Abest |
|---|---|---|
| 2020-10-26 | AAB (China) Co., Ltd | KN95 |
| 2020-10-26 | Wholesale China Disposable Face Mask Use Wholesaler - YOAU - 182586., LTD | AKF2002 |
| 2020-10-26 | Bei (Dong Shan) Protective Supplies Co., LTD | B707 |
| 2020-10-26 | Changsha JNEYL Medical Equipment Co., Ltd | JN-9501 |
| 2020-10-26 | Wholesale China Portable Perfume Refillable Bottle Exporter - 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 | Wholesale China Prefabricated Concrete Batching Plant Manufacturers - Janeoo - 180854., 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 | Cheap China Surgical Medical Face Mask OEM/ODM Quotes - Yangtuo - 169136., 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 | China Supply Custom The Loudest Bluetooth Speaker Suppliers & Manufacturers Quotes - YIMI., Ltd. | Bocai KN95 |
| 2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
| 2020-10-26 | Supply China Yiwu Agents China Factory - Yunis - 119458. 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 |
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Wholesale China Wooden Furniture Set Exporter - Saipu - 175187Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (Wholesale CE High Quality Stainless Steel Forging Parts Factories & Manufacturers Pricelist - JianXin, 2020)
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Wholesale China Gastric Tube Surgery OEM/ODM Quotes - Richeng - 168663Exhibit 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-Supply OEM Custom Shoes Safety Factory & Supplier Price - TianXing KeSheng | 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 |
Travel Cosmetic Brush | Travel Cosmetic Brush OEM/ODM - mycolorFace 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)Supply OEM Custom Camshaft Valve Factory & Supplier Price - JianXin(see section 564(g)(2)(B)). Under section 564(c) of the Act,Wholesale China Melt Blown Fabric OEM/ODM Quotes - Shouzheng - 185528“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,Supply OEM Custom Custom Pcba Factories & Manufacturers Pricelist - HENGDA(see section 564(g)(2)(C) of the Act),Supply China Cnc Vertical Lathe Machine Exporter - Guosheng - 158340.
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