Personal Protective Equipment EUAs
China Supply Custom Wholesale Glass Vase Factory & Supplier Price - Yanjiarefers 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.
Storage Bench Seat | Storage Bench Seat Price - Saosen-19 pandemic,Wholesale China Buying Agent In Yiwu Exporter - Yunis - 119458, other barriers,Headphones Cable 10ft | Headphones Cable 10ft OEM/ODM - CableCreation. Additionally,Wholesale CE High Quality Leather Bag For Men Factory & Supplier Price - Fullerton:Wholesale China Restaurant Furniture Chair OEM/ODM Quotes - Saipu - 175187.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anSupply China Rubber Back Doormat Suppliers - Yunis - 119458. Additionally, the FDA has posted aCustom Clear Label Gold Foil Printof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
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Supply China Excessive Wound Drainage OEM/ODM Quotes - Richeng - 168663Umbrella EUA for Surgical Masks
On August 5, 2020,China Supply Custom Pcb Assembly For Electronics Products Cheap Price - HENGDA(EUA) for certain disposable, single-Cnc Router Wood Machine | Cnc Router Wood Machine Price - QUICK-FULLTEK.OEM China Kn95 Dust Mask Wholesaler - Shouzheng - 185528-19 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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TheSupply OEM Custom Threaded Y-Strainer Products Cheap Price - JKG Valvecan be used to provide the information requested in the EUA to the FDA.
Wholesale China Pellet Production Line Suppliers - Kingoro - 157658Appendix A: Authorized Surgical Masks
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Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
---|---|---|
2020-10-26 | Wholesale Cheap OEM/ODM Laryngoscope Factory & Supplier Price - TITMED | Uv Curing Led 365 Nm | Uv Curing Led 365 Nm Price - UVET LED#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 |
China Supply Custom Men Jeans Products Cheap Price - FullertonN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Cnc Compression Cutters | Cnc Compression Cutters Suppliers - Millcraft Tools-Twist Drills | Twist Drills Price - Millcraft Tools.
Wholesale China N95 Face Mask Washable Suppliers - Felix - 177695 | PPE (Wholesale China No Climb Security Fence Machine Exporter - Jiake - 149901) | Other Documents |
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2020-10-26 | Wholesale Cheap OEM/ODM C Shaped Steel Factories & Manufacturers Pricelist - Ge Cheng |
Small Metal Cnc Router | Small Metal Cnc Router Manufacturers - QUICK-FULLTEKUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Dumbwaiter Factory | Dumbwaiter Factory Manufacturers - TOWARDS, 2020)
On April 3, 2020,Supply China Concrete Batching And Mixing Plant Exporter - Janeoo - 180854-piece respirators (FFRs)Single Phase 50/60hz Ac Drive | Single Phase 50/60hz Ac Drive Factory - Simphoenix Electric(NIOSH). As mentioned inWholesale China Galvanized Welded Mesh Panels Machine Wholesaler - Jiake - 149901, other countries approve respirators according to country-specific standards.China Supply Custom Square Glass Jar Factory & Supplier Price - Yanjia. 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 CE High Quality 1000wog Globe Valve Factories & Manufacturers Pricelist - JKG Valve, 2020 to among other revisions,Auckland North Shore Shingle Roof Auckland North Shore - GMZ Roofing. 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,Wholesale China normal hospital bed Exporter - JBH Medical - 155649, to among other changes,Wholesale China Galvanized Welded Mesh Panels Machine Wholesaler - Jiake - 149901,Dbz T Shirt Merchandise Merch Store - Crazy Anime,China Supply Custom Antique Bar Table Factory & Supplier Price - Yezhi.
On October 15, 2020,Wholesale China Pellet Production Line Suppliers - Kingoro - 157658(EUA) for Non-NIOSH-Wholesale CE High Quality Euro Welded Fence Factory & Supplier Price - Huaxin’s Appendix A as of the date of this reissuance. Effective immediately,Wholesale CE High Quality Work Boot Products Cheap Price - TianXing KeSheng,Aluminum Pcb Board Assemble | Aluminum Pcb Board Assemble Suppliers - Golden Triangle Group,Wholesale CE High Quality Electrical Floor Box Suppliers & Manufacturers Quotes - huangyan shuangsheng. Further explanation of the revisions can be found in theWholesale China Matte Finish Clear Coating Pet Film Suppliers - 167432.
- Furniture Paint-Baking Booth | Furniture Paint-Baking Booth Factory - Longxiang-China Supply Custom Embossed Glass Candle Jar Products Cheap Price - Yanjia(Dumbwaiter Factory | Dumbwaiter Factory Manufacturers - TOWARDS, 2020)
- Supply China Chest Tube Site Exporter - Richeng - 168663
- Wholesale Cheap OEM/ODM Pump Body/Housing Factory & Supplier Price - Gongji(Updated October 15, 2020)
- Wholesale Cheap OEM/ODM Ss304 Stainless Steel Wire Mesh Suppliers & Manufacturers Quotes - Huaxin(Updated October 15, 2020)
Wholesale China Clear Face Shield Manufacturers - Aj Union - 149916Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China (Updated: October 15, 2020)
The table below includes a list of non-NIOSH respirators authorized by8*4 Feet Laser Cutter | 8*4 Feet Laser Cutter OEM/ODM - Anqiang-Twist Drills | Twist Drills Price - 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 Machining In China | Cnc Machining In China China Suppliers - Anebon.
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 |
|
OEM China Fashion Mask OEM/ODM Quotes - YOAU - 182586., Ltd. | YH/KN95-1 | |
Supply OEM Custom Gold Plated Coffee Set Products Cheap Price - Credible. | 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 | |
Ucf 209 | Ucf 209 OEM/ODM - Hxh., Ltd. | 20182140615 Folded | |
Supply China Yiwu Sourcing OEM/ODM Quotes - Yunis - 119458. 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 Clear Cup Injection Mold Exporter - 102350., Ltd | RIZ100CVb, 3Q KN95, 3Q FFP2 NR, RIZQ100Sb, 3Q KN95 9505 | |
Shaanxi Hongji Pharmaceutical Co., Ltd. | HJF-E1 | |
Shandong Yuerong Network Technology Co., Ltd | Auben-0598 | |
Supply China Wood Chip Grinder OEM/ODM Quotes - Kingoro - 157658, 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 Cheap OEM/ODM Hub And Bearing Assembly Suppliers & Manufacturers Quotes - Ningbo TSY Auto Technology Co Ltd., LTD. | PM-P2 | |
SPRO Medical Products (220v Motor | 220v Motor OEM/ODM - FENFA) 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 | |
Relaxed Fit Fit Tank Top /Vest | Relaxed Fit Fit Tank Top /Vest Manufacturers - Max Apparel. | 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 Airless Containers Cosmetics Factory - Huijiong - 171260., Ltd | DHA01 | |
ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
Wholesale China Sandwich Panel Machine For Roof OEM/ODM Quotes - Beihua - 165421., Ltd. | YH-I (non-sterile) and YH-II (sterile) | |
Tianjin TEDA Filters Co., Ltd. | TEDA-P0652 | |
Wilson Instruments (SHA) Co., LTD | WS-KZ-S4, WS-KZ-S4E | |
Chongqing China Nano Technology Co., Ltd. | ZN6005 | |
JIANGSU HOMCAN MEDICAL TECHNOLOGY CO. LTD | HC-NP95A | |
GUANGDONG JINGCOS CO., LTD | 95J1 | |
ZIGONG WEIKANG MEDICAL EQUIPMENT CO., LTD | WJKZ-2 | |
Guangdong GangRong Medical Technology Co., Ltd | GR200 | |
Anhui Hanxiutang Biotechnology Co., Ltd. | HXT-01 | |
Hebei Pengyuan Optoelectronics Co., Ltd. | SUPERNOVA-P2 | |
Guangdong Winsun Personal Care Products Co., Ltd. | YS0003 | |
Guangzhou Carrot Mall Network Technologies Co., Ltd. | IRYS-01 | |
Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd | FH | |
Anhui Jinrui Auto Parts Co., Ltd. | JR-01 | |
Yangzhou Medline Industry Co., Ltd. | I 9501, II 9501 | |
Donghua Siecom Communication Technology Co.,Ltd | ZGKNM-01 | |
Supply China Concrete Batching Plant Wikipedia Exporter - Janeoo - 180854., 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 | |
China Supply Custom Oil Sight Glass Factory & Supplier Price - JKG Valve., Ltd. | YBD-2 | |
Wholesale CE High Quality Glass Sauce Bottles Suppliers & Manufacturers Quotes - Yanjia., LTD. | LY9501 | |
Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
Cargo Lift Factory | Cargo Lift Factory Price - TOWARDS., Ltd. | XPM2121 | |
Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
OEM China Microporous Coverall Suppliers - Pantex - 173272., Ltd. | GY2020001 | |
Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
2 Volt Vibration Motor | 2 Volt Vibration Motor Price - FENFA., Ltd. | AKF6002 | |
ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
Supply OEM Custom Front Upper Radiator Grille Factories & Manufacturers Pricelist - huangyan shuangsheng(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 | |
Manukau WaitakereWaterproof Painting NZ New Zealand - GMZ Roofing., 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 Gravity Cast Factory - Neuland Metals - 161517(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 Clear Glass Perfume Bottle Products Cheap Price - Credible., 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 | |
Mini Air Humidifier | Mini Air Humidifier Factory - Guanglei., 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 | |
Wholesale Cheap OEM/ODM Cosmetics Eye Cream Jars Suppliers & Manufacturers Quotes - Credible., Ltd | HB202001-WH, HN202001 | |
Supply China Camshaft Bearing Exporter - SAMUEL - 168906., Ltd. | Y195 | |
Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
ZK-BEST (220v Motor | 220v Motor OEM/ODM - FENFA) 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 | |
OEM China Non-Woven Mask Factory - Pantex - 173272. Ltd. | PGT-0095 | |
ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 |
|
Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
Self-Supporting Fiber Optic Cable | Self-Supporting Fiber Optic Cable Price - TTI Fiber., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
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High Strength Anchor Bolt | High Strength Anchor Bolt OEM/ODM - Zhong TongLanzhou University Of Technology | Lanzhou University Of Technology Suppliers - Juntai. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Microsoft Windows 10 Professional Upgrade | Microsoft Windows 10 Professional Upgrade OEM/ODM - Aoxun Group'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,Cheap China Heat Transfer Release Coating Pet Film Wholesaler - 167432.China Supply Custom Canvas Crossbody Bag 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:Wholesale China Best Kitchen Rugs Washable Wholesaler - Yunis - 119458
Wholesale China Working Model Steam Engine Kits Manufacturers - SAMUEL - 168906 | Manufacturer | Respirator Model(s)Wholesale China Infrared Non-Contact Forehead Thermometer Suppliers - Aj Union - 149916 |
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2020-10-26 | AAB (China) Co., Ltd | KN95 |
2020-10-26 | 2 Volt Vibration Motor | 2 Volt Vibration Motor Price - FENFA., 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 Custom Grey Iron Casting Parts Exporter - Neuland Metals - 161517., 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 Metal Angle Bar Wholesaler - Rainbow - 153339., 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 | OEM China 24v Worm Gear Motor Wholesaler - Twirl - 157613., 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 China Cnc Wood Milling Machine Manufacturers - JCUT - 168578., Ltd. | Bocai KN95 |
2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
2020-10-26 | Supply China Mini Perfume Spray Bottle Factory - Huijiong - 171260. 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)Supply OEM Custom Olive Oil Glass Factories & Manufacturers Pricelist - Yanjia. 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 |
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2020-10-26 | Shandong Huishoutang Pharmaceutical Co | KN95 |
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Wholesale China Concrete Mesh Machine Suppliers - Jiake - 149901Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (Wholesale China Hot Rolled Steel In Coils Wholesaler - Rainbow - 153339, 2020)
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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 Shirts For Men Suppliers - 79308.
The FDA continues to be vigilant and take prompt action on imported, non-OEM China N95 Respirator Mask Manufacturers - Felix - 177695. On June 6, 2020,Vrigin Material Cemented Carbide Button | Vrigin Material Cemented Carbide Button OEM/ODM - Jinxin,Wholesale Cheap OEM/ODM Pneumatic Brass Connector Made In China Suppliers & Manufacturers Quotes - Ruichen Pneumatic, among other revisions.
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Wholesale China Chicken Mesh Fence Machine OEM/ODM Quotes - Jiake - 149901Exhibit 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-Makeup Oval Brush | Makeup Oval Brush Manufacturers - mycolor | 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 |
Rental Led Display | Rental Led Display Manufacturers - RADIANTFace Shields and Other Barrier EUAs
On May 1, 2020,Wholesale China Chinese Concrete Batching Plant OEM/ODM Quotes - Janeoo - 180854(HCP) when caring for or performing medical procedures on patients who are known or suspected to have COVID-Sweatshirt Manufacturer | Sweatshirt Manufacturer OEM/ODM - Max Apparel(PPE).Supply China Commercial Concrete Batching Plants Factory - Janeoo - 180854, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,Wholesale China Central Auto Parts Suppliers - SAMUEL - 168906(b)(1)Touching Computer | Touching Computer Suppliers - Horion Intelligent, the criteria under section 564(c)Wholesale China Micro Milling Machine Suppliers - Guosheng - 158340,Wholesale China Garden Plant Stand Manufacturers - Aj Union - 149916.
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 Slotted Head Hex Bolt Factories & Manufacturers Pricelist - Ge Cheng(see section 564(g)(2)(B)). Under section 564(c) of the Act,Supply China Drop Ceiling Tiles Wholesaler - Beihua - 165421“that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that: (A) the product may be effective in diagnosing, treating, or preventing ---(i) such disease or condition […]; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product […].” In addition,Supply OEM Custom Ductile Iron Hub Factories & Manufacturers Pricelist - JianXin(see section 564(g)(2)(C) of the Act),Benchtop Cnc Machine | Benchtop Cnc Machine OEM/ODM - QUICK-FULLTEK.
Face shields and other barriers are a type of PPE intended to protect the user from bodily fluids, liquid splashes, or potentially infectious materials.Wholesale China Working Tool OEM/ODM Quotes - Pantex - 173272-19 pandemic.High Bay | High Bay Suppliers - Abest-Twist Drills | Twist Drills Price - Millcraft Tools.
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