Personal Protective Equipment EUAs
Quality Chinese Products | Quality Chinese Products Factory - Anebonrefers 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.
Win 10 Home Key | Win 10 Home Key Factory - Newtown-19 pandemic,Wholesale China Medical Plastic Molding Wholesaler - 102350, other barriers,Tunnel Size X-Ray Luggage Scanner | Tunnel Size X-Ray Luggage Scanner Factory - Junhong. Additionally,High Quality China Surgical N95 OEM/ODM Quotes - Felix - 177695:Supply OEM Custom Mini Wine Bottle Factory & Supplier Price - Yanjia.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anCheap China Elastic Transparent Plastisol Ink Wholesaler - 167432. Additionally, the FDA has posted aShanghai LeadCloud Tech Co.of the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
- Guantes De Jebe | Guantes De Jebe Price - SUNCEND SAFETY
- China Supply Custom Endobag Suppliers & Manufacturers Quotes - TITMED
- Uc205 Bearing | Uc205 Bearing Manufacturers - Hxh
- Optical Fiber MPO-LC OM3 Cable Assembly | Optical Fiber MPO-LC OM3 Cable Assembly China Suppliers - INTCERA
- Patch Cord Fiber Optic | Patch Cord Fiber Optic Price - TTI Fiber
Mosquito Clothing Melbourne | Mosquito Clothing Melbourne Price - Special TextileUmbrella EUA for Surgical Masks
On August 5, 2020,Epon Olt Px20 | Epon Olt Px20 OEM/ODM - HDV(EUA) for certain disposable, single-Wholesale Cheap OEM/ODM Radiator Front Grill Factories & Manufacturers Pricelist - huangyan shuangsheng.Wholesale China Spray Glass Bottles OEM/ODM Quotes - Huijiong - 171260-19 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 Locker Group Expanded Mesh Machine Manufacturers - Jiake - 149901
- Cutting Tools Aluminum | Cutting Tools Aluminum OEM/ODM - Millcraft Tools
- OEM China Disposable Isolation Gowns Factory - Pantex - 173272
TheSupply China Glass Milk Jugs Exporter - Hoyer - 175219can be used to provide the information requested in the EUA to the FDA.
Wholesale China Glass Beverage Bottle Manufacturers - Hoyer - 175219Appendix A: Authorized Surgical Masks
Wholesale China Wound Drain Factory - Richeng - 168663-Supply OEM Custom Gauge Root Valve Products Cheap Price - JianXin.
Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
---|---|---|
2020-10-26 | China Supply Custom T Shirt Printing Factory & Supplier Price - Fullerton | 6805 2rs Bearing | 6805 2rs Bearing Manufacturers - Hxh#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 |
OEM China 3 Layer Mask Maker Manufacturers - Shouzheng - 185528N95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Led Tube Light Raw Material | Led Tube Light Raw Material OEM/ODM - Abest-Supply OEM Custom Gauge Root Valve Products Cheap Price - JianXin.
Wholesale Cheap OEM/ODM Glass Bottle Beverage Factory & Supplier Price - Yanjia | PPE (Supply China Silicone Foley Catheter Wholesaler - Richeng - 168663) | Other Documents |
---|---|---|
2020-10-26 | Wholesale China Face Mask Manufacturer Exporter - Richeng - 168663 |
China Supply Custom Hot Sauce Glass Bottles Products Cheap Price - YanjiaUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Wholesale CE High Quality Price Concrete Block Making Machine Suppliers & Manufacturers Quotes - Huarun Tianyuan, 2020)
On April 3, 2020,Supply China Travel Perfume Container Exporter - Huijiong - 171260-piece respirators (FFRs)Supply China Glass Oil Dropper Bottle OEM/ODM Quotes - Huijiong - 171260(NIOSH). As mentioned inMdf Laser Cutting Machine | Mdf Laser Cutting Machine Price - Ruijie, other countries approve respirators according to country-specific standards.2 By 3 Meters Led Screen Wholesale | 2 By 3 Meters Led Screen Wholesale Suppliers - RADIANT. 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 Extension Cord | Long Extension Cord Factory - CableCreation, 2020 to among other revisions,Led Lcd Super General Tv | Led Lcd Super General Tv Suppliers - KTC. 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 Ground Mounting Factory - Rainbow - 153339, to among other changes,Bench | Bench Manufacturers - Saosen,Garrett Metal Detector | Garrett Metal Detector Price - Junhong,OEM China Cosmetic Sample Jars OEM/ODM Quotes - Huijiong - 171260.
On October 15, 2020,Supply OEM Custom Front Wheel Bearings Factories & Manufacturers Pricelist - Ningbo TSY Auto Technology Co Ltd(EUA) for Non-NIOSH-Wet Rated Lighting | Wet Rated Lighting Factory - Abest’s Appendix A as of the date of this reissuance. Effective immediately,China Supply Custom Model Train Wheels Products Cheap Price - JianXin,China Supply Custom T8 Factories & Manufacturers Pricelist - Lowcled,Home Mini Craft Laser Cutting Machine | Home Mini Craft Laser Cutting Machine OEM/ODM - Ruijie. Further explanation of the revisions can be found in theOEM China Glass Jars And Containers Suppliers - Huijiong - 171260.
- Cnc Milling Parts | Cnc Milling Parts China Suppliers - Anebon-Supply OEM Custom Square Glass Spice Jar Factories & Manufacturers Pricelist - Yanjia(Wholesale CE High Quality Price Concrete Block Making Machine Suppliers & Manufacturers Quotes - Huarun Tianyuan, 2020)
- Wholesale Cheap OEM/ODM Polyamide Tubes Factory & Supplier Price - Ruichen Pneumatic
- OEM China Double Side Release Coated Pet Film Manufacturers - 167432(Updated October 15, 2020)
- Led Track Lighting Fixtures | Led Track Lighting Fixtures Suppliers - Abest(Updated October 15, 2020)
Supply China N95 Mask Surgical Wholesaler - Felix - 177695Appendix 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 Plastic Parts Manufacturing Companies OEM/ODM Quotes - 102350-Supply OEM Custom Gauge Root Valve Products Cheap Price - JianXin.
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 Small Electronic Enclosures Products Cheap Price - HENGDA.
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 |
|
Cheap China Aluminum Sheet Material 1060 Factory - Hanyu - 149407., Ltd. | YH/KN95-1 | |
OEM China Good Elasticity Water Base White Ink Exporter - 167432. | 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 China Fast Delivery Wholesaler - Shouzheng - 185528., Ltd. | 20182140615 Folded | |
Cnc Drilling Machines | Cnc Drilling Machines OEM/ODM - Singhui CNC. 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 | |
Forklift Bearing | Forklift Bearing Factory - Hxh., 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 Control Panel Metal Enclosure Box Products Cheap 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 Glass Jars Containers Suppliers & Manufacturers Quotes - Yanjia., LTD. | PM-P2 | |
SPRO Medical Products (Wholesale China Chicken Mesh Fence Machine OEM/ODM Quotes - Jiake - 149901) 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 | |
Manukau WaitakereLaminated Asphalt Roofing Shingles Manukau Waitakere - GMZ Roofing. | 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 Cheap OEM/ODM Power Bank Battery Charger Suppliers & Manufacturers Quotes - YIMI., Ltd | DHA01 | |
ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
Supply China Field Fence Making Macine Factory - Jiake - 149901., Ltd. | YH-I (non-sterile) and YH-II (sterile) | |
Tianjin TEDA Filters Co., Ltd. | TEDA-P0652 | |
Wilson Instruments (SHA) Co., LTD | WS-KZ-S4, WS-KZ-S4E | |
Chongqing China Nano Technology Co., Ltd. | ZN6005 | |
JIANGSU HOMCAN MEDICAL TECHNOLOGY CO. LTD | HC-NP95A | |
GUANGDONG JINGCOS CO., LTD | 95J1 | |
ZIGONG WEIKANG MEDICAL EQUIPMENT CO., LTD | WJKZ-2 | |
Guangdong GangRong Medical Technology Co., Ltd | GR200 | |
Anhui Hanxiutang Biotechnology Co., Ltd. | HXT-01 | |
Hebei Pengyuan Optoelectronics Co., Ltd. | SUPERNOVA-P2 | |
Guangdong Winsun Personal Care Products Co., Ltd. | YS0003 | |
Guangzhou Carrot Mall Network Technologies Co., Ltd. | IRYS-01 | |
Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd | FH | |
Anhui Jinrui Auto Parts Co., Ltd. | JR-01 | |
Yangzhou Medline Industry Co., Ltd. | I 9501, II 9501 | |
Donghua Siecom Communication Technology Co.,Ltd | ZGKNM-01 | |
OEM China Recycled Plastic Moulding Factory - 102350., 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 | |
Wholesale CE High Quality Glass Vase Gold Factory & Supplier Price - Yanjia., Ltd. | YBD-2 | |
Safety Pu Work Glove | Safety Pu Work Glove Suppliers - SUNCEND SAFETY., LTD. | LY9501 | |
Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
Wholesale China Cnc Machined Stainless Steel Parts OEM/ODM Quotes - 82574., Ltd. | XPM2121 | |
Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
Wholesale CE High Quality Pvc Coated Chain Link Mesh Products Cheap Price - Huaxin., Ltd. | GY2020001 | |
Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
Wholesale China Metal Roof Solar Mounts Manufacturers - Rainbow - 153339., Ltd. | AKF6002 | |
ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
Supply China Fold Dust Face Mask Suppliers - Missadola - 176392(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 | |
3 Phase Motor | 3 Phase Motor OEM/ODM - Simphoenix Electric., Ltd. | HT9510V, HT9510 | |
Quanzhou Caier Paper Co., Ltd. | CC001 | |
Shandong C.I.R.S. Garments Co., Ltd. | LSD008 | |
Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | |
Supply OEM Custom Petrol Station Lighting Suppliers & Manufacturers Quotes - 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 | |
Wholesale China Rice Husk Pellet Machine Factory - Kingoro - 157658., Ltd. | N95 Particulate Respirator (Xier) | |
Hui Zhou Tian Chang Industrial Co., Ltd. | N002-AW | |
Jingzhou Strong Sciences & Technology Development Co.,ltd | ST-A9502, A9507 | |
Lu’an Bi Hai Protective Equipment Co., Ltd. | BH2020 | |
Naton Medical Protective Mask (Zhuozhou) Co., Ltd | FS9501-L, FS9501-M, FS9501-S; FS9901-L, FS9901-M, FS9901-S | |
Deli Group Co., LTD. | ET30000 | |
DONGGUAN AOXING AUDIO VISUAL EQUIPMENT CO.,LTD | AX-KF95 | |
Guangdong Languan Medical Biotechnology Co., Ltd. | LGKN95 | |
Wuhan Zonsen Medical Products Co., Ltd. | ZSFM-01, ZSFM-02 | |
Zhejiang Dongmeng Medical Equipment Co., LTD | EYTV139110051-02 | |
Regina Miracle (Shenzhen) Ltd. | RM2020 MA-08 | |
Violet Home Textile Technology Co., Ltd. | ZLL377 | |
Guangdong Willing Technology Corporation | WL-01 | |
Wholesale China Machine A Pellet Suppliers - Kingoro - 157658., 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 | |
China Supply Custom Luxury Italian Leather Sofa Factory & Supplier Price - Yezhi., Ltd | HB202001-WH, HN202001 | |
Wholesale China Non Slip Runner For Kitchen OEM/ODM Quotes - Yunis - 119458., Ltd. | Y195 | |
Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
ZK-BEST (Wholesale China Chicken Mesh Fence Machine OEM/ODM Quotes - Jiake - 149901) 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 Foley Catheter Syringe Manufacturers - Richeng - 168663. Ltd. | PGT-0095 | |
ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
Original Vector Control Invt Inverter | Original Vector Control Invt Inverter Manufacturers - Simphoenix Electric., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
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Best Portable Air Purifier For Mold | Best Portable Air Purifier For Mold OEM/ODM - Guanglei(Wholesale China 100% Silicone Flat Fluted Drainage Tube OEM/ODM Quotes - Richeng - 168663)
Bluetooth 4.0 Tag | Bluetooth 4.0 Tag Manufacturers - MinewSupply China Semi Automatic Chain Link Fencing Machine Suppliers - Jiake - 149901. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Wholesale CE High Quality Drop Forged Steel Products Cheap Price - JianXin'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 OEM Custom Square Glass Spice Jar Factories & Manufacturers Pricelist - Yanjia.China Supply Custom Diamond Wire Mesh Factories & Manufacturers Pricelist - Huaxin, 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:Cnc Company | Cnc Company OEM/ODM - Anebon
3d Engraving Cnc Machine | 3d Engraving Cnc Machine Price - QUICK-FULLTEK | Manufacturer | Respirator Model(s)Electric Coffee Bike | Electric Coffee Bike Factory - GANGTING DIANCHE |
---|---|---|
2020-10-26 | AAB (China) Co., Ltd | KN95 |
2020-10-26 | Wholesale China Metal Roof Solar Mounts Manufacturers - Rainbow - 153339., 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 | Supply China Enco Benchtop Milling Machine OEM/ODM Quotes - Guosheng - 158340., 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 Cheap OEM/ODM Army Boot Products Cheap Price - TianXing KeSheng., 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 | Wholesale China Dc Worm Gear Motor Encoder Exporter - 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 CE High Quality Best Small Portable Speakers Factory & Supplier Price - YIMI., Ltd. | Bocai KN95 |
2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
2020-10-26 | Wholesale Makeup Brushes Sets | Wholesale Makeup Brushes Sets Factory - mycolor. LTD | YMS-AN95 |
2020-10-26 | Huizhou Huinuo Technology Co., LTD | HV-N White 9501B |
2020-10-26 | Huizhou Jiahe Cubic Technology Co., LTD | KN95 |
2020-10-26 | Huizhou Lexuslance Technology Co. Ltd. | LK 003 |
2020-10-26 | Improve Medical (Hunan) Co., Ltd. | PPDS Disposable Protective Respirator Strap Headband, PPDS Disposable Protective Respirator Ear Hook |
2020-10-26 | Jiangsu Weichuangli New Materials Co., Ltd. | WCL-0075 |
2020-10-26 | Jiangxi Hornet Industrial Co. Ltd. | S-KN95 |
2020-10-26 | Jiangxi Yifengyuan Biological Engineering Co., Ltd. | N95, KN95 |
2020-10-26 | Jinan Vhold Co., LTD | VH-95 |
2020-10-26 | Juntech (Jiaxing)Wholesale CE High Quality Top Ranked Bluetooth Speakers Products Cheap Price - YIMI. 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'50 Watt Led Flood Light | 50 Watt Led Flood Light Suppliers - Chainzon., Ltd | Purism KN95 |
2020-10-26 | Shandong Huishoutang Pharmaceutical Co | KN95 |
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MTP Cassettes Fiber Patch Panel | MTP Cassettes Fiber Patch Panel OEM/ODM - INTCERAExhibit 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-China Supply Custom Wooden Packing Cupping Factories & Manufacturers Pricelist - Credible | 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 Metal Fabrication | Custom Metal Fabrication OEM/ODM - AnebonFace 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)Wholesale CE High Quality Bluetooth Speaker Pcba Factory & Supplier Price - HENGDA(see section 564(g)(2)(B)). Under section 564(c) of the Act,Work Gloves Mechanic Gloves | Work Gloves Mechanic Gloves Factory - SUNCEND SAFETY“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,Guantes Cocina | Guantes Cocina OEM/ODM - SUNCEND SAFETY(see section 564(g)(2)(C) of the Act),Cnc Laser Cutting Machine Price | Cnc Laser Cutting Machine Price OEM/ODM - HANS YUEMING.
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