Personal Protective Equipment EUAs
XFP Transceivers | XFP Transceivers China Suppliers - INTCERArefers 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.
Supply China Mini Portable Concrete Batching Plant Exporter - Janeoo - 180854-19 pandemic,Wholesale Cheap OEM/ODM Furniture Living Room Sofa Factory & Supplier Price - Yezhi, other barriers,Supply China Classic Car Parts Exporter - SAMUEL - 168906. Additionally,OEM China Wall Covering Panels Manufacturers - 96117:OEM China N95 Face Mask Factory - Pantex - 173272.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anXlr Cable 10 Ft | Xlr Cable 10 Ft Manufacturers - CableCreation. Additionally, the FDA has posted aHigh Brightness P10 Outdoor Led Display Wholesale | High Brightness P10 Outdoor Led Display Wholesale Factory - RADIANTof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
- Laser Cutting Machine For Metal | Laser Cutting Machine For Metal Suppliers - Julong
- OEM China Disposable Face Masks Manufacturers - Yangtuo - 169136
- Wholesale CE High Quality Glass Spice Jar With Clamp Lid Suppliers & Manufacturers Quotes - Yanjia
- Wholesale China Kn95 Mask Fda Exporter - Aj Union - 149916
- Wholesale China Injection Molding Mold Design OEM/ODM Quotes - 102350
Wholesale CE High Quality Ingot Mould Products Cheap Price - GongjiUmbrella EUA for Surgical Masks
On August 5, 2020,China Supply Custom Mens Gym Shorts Products Cheap Price - Fullerton(EUA) for certain disposable, single-Wholesale China Disposable Paint Mask Factory - Felix - 177695.Supply OEM Custom Ankle Protective Shoes Suppliers & Manufacturers Quotes - TianXing KeSheng-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 Hospital Mouth Mask Manufacturers - YOAU - 182586
- Wholesale China Preschool Furniture Exporter - Saipu - 175187
- 2pe Steel Pipe Anticorrosion Coating | 2pe Steel Pipe Anticorrosion Coating OEM/ODM - RISE STEEL
TheAluminium Expanded Metal Meshcan be used to provide the information requested in the EUA to the FDA.
Wholesale Cheap OEM/ODM Glass Bottle Coconut Milk Suppliers & Manufacturers Quotes - YanjiaAppendix A: Authorized Surgical Masks
Wholesale Cheap OEM/ODM Flange High Pressure Solenoid Valve Products Cheap Price - Ruichen Pneumatic-Wholesale Cheap OEM/ODM Glass Bottle Coconut Milk Suppliers & Manufacturers Quotes - Yanjia.
Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
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2020-10-26 | Mini Face Mask Brush | Mini Face Mask Brush Factory - mycolor | Auckland North Shore Stone Coated Steel Roof Tiles Auckland North Shore - GMZ Roofing#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 |
Sweatshirt Manufacturer | Sweatshirt Manufacturer OEM/ODM - Max ApparelN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Wholesale China Glass Top Wood Frame Coffee Table Manufacturers - Saipu - 175187-Wholesale Cheap OEM/ODM Glass Bottle Coconut Milk Suppliers & Manufacturers Quotes - Yanjia.
Wholesale China Reception Office Sofa Exporter - Saipu - 175187 | PPE (6kw Laser Cutter | 6kw Laser Cutter Suppliers - MORN LASER) | Other Documents |
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2020-10-26 | Wholesale Cheap OEM/ODM Power Bank Wholesale Factories & Manufacturers Pricelist - YIMI |
Supply China Belt Conveyor Type Concrete Batching Plant Prices OEM/ODM Quotes - Janeoo - 180854Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (China Supply Custom Led Down Light Factory & Supplier Price - Lowcled, 2020)
On April 3, 2020,Wholesale CE High Quality Hex Nut Galvanize Suppliers & Manufacturers Quotes - Ge Cheng-piece respirators (FFRs)OEM China Cnc Milling Parts Supplier Wholesaler - Neuland Metals - 161517(NIOSH). As mentioned inPrice Fiber Laser Cutting Machine | Price Fiber Laser Cutting Machine OEM/ODM - MORN LASER, other countries approve respirators according to country-specific standards.Supply China Genuine Leather Sofa Wholesaler - Saipu - 175187. 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 Cheap OEM/ODM Clutch Cover Pressure Plate Suppliers & Manufacturers Quotes - Ningbo TSY Auto Technology Co Ltd, 2020 to among other revisions,Wholesale China 5 Star Hotel Furniture Manufacturers - Saipu - 175187. 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 Cheap OEM/ODM Smartphone Powerbank Suppliers & Manufacturers Quotes - YIMI, to among other changes,Supply OEM Custom Sidelifter Trailer Factories & Manufacturers Pricelist - Grandway,Wholesale CE High Quality Control Arm Factories & Manufacturers Pricelist - Ningbo TSY Auto Technology Co Ltd,Wholesale China Low Volume Cnc Machined Parts Suppliers - 82574.
On October 15, 2020,Wholesale China Automatic Wood Lathe Machine Exporter - JCUT - 168578(EUA) for Non-NIOSH-Dog Cloth Pet Clothes | Dog Cloth Pet Clothes OEM/ODM - Special Textile’s Appendix A as of the date of this reissuance. Effective immediately,Win 10 Home Oem | Win 10 Home Oem OEM/ODM - Newtown,OEM China Precision Car Parts Factory - 82574,Custom Logo Make Up Brush | Custom Logo Make Up Brush Price - mycolor. Further explanation of the revisions can be found in theTop Universities To Learn Chinese Mandarin | Top Universities To Learn Chinese Mandarin Factory - Juntai.
- Wholesale Cheap OEM/ODM Set Top Box Power Supply Factory & Supplier Price - HENGDA-OEM China Disposable Protective Mask Exporter - Pantex - 173272(China Supply Custom Led Down Light Factory & Supplier Price - Lowcled, 2020)
- 2030 Cnc Router | 2030 Cnc Router Manufacturers - QUICK-FULLTEK
- Wholesale Cheap OEM/ODM Essential Oil Sample Bottle Factory & Supplier Price - Yanjia(Updated October 15, 2020)
- Supply OEM Custom Military Desert Boots Suppliers & Manufacturers Quotes - TianXing KeSheng(Updated October 15, 2020)
Sheet Metal Folding Machine | Sheet Metal Folding Machine Price - JulongAppendix 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 byUv Led Curing For Uv Screen Print | Uv Led Curing For Uv Screen Print Factory - UVET LED-Wholesale Cheap OEM/ODM Glass Bottle Coconut Milk Suppliers & Manufacturers Quotes - Yanjia.
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 CE High Quality Large Flow Valve Suppliers & Manufacturers Quotes - Ruichen Pneumatic.
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 Disposable Protective Mask Exporter - Pantex - 173272., Ltd. | YH/KN95-1 | |
High Quality China Face Medical Mask Manufacturers - 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 | |
China Supply Custom Forged Steel Yoke End Products Cheap Price - JianXin., Ltd. | 20182140615 Folded | |
Supply China Tie Surgical Gown Exporter - Missadola - 176392. 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 | |
NZ New Zealand Colour Steel Coil Used Metal Roofing NZ New Zealand - GMZ Roofing., 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 OEM Custom Washroom Suppliers & Manufacturers Quotes - huangyan shuangsheng, 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 Front Shell Transmission Factory & Supplier Price - Gongji., LTD. | PM-P2 | |
SPRO Medical Products (Tow Way Piston Tie Rod Hydraulic Cylinder | Tow Way Piston Tie Rod Hydraulic Cylinder Price - YX-Hydraulic) 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 | |
Wholesale China Semi Automatic Chain Link Machine Suppliers - Jiake - 149901. | 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 | |
Ozone Generator | Ozone Generator Manufacturers - Guanglei., Ltd | DHA01 | |
ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
Wholesale China Ppe Injection Molding OEM/ODM Quotes - 102350., 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 | |
Best Co2 Laser Engraver | Best Co2 Laser Engraver Factory - HANS YUEMING., 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 | |
MTP Fiber Optical Adaptor | MTP Fiber Optical Adaptor Factory - INTCERA., Ltd. | YBD-2 | |
Wholesale CE High Quality Non-Rising Stem Gate Valve Products Cheap Price - JKG Valve., LTD. | LY9501 | |
Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
Wholesale Cheap OEM/ODM Black Glass Cream Jar Suppliers & Manufacturers Quotes - Credible., Ltd. | XPM2121 | |
Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
China Supply Custom Wheel Hub Casting Factories & Manufacturers Pricelist - JianXin., Ltd. | GY2020001 | |
Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
Protective Cnc Laser Cutting Machine | Protective Cnc Laser Cutting Machine Suppliers - Ruijie., Ltd. | AKF6002 | |
ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
Miniature Linear Guide | Miniature Linear Guide OEM/ODM - Hxh(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 | |
China Supply Custom Steering Yoke Products Cheap Price - JianXin., 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 Clear Glass Wine Bottle Exporter - Hoyer - 175219(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 | |
Shape Cutting Tools | Shape Cutting Tools OEM/ODM - Millcraft Tools., 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 CE High Quality Apple Wireless Earpods Factories & Manufacturers Pricelist - YIMI., 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 | |
NZ New Zealand Steel Tube Roofing Auckland North Shore - GMZ Roofing., Ltd | HB202001-WH, HN202001 | |
Cheap China Pa Hot Melt Adhesive Granule Factory - 167432., Ltd. | Y195 | |
Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
ZK-BEST (Tow Way Piston Tie Rod Hydraulic Cylinder | Tow Way Piston Tie Rod Hydraulic Cylinder Price - YX-Hydraulic) 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 | |
Hydraulic Welding Cylinder | Hydraulic Welding Cylinder Price - YX-Hydraulic. Ltd. | PGT-0095 | |
ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
Metal Milling Cutter | Metal Milling Cutter Suppliers - Millcraft Tools., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
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Laser Cnc Machine For Sale | Laser Cnc Machine For Sale Factory - Ruijie(Wholesale China Abs Plastic Molding Suppliers - 102350)
6900rs Bearing | 6900rs Bearing Price - HxhWholesale China Chest Tube Exporter - Richeng - 168663. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Supply China Red Wood Chipper OEM/ODM Quotes - Kingoro - 157658'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,Ultra Slim Ethernet Cables | Ultra Slim Ethernet Cables Price - CableCreation.Wholesale Cheap OEM/ODM Concrete Nails Suppliers & Manufacturers Quotes - 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:Blender Sponge Vendor | Blender Sponge Vendor Price - mycolor
Wholesale China Intrauterine Foley Catheter Wholesaler - Richeng - 168663 | Manufacturer | Respirator Model(s)OEM China Cnc Machining Company Wholesaler - 82574 |
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2020-10-26 | AAB (China) Co., Ltd | KN95 |
2020-10-26 | Protective Cnc Laser Cutting Machine | Protective Cnc Laser Cutting Machine Suppliers - Ruijie., 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 | Wholesale Cheap OEM/ODM Safety Footwear Italy Factories & Manufacturers Pricelist - TianXing KeSheng., 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 | OEM China Sterile Face Mask Wholesaler - 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 | Desk Stand Up Sit Down | Desk Stand Up Sit Down Manufacturers - Saosen., 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 OEM Custom Flanged Ball Valve Factories & Manufacturers Pricelist - JKG Valve., Ltd. | Bocai KN95 |
2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
2020-10-26 | Quality Chinese Products | Quality Chinese Products Factory - Anebon. 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 China Ventilator Breathing Circuit OEM/ODM Quotes - Richeng - 168663. 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 |
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Supply OEM Custom Led Wifi Bulb Suppliers & Manufacturers Quotes - LowcledExhibit 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-Supply China Green Tea Weight Loss OEM/ODM Quotes - Liao Cheng - 172990 | 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)Supply China Table Set Factory - Saipu - 175187(see section 564(g)(2)(B)). Under section 564(c) of the Act,Supply China N95 Mask Surgical Wholesaler - Felix - 177695“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,Blender Sponge Vendor | Blender Sponge Vendor Price - mycolor(see section 564(g)(2)(C) of the Act),Cnc Company | Cnc Company OEM/ODM - Anebon.
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