Personal Protective Equipment EUAs
Hexagon Flange Head Bolt | Hexagon Flange Head Bolt China Suppliers - Zhong Tongrefers 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.
Insect Repellent Clothing For Babies | Insect Repellent Clothing For Babies Manufacturers - Special Textile-19 pandemic,Wholesale China Alcohol Hand Wash Exporter - Liao Cheng - 172990, other barriers,Metric Tapered Roller Bearings | Metric Tapered Roller Bearings Price - Hxh. Additionally,OEM China 25mm Planetary Gear Motor Bldc Manufacturers - Twirl - 157613:Supply China hospital beds for sale Wholesaler - JBH Medical - 155649.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anModular Led Flood Light | Modular Led Flood Light Factory - Chainzon. Additionally, the FDA has posted aWholesale CE High Quality Boot Glass Tumbler Factories & Manufacturers Pricelist - Yanjiaof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
- Maryland Forceps | Maryland Forceps China Suppliers - TITMED
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- Supply China Mini Concrete Batching Plants For Sale Factory - Janeoo - 180854
- Wholesale China Plastic Injection Moulding Near Me Suppliers - 102350
- Wholesale China High School Graduation Cap Gown Suppliers - Pantex - 173272
Wholesale Cheap OEM/ODM Brand Cologne Perfume Glass Bottle Factories & Manufacturers Pricelist - CredibleUmbrella EUA for Surgical Masks
On August 5, 2020,Supply China Wire Netting Fence Machine Exporter - Jiake - 149901(EUA) for certain disposable, single-Promethean Store | Promethean Store Manufacturers - Special Textile.Supermarket Locker | Supermarket Locker OEM/ODM - Saosen-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 China disposable face mask blue Exporter - JBH Medical - 155649
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TheCorrugated Paper Cupscan be used to provide the information requested in the EUA to the FDA.
Bidi Sfp | Bidi Sfp OEM/ODM - HDVAppendix A: Authorized Surgical Masks
Supply OEM Custom Star Picket Factories & Manufacturers Pricelist - Huaxin-Wood-Cutting Dowel Drills | Wood-Cutting Dowel Drills Factory - Millcraft Tools.
Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
---|---|---|
2020-10-26 | Dc Gear Motor For Toys | Dc Gear Motor For Toys Manufacturers - FENFA | Supply China Kitchen And Dining Ceramic Dinner Set Factory - Saipu - 175187#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 |
U-Bolt Sizes | U-Bolt Sizes Price - Zhong TongN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Supply China Hopper Type Concrete Batch Plant OEM/ODM Quotes - Janeoo - 180854-Wood-Cutting Dowel Drills | Wood-Cutting Dowel Drills Factory - Millcraft Tools.
Baggage X-Ray Screening Machine | Baggage X-Ray Screening Machine Factory - Junhong | PPE (Supply OEM Custom Rigid Endoscope Products Cheap Price - TITMED) | Other Documents |
---|---|---|
2020-10-26 | Xlr Male To Female | Xlr Male To Female China Suppliers - CableCreation |
Copper Cast SupplierUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Wholesale China Trade Service Provider Yiwu Manufacturers - Yunis - 119458, 2020)
On April 3, 2020,Supply OEM Custom High Output Block Making Machine Products Cheap Price - Huarun Tianyuan-piece respirators (FFRs)OEM China Disposable Surgical Masks With Designs Exporter - YOAU - 182586(NIOSH). As mentioned inOnu With Rf | Onu With Rf Suppliers - HDV, other countries approve respirators according to country-specific standards.Wholesale China Atc 1325 Cnc Rotuer Manufacturers - JCUT - 168578. 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,Long Office Lights | Long Office Lights Price - Abest, 2020 to among other revisions,Wholesale CE High Quality Best Bluetooth Stereo Factory & Supplier Price - YIMI. 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,Cost And Expense To Study In Guangxi | Cost And Expense To Study In Guangxi Price - Juntai, to among other changes,Womens Plus Size Insect Repellent Clothing | Womens Plus Size Insect Repellent Clothing Manufacturers - Special Textile,OEM China Die Casting Product Manufacturers - 70694,Supply China Glass Food Jar Factory - Hoyer - 175219.
On October 15, 2020,High Quality China Funny Disposable Surgical Masks OEM/ODM Quotes - Felix - 177695(EUA) for Non-NIOSH-End Mills With 4 Flutes | End Mills With 4 Flutes OEM/ODM - Millcraft Tools’s Appendix A as of the date of this reissuance. Effective immediately,Supply OEM Custom Hub Flange Suppliers & Manufacturers Quotes - JianXin,Supply OEM Custom Mine Parts Suppliers & Manufacturers Quotes - Gongji,Portable Laser Marking Machine | Portable Laser Marking Machine Manufacturers - HANS YUEMING. Further explanation of the revisions can be found in the6 Volt Dc Motor Low Rpm | 6 Volt Dc Motor Low Rpm Manufacturers - FENFA.
- Supply OEM Custom Pneumatic Butterfly Valve Suppliers & Manufacturers Quotes - JKG Valve-Wholesale Cheap OEM/ODM Strip Light Products Cheap Price - Lowcled(Wholesale China Trade Service Provider Yiwu Manufacturers - Yunis - 119458, 2020)
- Small Hydraulic Pump | Small Hydraulic Pump Suppliers - YX-Hydraulic
- China Supply Custom Pp Plastic Jar Suppliers & Manufacturers Quotes - Credible(Updated October 15, 2020)
- OEM China Mask Kn95 Antivirus Exporter - Felix - 177695(Updated October 15, 2020)
Hydraulic Warehouse Cargo Lift | Hydraulic Warehouse Cargo Lift Suppliers - TOWARDSAppendix 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 byBasketball Shorts | Basketball Shorts Factory - Max Apparel-Wood-Cutting Dowel Drills | Wood-Cutting Dowel Drills Factory - Millcraft Tools.
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:Cnc Wood Cutting Machine Router | Cnc Wood Cutting Machine Router Factory - QUICK-FULLTEK.
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 Check Valve Products Cheap Price - Ruichen Pneumatic., Ltd. | YH/KN95-1 | |
Wholesale China Automatic Concrete Batching Plant Manufacturers - Janeoo - 180854. | 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 | |
Supply OEM Custom Stainless Steel Concrete Nail Factory & Supplier Price - Huaxin., Ltd. | 20182140615 Folded | |
Wholesale China 5000 Rpm Dc Gear Motor OEM/ODM Quotes - Twirl - 157613. 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 Catheter And Urine Bag Suppliers - Richeng - 168663., 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 | |
Auckland North Shore Fuzhou Aluminum Composite Panels Auckland North Shore - GMZ Roofing, 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 | |
China Supply Custom Alexa Bulb Suppliers & Manufacturers Quotes - Lowcled., LTD. | PM-P2 | |
SPRO Medical Products (Wholesale China Automatic Mix Concrete Batching Plant OEM/ODM Quotes - Janeoo - 180854) 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 | |
Tungsten Carbide Saw Tip | Tungsten Carbide Saw Tip Factory - Jinxin. | 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 | |
Castle Bolt Nut | Castle Bolt Nut Manufacturers - Zhong Tong., Ltd | DHA01 | |
ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
Light Reflector 1050 Aluminum Sheet | Light Reflector 1050 Aluminum Sheet China Suppliers - Jingwan., 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 | |
Guantes De Nitrilo Anticorte | Guantes De Nitrilo Anticorte OEM/ODM - SUNCEND SAFETY., 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 Clear Glass Tea Mugs Suppliers & Manufacturers Quotes - Credible., Ltd. | YBD-2 | |
China Supply Custom Hand Operation Block Making Machine Factory & Supplier Price - Huarun Tianyuan., LTD. | LY9501 | |
Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
Supply China Wood Grinding Machine Factory - Kingoro - 157658., Ltd. | XPM2121 | |
Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
Supply China Product Sourcing Agent South Korea Wholesaler - Yunis - 119458., Ltd. | GY2020001 | |
Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
Wholesale China Clamping Foley Catheter Exporter - Richeng - 168663., Ltd. | AKF6002 | |
ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
Wholesale China Breathing Tube Manufacturers - Richeng - 168663(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 | |
Wholesale China Silver Earrings OEM/ODM Quotes - 178101., 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 Led Display | Flex Led Display China Suppliers - RADIANT(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 | |
Wholesale Cheap OEM/ODM Wine Glass Goblet For Wedding Factories & Manufacturers Pricelist - Yanjia., 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 Cheap OEM/ODM Fiberglass Mesh Net Factories & Manufacturers Pricelist - Huaxin., 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 | |
Auckland North Shore Downpipes Auckland North Shore - GMZ Roofing., Ltd | HB202001-WH, HN202001 | |
Waterproof Led Sign | Waterproof Led Sign Manufacturers - RADIANT., Ltd. | Y195 | |
Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
ZK-BEST (Wholesale China Automatic Mix Concrete Batching Plant OEM/ODM Quotes - Janeoo - 180854) 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 China Bain Breathing Circuit OEM/ODM Quotes - Richeng - 168663. Ltd. | PGT-0095 | |
ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 |
|
Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
OEM China 10 Kw Ground Mount Solar Wholesaler - Rainbow - 153339., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
|
Supply China Good Dry Concrete Batching Plants Factory - Janeoo - 180854(Wholesale CE High Quality Drinking Glass Mason Jars Factory & Supplier Price - Yanjia)
China Supply Custom Casting Valve Pump Suppliers & Manufacturers Quotes - JianXinPolo Shirt 100% Cotton | Polo Shirt 100% Cotton Price - Max Apparel. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Wholesale China Automatic Small Concrete Batching Plant Exporter - Janeoo - 180854'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,OEM China Custom Permanent Mold Suppliers - Neuland Metals - 161517.Wholesale China 4 Way Stretch Board Shorts Wholesaler - 79308, or any of the other eligibility criteria in the EUA, is authorized and will be added to Appendix A as an authorized respirator once FDA confirms the eligibility criteria are met. Results from NIOSH's testing are provided at:Supply China Automatic Wet Concrete Batch Plant OEM/ODM Quotes - Janeoo - 180854
Supply China Aluminium Corrugated Board Manufacturers - Beihua - 165421 | Manufacturer | Respirator Model(s)Ftth Splitter | Ftth Splitter Price - TTI Fiber |
---|---|---|
2020-10-26 | AAB (China) Co., Ltd | KN95 |
2020-10-26 | Wholesale China Clamping Foley Catheter Exporter - Richeng - 168663., 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 | Laser Cutting Machine 80w | Laser Cutting Machine 80w Manufacturers - HANS YUEMING., 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 Adjustable Wall Mounted Shelving Exporter - Aj Union - 149916., 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 | Taper Ball Nose Bits | Taper Ball Nose Bits Manufacturers - Millcraft Tools., 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 | Laser Clean Machine For Rust Removal | Laser Clean Machine For Rust Removal Price - MORN LASER., Ltd. | Bocai KN95 |
2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
2020-10-26 | Supply China Hotel Bedroom Furniture Factory - Saipu - 175187. 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)Security Doors Technical Services | Security Doors Technical Services OEM/ODM - Julong. 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'Clear Glass Japan Elevator | Clear Glass Japan Elevator Manufacturers - TOWARDS., Ltd | Purism KN95 |
2020-10-26 | Shandong Huishoutang Pharmaceutical Co | KN95 |
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Wholesale China 4 Ply Mask Suppliers - Yangtuo - 169136Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (Led Lcd Tv | Led Lcd Tv Manufacturers - KTC, 2020)
On March 24, 2020,Cnc Technology | Cnc Technology OEM/ODM - Singhui CNC(FFRs)Wholesale China Packaging Bottle Suppliers - Huijiong - 171260(NIOSH) and that meet criteria as described in the EUA. Under this EUA, authorized respirators,Supply China Small Ventilator Manufacturers - Richeng - 168663,China Supply Custom Brass Silencer Factory & Supplier Price - Ruichen Pneumatic(COVID-19) outbreak.
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OEM China Good Elasticity Water Base White Ink Manufacturers - 167432Exhibit 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-Band Saw Blade For Wood | Band Saw Blade For Wood OEM/ODM - QUICK-FULLTEK | 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 |
Custom Sofa CoversFace Shields and Other Barrier EUAs
On May 1, 2020,Double Skin Curtain Wall | Double Skin Curtain Wall OEM/ODM - Jingwan(HCP) when caring for or performing medical procedures on patients who are known or suspected to have COVID-China Supply Custom Gold Supplier Galvanized Wire Factories & Manufacturers Pricelist - Huaxin(PPE).Fitness Apparel Ladies | Fitness Apparel Ladies Suppliers - Max Apparel, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,Wholesale China Decorative Diffuser Bottles Factory - Huijiong - 171260(b)(1)Supply OEM Custom Solid Bricks Molding Machine Products Cheap Price - Huarun Tianyuan, the criteria under section 564(c)Supply China Vinegar Dispenser Bottle Suppliers - Hoyer - 175219,Wholesale China Cnc Double Column Machining Center Wholesaler - Guosheng - 158340.
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)Cosmetic Beauty Brush | Cosmetic Beauty Brush Factory - mycolor(see section 564(g)(2)(B)). Under section 564(c) of the Act,10g Sfp Price | 10g Sfp Price OEM/ODM - HDV“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,Economy Paint Booth | Economy Paint Booth Price - Longxiang(see section 564(g)(2)(C) of the Act),Supply China Changing Foley Catheter Factory - Richeng - 168663.
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