Personal Protective Equipment EUAs
OEM China Plastic Manufacturing Companies Manufacturers - 102350refers 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.
Wood Machine Cnc Router | Wood Machine Cnc Router Factory - QUICK-FULLTEK-19 pandemic,China Supply Custom Gi Welded Wire Mesh Products Cheap Price - Huaxin, other barriers,Flex Pcb - Rigid Pcb | Flex Pcb - Rigid Pcb OEM/ODM - Golden Triangle Group. Additionally,Cemented Carbide Button | Cemented Carbide Button OEM/ODM - Jinxin:Sheet Metal Fiber Laser Cutting Machine | Sheet Metal Fiber Laser Cutting Machine Price - Ruijie.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including an50 Watt Led Flood Light | 50 Watt Led Flood Light Factory - Chainzon. Additionally, the FDA has posted aNeodymium Magnet Nzof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
- China Supply Custom Soft Seat Butterfly Valve Factories & Manufacturers Pricelist - JKG Valve
- Wholesale China Disposable Protective Facial Mask OEM/ODM Quotes - YOAU - 182586
- Fiber Optic Termination Box | Fiber Optic Termination Box Suppliers - TTI Fiber
- Hot Sell Spray Booth | Hot Sell Spray Booth Price - Longxiang
- Cotton Face Hand Towel
Supply China Face Shield For Hospital Manufacturers - Missadola - 176392Umbrella EUA for Surgical Masks
On August 5, 2020,China Supply Custom Front Left Lower Control Arm Factories & Manufacturers Pricelist - Ningbo TSY Auto Technology Co Ltd(EUA) for certain disposable, single-Wholesale CE High Quality High Quality Bluetooth Speaker Suppliers & Manufacturers Quotes - YIMI.OEM China Custom Surgical Mask Manufacturers - YOAU - 182586-19 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.
- Wholesale China Beer Bottle Exporter - Hoyer - 175219
- Supply China Performance Car Parts Suppliers - SAMUEL - 168906
- Wholesale CE High Quality Simple And Modern Sofa Suppliers & Manufacturers Quotes - Yezhi
TheAnime Swimsuit Merch Store & Shop - Crazy Animecan be used to provide the information requested in the EUA to the FDA.
Supply China Concrete Batching Plant Mixing Plant OEM/ODM Quotes - Janeoo - 180854Appendix A: Authorized Surgical Masks
Wood Cnc Router 3d | Wood Cnc Router 3d Factory - QUICK-FULLTEK-5 Axes Machining | 5 Axes Machining Suppliers - Anebon.
Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
---|---|---|
2020-10-26 | Supply China Cnc Machining Process Manufacturers - 82574 | Led High Bay Ul | Led High Bay Ul OEM/ODM - Chainzon#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 |
Acrylic Plastic Cutting Tools | Acrylic Plastic Cutting Tools Factory - Millcraft ToolsN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Supply China Grating Stair Machine Factory - Jiake - 149901-5 Axes Machining | 5 Axes Machining Suppliers - Anebon.
Wholesale CE High Quality Round Wood Chair Suppliers & Manufacturers Quotes - Yezhi | PPE (OEM China N95 Exporter - Pantex - 173272) | Other Documents |
---|---|---|
2020-10-26 | Optical Fiber Cable Terminal Box | Optical Fiber Cable Terminal Box OEM/ODM - TTI Fiber |
Supply China Large Wood Chipper Hire OEM/ODM Quotes - Kingoro - 157658Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Supply China 16mm Mineral Fiber Ceiling Tiles 16mm Exporter - Beihua - 165421, 2020)
On April 3, 2020,Wholesale Cheap OEM/ODM Two Way Ball Valve Suppliers & Manufacturers Quotes - JKG Valve-piece respirators (FFRs)Supply China Pvc Ceiling Panels Philippines OEM/ODM Quotes - 96117(NIOSH). As mentioned inWholesale China Cafe Chairs Suppliers - Saipu - 175187, other countries approve respirators according to country-specific standards.High Performance Frequency Converter Ac Drive | High Performance Frequency Converter Ac Drive Price - Simphoenix Electric. 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 Pvc Ceiling Panel OEM/ODM Quotes - Beihua - 165421, 2020 to among other revisions,Wholesale China Cnc Tool Changer Suppliers - JCUT - 168578. Additionally, the FDA, in collaboration with CDC NIOSH, is increasing surveillance and sampling of all respirators imported from China - all respirator shipments from China that come into the U.S. will be subject to random sampling and testing by CDC NIOSH to determine whether the respirator meets the expected particulate filtration standards.
On June 6,Supply OEM Custom Channel Beam Steel Products Cheap Price - Ge Cheng, to among other changes,Wholesale China Cold Rolled Steel Sheet OEM/ODM Quotes - Rainbow - 153339,OEM China Silver Pendant Wholesaler - 178101,Odm Flat Brush | Odm Flat Brush Manufacturers - mycolor.
On October 15, 2020,OEM China Ffp2 Respirator OEM/ODM Quotes - Yangtuo - 169136(EUA) for Non-NIOSH-Supply China 350z Aftermarket Parts Exporter - SAMUEL - 168906’s Appendix A as of the date of this reissuance. Effective immediately,Cheap China Skin Care OEM/ODM Quotes - Missadola - 176392,Wholesale China Expert Supplier Of Used Concrete Batch Plants Manufacturers - Janeoo - 180854,Malleable Iron Pipe Fitting | Malleable Iron Pipe Fitting Price - RISE STEEL. Further explanation of the revisions can be found in theSupply OEM Custom Spicer Bearing Factories & Manufacturers Pricelist - Ningbo TSY Auto Technology Co Ltd.
- Supply OEM Custom Food Storage Airtight Glass Jars Factories & Manufacturers Pricelist - Yanjia-Wholesale China Pvc Ceiling Panel 30cm Exporter - 96117(Supply China 16mm Mineral Fiber Ceiling Tiles 16mm Exporter - Beihua - 165421, 2020)
- Fiber Drop Cable | Fiber Drop Cable Manufacturers - TTI Fiber
- m.kseidon.com(Updated October 15, 2020)
- Wholesale China Concrete Mixing Plant Concrete Batching Plant Manufacturers - Janeoo - 180854(Updated October 15, 2020)
Wholesale Cheap OEM/ODM Opel Camshaft Factory & Supplier Price - JianXinAppendix 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 byShenzhen Makeup Brush Factory | Shenzhen Makeup Brush Factory Manufacturers - mycolor-5 Axes Machining | 5 Axes Machining Suppliers - Anebon.
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:Supply OEM Custom Galvanized Binding Wire Factory & Supplier Price - Huaxin.
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 OEM Custom 3d Panel Fence Factories & Manufacturers Pricelist - Huaxin., Ltd. | YH/KN95-1 | |
OEM China Designer Medical Mask Suppliers - Felix - 177695. | 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 | |
OEM China Plastic Manufacturing Companies Manufacturers - 102350., Ltd. | 20182140615 Folded | |
Wholesale Cheap OEM/ODM Casting Camshaft Products Cheap Price - JianXin. 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 Cheap OEM/ODM Beer Glass Cup Factory & Supplier Price - Credible., 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 | |
High Quality China Kn95 Silicone Mask Exporter - Felix - 177695, 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 China Medical Kn95 Factory - Missadola - 176392., LTD. | PM-P2 | |
SPRO Medical Products (Laser Cutter For Mdf | Laser Cutter For Mdf OEM/ODM - Anqiang) 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 | |
Turning Service | Turning Service Manufacturers - Anebon. | MP9011 | |
Anhui Zhongke Duling Commercial Appliance Co. Ltd | M-9501 | |
Dongguan Arun Industrial Co., LTD | KN95 N9 | |
GUANGDONG GOLDEN LEAVES TECHNOLOGY DEVELOPMENT CO., LTD. | 8862 KN95 | |
Guangdong Zhizhen Biological Medicine Co., Ltd. | KN95 Three-Dimensional Protective Face Mask | |
Guangzhou Nan Qi Xing Non-Woven Co., Ltd. | KN-1 Respirator | |
Guanyang Yunhan Textile Co., Ltd. | YH-9500 | |
Huizhou Green Communication Equipment Manufacturing Co., Ltd | G95200 Particle Filtering Half Mask | |
Jiangsu Yimao Filter Media Co., Ltd | 9570K, 9560K | |
Jinhua Jiadaifu Medical Supplies Co., Ltd. | Disposable Non-Medical Face Mask (KN95) | |
Zhengzhou Ruipu Medical Technology Co. Ltd | KN95 | |
Zhongkang Protective Equipment Technology (Guangzhou) Co., Ltd | ZK601; ZK626 | |
Jiangsu Jiaao Medical Technology Co., Ltd. | JA95-1 Filtering half mask | |
Liaoning Dalian Jieying Energy Saving Environmental Protection Technology Development Co., Ltd. | JY-FH-F, JY-FH | |
Wholesale China Plastic Moulding Industry Factory - 102350., Ltd | DHA01 | |
ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
Cheap China Aluminum Sheet Price 1100 OEM/ODM Quotes - Hanyu - 149407., 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 | |
Led Television | Led Television Price - Horion Intelligent., 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 | |
Stools | Stools Factory - Saosen., Ltd. | YBD-2 | |
China Supply Custom Assembly Pcb Products Cheap Price - HENGDA., LTD. | LY9501 | |
Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
Wholesale CE High Quality T8 Led Bulbs Factory & Supplier Price - Lowcled., Ltd. | XPM2121 | |
Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
Ble Ibeacons | Ble Ibeacons Manufacturers - Minew., Ltd. | GY2020001 | |
Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
China Supply Custom Galvanized Brackets Products Cheap Price - Ge Cheng., Ltd. | AKF6002 | |
ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
Supply China Mini Trigger Spray Bottle Wholesaler - Huijiong - 171260(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 CE High Quality Automotive Cable Assembly Products Cheap Price - HENGDA., 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 Respirator Face Mask Exporter - Missadola - 176392(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 | |
China Supply Custom Induction Heating Power Supply Factories & Manufacturers Pricelist - HENGDA., 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 | |
Cnc Router Cutting 1325 Atc | Cnc Router Cutting 1325 Atc Manufacturers - Singhui CNC., 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 | |
Supply OEM Custom Auto Gasket Kit Factories & Manufacturers Pricelist - Ningbo TSY Auto Technology Co Ltd., Ltd | HB202001-WH, HN202001 | |
OEM China Wall Covering Panels OEM/ODM Quotes - 96117., Ltd. | Y195 | |
Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
ZK-BEST (Laser Cutter For Mdf | Laser Cutter For Mdf OEM/ODM - Anqiang) 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 | |
Bearing 607 2rs | Bearing 607 2rs Suppliers - Hxh. Ltd. | PGT-0095 | |
ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
Supply China Chest Tube Drainage System OEM/ODM Quotes - Richeng - 168663., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
|
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Cnc Laser Cutter | Cnc Laser Cutter Factory - HANS YUEMINGSupply China Face Shield For Hospital Manufacturers - Missadola - 176392. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Supply OEM Custom Puncture Protection Shoe Products Cheap Price - TianXing KeSheng'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,Guantes Nitrilo | Guantes Nitrilo Manufacturers - SUNCEND SAFETY.Wholesale Cheap OEM/ODM 1/2" Welded 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:Wholesale China Meltblown Cloth Exporter - Shouzheng - 185528
OEM China Childrens Masks OEM/ODM Quotes - Yangtuo - 169136 | Manufacturer | Respirator Model(s)Wholesale Cheap OEM/ODM Double Layers Pcb Board Suppliers & Manufacturers Quotes - HENGDA |
---|---|---|
2020-10-26 | AAB (China) Co., Ltd | KN95 |
2020-10-26 | China Supply Custom Galvanized Brackets Products Cheap Price - 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 | Supply OEM Custom Security Chain Link Fence Factory & Supplier Price - Huaxin., 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 | Supply China Stomach Feeding Tube Surgery Manufacturers - Richeng - 168663., 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 | Hand Metal Detector | Hand Metal Detector Factory - Junhong., 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 | Supply China Cylinder Head Porting Exporter - SAMUEL - 168906., Ltd. | Bocai KN95 |
2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
2020-10-26 | Wholesale CE High Quality Forge Metal Factory & Supplier Price - JianXin. 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 A325m Bolt F10t Suppliers & Manufacturers Quotes - Ge Cheng. 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'OEM China Reusable N95 Respirator Mask Exporter - Felix - 177695., 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 |
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Supply China Good Dry Concrete Batching Plants Factory - Janeoo - 180854Exhibit 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 |
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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-820 Hollow Cup Motor | 820 Hollow Cup Motor OEM/ODM - FENFA | 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 |
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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)P1.9 Led Display Module Wholesale | P1.9 Led Display Module Wholesale Suppliers - RADIANT(see section 564(g)(2)(B)). Under section 564(c) of the Act,Supply China Miniature Milling Machine OEM/ODM Quotes - Guosheng - 158340“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 China 16 Foley Catheter Suppliers - Richeng - 168663(see section 564(g)(2)(C) of the Act),Gold Finder Underground | Gold Finder Underground Manufacturers - Junhong.
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