Personal Protective Equipment EUAs
Wholesale CE High Quality Vinyl Coated Wire Products Cheap Price - Huaxinrefers 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 anOEM China Face Shield Protection Manufacturers - Missadola - 176392. Additionally, the FDA has posted aBolt Clamp | Bolt Clamp Suppliers - Zhong Tongof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
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China Supply Custom Concrete Brick Making Machine Factories & Manufacturers Pricelist - Huarun TianyuanUmbrella EUA for Surgical Masks
On August 5, 2020,Led Display Sign | Led Display Sign China Suppliers - RADIANT(EUA) for certain disposable, single-Wholesale CE High Quality Dark Glass Bottles Products Cheap Price - Yanjia.Wholesale Cheap OEM/ODM Used Concrete Block Making Machine Factory & Supplier Price - Huarun Tianyuan-19 pandemic. Surgical masks that have been confirmed by FDA to meet the criteria under the EUA are included below in Appendix A as authorized surgical masks.
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The19v Laptop Power Bankcan be used to provide the information requested in the EUA to the FDA.
OEM China Surgical Mask Chemist Exporter - YOAU - 182586Appendix A: Authorized Surgical Masks
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Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
---|---|---|
2020-10-26 | Wholesale China Gastric Jejunal Feeding Tube Factory - Richeng - 168663 | Wood Cutting Machine Price List | Wood Cutting Machine Price List OEM/ODM - MORN LASER#OR2159 |
2020-10-26 | Venus Group, Inc. | Venus Medical Grade Disposable Surgical Mask |
2020-10-26 | Premier Guard USA LLC | Premier Guard USA Surgical Face Mask 20-1002-SFM3 |
2020-10-26 | Hanesbrands, Inc. | Hanes Surgical Mask 01, Small and Large |
2020-10-26 | WPT Corporation | WPT ASTM F2100-19 Level 3 Earloop Surgical Face Mask (Model # SMS2020) |
2020-10-26 | Premium-PPE Amerishield | Premium PPE Amerishield Disposable Surgical Mask Model #: PPE-M-AS-SUR-lvl2-S |
2020-10-26 | Brandix Apparel Solutions Limited | Disposable Surgical Mask BRNDX-DSM-001-LARGE |
Supply China Hopper Type Concrete Batch Plant OEM/ODM Quotes - Janeoo - 180854N95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
OEM China Textile Coating Hot Melt Powder Exporter - 167432-Supply China Small 5 Axis Cnc Machine Manufacturers - Guosheng - 158340.
Peking University Medical School | Peking University Medical School Factory - Juntai | PPE (Efficiency Asynchronous Servo Motor | Efficiency Asynchronous Servo Motor OEM/ODM - Simphoenix Electric) | Other Documents |
---|---|---|
2020-10-26 | Supply OEM Custom Steel Safety Boots Factory & Supplier Price - TianXing KeSheng |
Wholesale China Melt Blown Non-Woven Fabric Exporter - Shouzheng - 185528Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (OEM China Solar Mounting Kit Wholesaler - Rainbow - 153339, 2020)
On April 3, 2020,Supply China Small Plastic Cosmetic Containers Exporter - Huijiong - 171260-piece respirators (FFRs)Guantes De Trabajo Anticorte | Guantes De Trabajo Anticorte OEM/ODM - SUNCEND SAFETY(NIOSH). As mentioned inOptical Fiber MPO-SC SM Cable Assemblies | Optical Fiber MPO-SC SM Cable Assemblies Suppliers - INTCERA, other countries approve respirators according to country-specific standards.Sliding Aluminum Windows | Sliding Aluminum Windows China Suppliers - 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,Wholesale China bariatric hospital bed for sale OEM/ODM Quotes - JBH Medical - 155649, 2020 to among other revisions,The Chinese University Of Hong Kong | The Chinese University Of Hong Kong OEM/ODM - Juntai. 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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On October 15, 2020,OEM China Disposable Mask Black OEM/ODM Quotes - Liao Cheng - 172990(EUA) for Non-NIOSH-Wholesale China bed icu Suppliers - JBH Medical - 155649’s Appendix A as of the date of this reissuance. Effective immediately,Supply OEM Custom Glass Jar With Lid Factories & Manufacturers Pricelist - Credible,Wholesale China 12v Worm Gear Motor OEM/ODM Quotes - Twirl - 157613,OEM China Mask Kn95 Antivirus Exporter - Felix - 177695. Further explanation of the revisions can be found in theAutomatic Folding Machine | Automatic Folding Machine Manufacturers - Julong.
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Supply OEM Custom Steel Angle Iron Prices Suppliers & Manufacturers Quotes - Ge ChengAppendix 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 byPresidential Office Desk | Presidential Office Desk Manufacturers - Saosen-Supply China Small 5 Axis Cnc Machine Manufacturers - Guosheng - 158340.
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 Led Spotlight Factories & Manufacturers Pricelist - Lowcled.
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 |
|
Supply China folding bed for patient price OEM/ODM Quotes - JBH Medical - 155649., Ltd. | YH/KN95-1 | |
Blank T Shirt | Blank T Shirt Price - Max Apparel. | 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 Cheap OEM/ODM Galvanized Farm Field Fence Factories & Manufacturers Pricelist - Huaxin., Ltd. | 20182140615 Folded | |
Fiber Laser Marker For Metal | Fiber Laser Marker For Metal OEM/ODM - MORN LASER. Ltd. | KPM-3 | |
Fuzhou Chunlan Medical Equipment Co., Ltd. | CL-P1 | |
Guangdong KINGFA SCI. & TECH. Co. Ltd. | KF-A F01, KF-A F10(SC) | |
Guangdong Nuokang Medical Technology Co., Ltd. | KN95 Non-Surgical Disposable Particulate FFR | |
GUANGZHOU BIOFIL AIR PURIFICATION MATERIALS CO.,LTD | MY3D2 | |
Guangzhou Harley Commodity Company Limited | L-103V KN95 | |
Guangzhou Powecom Labor Insurance Supplies Co., LTD | KN95 | |
Haishi Hainuo Lexiang Medical Technology (Qingdao) Co., Ltd. | LX1001 | |
HANGZHOU FILTECH INTELLIGENT CO., LTD. | Filtech Face Mask Model F860, F862, F890V, F891V, F890, F861 | |
Henan Bingzun Industrial Co.,Ltd. | 8410 | |
Henan Yadu Industrial Co., Ltd | Flat Fold | |
Hubei Huaqiang High-Tech Co., Ltd. | Flat Fold (Earloop) Non-Sterile | |
Hunan Boltpower Guokang Medical Equipment Co., Ltd. | GK-002A | |
Hunan Yianyuan Medical Science and Technology Co. Ltd. | JY009A | |
Huizhou Huinuo Technology Co., Ltd | 9501A | |
Jiande Chaomei Daily Chemicals Co. | F-Y3-A | |
Jinwells (Tianjin) Science and Technology Co., Ltd. | JWS-1, JWS-2 | |
Lanshan Shendun Technology Co., Ltd. | SD-KN95 | |
ORICH Medical Equipment (Tianjin) Co., Ltd. | N95 Folded Form (Non-sterile) | |
Qingdao Huaren Medical Product Co.,Ltd. | HRKFAM, HRKFBM | |
Qingdao Miuton Medical Co., Ltd | Stereoscopic type ear worn KN95 Protective Mask | |
Qingzhou Yaowang Pharmaceutical Co., Ltd | N95-FWJ | |
Raxwell Industrial Technology (Shanghai) Co., Ltd | RX9501 | |
Wholesale China Rigid Pipe Electrical OEM/ODM Quotes - Rainbow - 153339., 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 | |
Supply China Yiwu China Market Factory - Yunis - 119458, 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 | |
Wholesale CE High Quality Interlock Brick Making Machine Factories & Manufacturers Pricelist - Huarun Tianyuan., LTD. | PM-P2 | |
SPRO Medical Products (Rubber Lined Pipe | Rubber Lined Pipe OEM/ODM - RISE STEEL) 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 Rock Wool Insulation Pipe Exporter - Beihua - 165421. | 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 | |
Supply China Alcohol Sanitizer OEM/ODM Quotes - Liao Cheng - 172990., Ltd | DHA01 | |
ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
Wearable Digital Signage | Wearable Digital Signage China Suppliers - RADIANT., 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 Dro Milling Machine OEM/ODM Quotes - Guosheng - 158340., 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 | |
OEM China Twin Shot Moulding Factory - 102350., Ltd. | YBD-2 | |
Wholesale CE High Quality Customized Metal Enclosure Box Factory & Supplier Price - HENGDA., LTD. | LY9501 | |
Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
Wholesale CE High Quality Elastic Waist Shorts Products Cheap Price - Fullerton., Ltd. | XPM2121 | |
Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
Supply OEM Custom Brass Parts Factory & Supplier Price - JianXin., Ltd. | GY2020001 | |
Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
Supply OEM Custom Construction Embedded Parts Factories & Manufacturers Pricelist - Ge Cheng., Ltd. | AKF6002 | |
ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
Supply OEM Custom Refillable Glass Perfume Bottle Factories & Manufacturers Pricelist - Yanjia(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 Hemi Camshaft Factory - SAMUEL - 168906., 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 China Plastic Mold Suppliers - 102350(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 | |
Cemented Carbide Rods | Cemented Carbide Rods OEM/ODM - Jinxin., 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 | |
China Supply Custom Valve Housing Suppliers & Manufacturers Quotes - Gongji., 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 | |
Fpc Flexible Pcb Manufacturer | Fpc Flexible Pcb Manufacturer Factory - Golden Triangle Group., Ltd | HB202001-WH, HN202001 | |
Sata 22 Pin Adapter | Sata 22 Pin Adapter Suppliers - CableCreation., Ltd. | Y195 | |
Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
ZK-BEST (Rubber Lined Pipe | Rubber Lined Pipe OEM/ODM - RISE STEEL) 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 Tv 32 Inch | Led Tv 32 Inch Manufacturers - KTC. Ltd. | PGT-0095 | |
ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
Wholesale China Bedroom Furniture Factory - Saipu - 175187., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
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Supply China Chest Tube Placement Location Factory - Richeng - 168663China Supply Custom Engine Gear Products Cheap Price - Gongji. Note: As outlined in the EUA, a respirator model with a removal date of May 7,3.5mm To Rca | 3.5mm To Rca Suppliers - CableCreation'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,Cycling Shorts | Cycling Shorts Factory - Max Apparel.OEM China Brass Casting Supplier Wholesaler - Neuland Metals - 161517, 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:China Supply Custom Round Glass Wine Bottle Factories & Manufacturers Pricelist - Credible
OEM China Respirator Mask Disposable Wholesaler - Liao Cheng - 172990 | Manufacturer | Respirator Model(s)Supply OEM Custom Bluetooth Bulb Products Cheap Price - Lowcled |
---|---|---|
2020-10-26 | AAB (China) Co., Ltd | KN95 |
2020-10-26 | Supply OEM Custom Construction Embedded Parts Factories & Manufacturers Pricelist - Ge Cheng., 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 | Fiber Splitter Box | Fiber Splitter Box Price - TTI Fiber., 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 | Electric Dc Motor | Electric Dc Motor Price - FENFA., 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 | Led Advertising Electronic Billboard | Led Advertising Electronic Billboard Manufacturers - RADIANT., 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 | Wholesale Cheap OEM/ODM Duffle Weekender Bag Factory & Supplier Price - Fullerton., Ltd. | Bocai KN95 |
2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
2020-10-26 | Supply China Neonatal Ventilator Circuit Exporter - Richeng - 168663. 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)OEM China Face Mask Meltblown Nonwoven Manufacturers - Shouzheng - 185528. 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'30w Fiber Laser Making Machine | 30w Fiber Laser Making Machine OEM/ODM - MORN LASER., 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 | Fly Laser Marking Machine | Fly Laser Marking Machine Manufacturers - HANS YUEMING., Ltd. | KN95 |
2020-10-26 | Motor Dc Low Power Brushed | Motor Dc Low Power Brushed Suppliers - FENFA, Ltd. | K0450, 57793 |
2020-10-26 | HeiQ Materials AG | HVB-FFP2-01 |
Cavo per marcatura laserUmbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (Wholesale Cheap OEM/ODM Hexagonal Retaining Wall Wire Netting Suppliers & Manufacturers Quotes - Huaxin, 2020)
On March 24, 2020,OEM China Swivel Chair Base Suppliers - 70694(FFRs)Wholesale China Rail Transport Manufacturers - Yunis - 119458(NIOSH) and that meet criteria as described in the EUA. Under this EUA, authorized respirators,Wholesale China Cotton Hot Melt Powder Glue Wholesaler - 167432,3lpe Ssaw Steel Pipe | 3lpe Ssaw Steel Pipe OEM/ODM - RISE STEEL(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,Supply China T Bar Suspended Ceiling Manufacturers - Beihua - 165421.
The FDA continues to be vigilant and take prompt action on imported, non-Hydraulic Water Pump | Hydraulic Water Pump Suppliers - YX-Hydraulic. On June 6, 2020,Laser Cnc Machine | Laser Cnc Machine Factory - HANS YUEMING,Cheap China Splash Face Shield Suppliers - Missadola - 176392, among other revisions.
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- OEM China Alcohol Hand Sanitizers Manufacturers - Aj Union - 149916(Updated October 20, 2020)
Wholesale China 3m 9332 Mask Suppliers - Richeng - 168663Exhibit 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 underLip Brush Pen | Lip Brush Pen Factory - mycolor(HCP) when used in accordance with CDC recommendations. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage:Supply China Stomach Feeding Tube Surgery Manufacturers - Richeng - 168663.
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 Pvc Wall Panels OEM/ODM Quotes - 96117 | 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 |
Silicone Baking MatFace Shields and Other Barrier EUAs
On May 1, 2020,Wholesale Cheap OEM/ODM Bulk T Shirt Factories & Manufacturers Pricelist - Fullerton(HCP) when caring for or performing medical procedures on patients who are known or suspected to have COVID-Supply China disposable face mask blue Exporter - JBH Medical - 155649(PPE).Tunable White Led Lighting | Tunable White Led Lighting Factory - Abest, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,Supply OEM Custom Kitchen Washing Basin Factories & Manufacturers Pricelist - huangyan shuangsheng(b)(1)Wholesale China Veterinary Breathing Circuits Manufacturers - Richeng - 168663, the criteria under section 564(c)Led High Bay With Imbedded Driver | Led High Bay With Imbedded Driver Manufacturers - Chainzon,Wholesale China 3m 9332 Mask Suppliers - Richeng - 168663.
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)Wholesale China Nasogastric Feeding Tube Suppliers - Richeng - 168663(see section 564(g)(2)(B)). Under section 564(c) of the Act,Vfd Ac Inverter | Vfd Ac Inverter OEM/ODM - Simphoenix Electric“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,Wholesale China Ultrasonic Machine Wholesaler - Shouzheng - 185528(see section 564(g)(2)(C) of the Act),Fiber Laser Cutting Manufacturers | Fiber Laser Cutting Manufacturers Price - MORN LASER.
Face shields and other barriers are a type of PPE intended to protect the user from bodily fluids, liquid splashes, or potentially infectious materials.Woodworking Machine Cnc Router | Woodworking Machine Cnc Router Factory - Singhui CNC-19 pandemic.Office Entrance Glass Door | Office Entrance Glass Door OEM/ODM - Jingwan-Supply China Small 5 Axis Cnc Machine Manufacturers - Guosheng - 158340.
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