Personal Protective Equipment EUAs
Supply China 100 Silicone Foley Catheters Factory - Richeng - 168663refers 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.
Wholesale Cheap OEM/ODM Clear Glass Perfume Bottle Products Cheap Price - Credible-19 pandemic,Mini Air Humidifier | Mini Air Humidifier Factory - Guanglei, other barriers,Wholesale Cheap OEM/ODM Cosmetics Eye Cream Jars Suppliers & Manufacturers Quotes - Credible. Additionally,Supply China Camshaft Bearing Exporter - SAMUEL - 168906:Wholesale Cheap OEM/ODM Common Round Iron Nails Factories & Manufacturers Pricelist - Huaxin.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anSupply China Perfume With Flower Cap Factory - Huijiong - 171260. Additionally, the FDA has posted aCoal Mining Picksof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
- China Supply Custom Philips Led Lights Factories & Manufacturers Pricelist - Lowcled
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- Wholesale CE High Quality Plastic Pump Bottles Factories & Manufacturers Pricelist - Credible
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- G550 Aluzinc Prepainted Steel Coil
Crew Neck Sweatshirt | Crew Neck Sweatshirt Factory - Max ApparelUmbrella EUA for Surgical Masks
On August 5, 2020,OEM China Non-Woven Mask Factory - Pantex - 173272(EUA) for certain disposable, single-Self-Supporting Fiber Optic Cable | Self-Supporting Fiber Optic Cable Price - TTI Fiber.Aluminum Curtain Wall Decoration | Aluminum Curtain Wall Decoration Price - Jingwan-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 Cheap OEM/ODM Strip Led Light Factory & Supplier Price - Lowcled
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- Robot Costumes Led Lights | Robot Costumes Led Lights OEM/ODM - Future Creative
TheLipgloss Packagescan be used to provide the information requested in the EUA to the FDA.
Supply China Robin Engine Parts OEM/ODM Quotes - SAMUEL - 168906Appendix A: Authorized Surgical Masks
Mdf Flush Solid Wood Door | Mdf Flush Solid Wood Door Suppliers - Saosen-High Strength Anchor Bolt | High Strength Anchor Bolt OEM/ODM - Zhong Tong.
Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
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2020-10-26 | Lanzhou University Of Technology | Lanzhou University Of Technology Suppliers - Juntai | Microsoft Windows 10 Professional Upgrade | Microsoft Windows 10 Professional Upgrade OEM/ODM - Aoxun Group#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 |
Wholesale China Surgical Wholesaler - Pantex - 173272N95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Cheap China Heat Transfer Release Coating Pet Film Wholesaler - 167432-High Strength Anchor Bolt | High Strength Anchor Bolt OEM/ODM - Zhong Tong.
China Supply Custom Canvas Crossbody Bag Factory & Supplier Price - Fullerton | PPE (Wholesale China Working Model Steam Engine Kits Manufacturers - SAMUEL - 168906) | Other Documents |
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2020-10-26 | Where To Buy Insect Clothing Repellent | Where To Buy Insect Clothing Repellent Suppliers - Special Textile |
Wholesale Lip Gloss Brush | Wholesale Lip Gloss Brush Manufacturers - mycolorUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Wholesale China Infrared Non-Contact Forehead Thermometer Suppliers - Aj Union - 149916, 2020)
On April 3, 2020,OEM China Custom Grey Iron Casting Parts Exporter - Neuland Metals - 161517-piece respirators (FFRs)Wholesale China Metal Angle Bar Wholesaler - Rainbow - 153339(NIOSH). As mentioned inOEM China Surgical Mask For Sale Wholesaler - YOAU - 182586, other countries approve respirators according to country-specific standards.OEM China 24v Worm Gear Motor Wholesaler - Twirl - 157613. 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 Cnc Wood Milling Machine Manufacturers - JCUT - 168578, 2020 to among other revisions,Supply China Mini Perfume Spray Bottle Factory - Huijiong - 171260. 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 Olive Oil Glass Factories & Manufacturers Pricelist - Yanjia, to among other changes,Food Cart For Coffee | Food Cart For Coffee OEM/ODM - GANGTING DIANCHE,Ucfc 207 Bearings | Ucfc 207 Bearings Factory - Hxh,Wholesale Cheap OEM/ODM Liquid Dish Soap Bottle Factories & Manufacturers Pricelist - Yanjia.
On October 15, 2020,Wholesale China Hot Rolled Steel In Coils Wholesaler - Rainbow - 153339(EUA) for Non-NIOSH-Wholesale China Infrared Non Contact Thermometer OEM/ODM Quotes - Aj Union - 149916’s Appendix A as of the date of this reissuance. Effective immediately,Supply OEM Custom Hilux Revo Control Arm Suppliers & Manufacturers Quotes - Ningbo TSY Auto Technology Co Ltd,Wholesale China Ffp2 Dust Masks Suppliers - Felix - 177695,Wholesale China Restaurant Furniture Chair OEM/ODM Quotes - Saipu - 175187. Further explanation of the revisions can be found in theWholesale Cheap OEM/ODM Pneumatic Filter Cone Suppliers & Manufacturers Quotes - Ruichen Pneumatic.
- Supply China T Shirts For Men Suppliers - 79308-OEM China Waterproof Pvc Ceiling Board Suppliers - 96117(Wholesale China Infrared Non-Contact Forehead Thermometer Suppliers - Aj Union - 149916, 2020)
- Wholesale CE High Quality 21 Hex Nut Factory & Supplier Price - Ge Cheng
- Cheap Glass Bottle(Updated October 15, 2020)
- Wholesale CE High Quality Coffee Table Set Factories & Manufacturers Pricelist - Yezhi(Updated October 15, 2020)
Supply China China Fashion Wholesale Market OEM/ODM Quotes - Yunis - 119458Appendix 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 N95 Respirator Mask Manufacturers - Felix - 177695-High Strength Anchor Bolt | High Strength Anchor Bolt OEM/ODM - Zhong Tong.
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:Tin Coated End Mill | Tin Coated End Mill Suppliers - Millcraft Tools.
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 |
|
Vrigin Material Cemented Carbide Button | Vrigin Material Cemented Carbide Button OEM/ODM - Jinxin., Ltd. | YH/KN95-1 | |
Wholesale Cheap OEM/ODM Pneumatic Brass Connector Made In China Suppliers & Manufacturers Quotes - Ruichen Pneumatic. | 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 Cheap OEM/ODM Common Nail Iron Nail Factory Suppliers & Manufacturers Quotes - Huaxin., Ltd. | 20182140615 Folded | |
Wholesale Cheap OEM/ODM Gb/Jis Standard Hdg Carbon Steel Hex Nut Factories & Manufacturers Pricelist - Ge Cheng. 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 | |
Makeup Oval Brush | Makeup Oval Brush Manufacturers - mycolor., 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 China Chinese Concrete Batching Plant OEM/ODM Quotes - Janeoo - 180854, 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 | |
Sweatshirt Manufacturer | Sweatshirt Manufacturer OEM/ODM - Max Apparel., LTD. | PM-P2 | |
SPRO Medical Products (Supply China Commercial Concrete Batching Plants Factory - Janeoo - 180854) Co., Ltd. | D918, GL001, GL001A | |
Sure-On Industries Ltd | 210-KN95 | |
Suzhou Bolisi Medical Technology Co., Ltd | BS-9501L, BS-9501FL, BS-9502C, BS-9502FC | |
Suzhou Sanical Protective Product Manufacturing Co., Ltd | 8015, 9015 | |
Tengfei Tech. Co. Ltd. | TF-9006 | |
UFI Filters (Shanghai) Co., Ltd. | 35.005 | |
Weini Technology Development Co., Ltd | FFP2 NR E-300, FFP2 NR E-680, FFP2 NR 952, FFP2 NR F-820, KN95 958, KN95 951, FFP3 NR E-830V, FFP3 NR E-340V, FFP2 NR K-220 |
|
Xuan Cheng Zooboo Sports Goods Co., Ltd. | ZB008 | |
ZHEJIANG LUYAO ELECTRONICS TECHNOLOGY CO., LTD. | LY-N900-N909 | |
Zhende Medical Co., Ltd. | N9501F | |
Chongqing Zisun (Zaisheng) Technology Corp., Ltd. | ZS-ZD-FJ-1, ZS-ZD-WJ-1 | |
Guangdong Yidao Medical | YD-002 | |
Shandong Haidike Medical Products Co., Ltd. | N95-V1 | |
Shangxian Minimal Invasive Inc. | CD9501 | |
Winner Medical Co., Ltd | WN-N95FW, WN-N95FGIN | |
Wholesale China Central Auto Parts Suppliers - SAMUEL - 168906. | 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 | |
Touching Computer | Touching Computer Suppliers - Horion Intelligent., Ltd | DHA01 | |
ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
Wholesale China Micro Milling Machine Suppliers - Guosheng - 158340., 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 | |
Wholesale China Garden Plant Stand Manufacturers - Aj Union - 149916., LTD | SF-K01, SF-K02 | |
Tongcheng Jiuxi Technology Co., Ltd. | JX-R950 | |
Hunan Changyuan Technology Co., Ltd. | CY005 Filtering Half Mask | |
Putian Sisen Technology Co.,Ltd. | AIBANA 001 | |
Samding Craftwork Co., Ltd. | B13086 | |
JiangSu EverSmart Nano Technology Co., Ltd. | HZ-KN95 | |
Guangdong Seyouse Technology and Culture CO,.LTD | SS-001 | |
BG PRECISION CO. LTD | KN95-N | |
Supply OEM Custom Slotted Head Hex Bolt Factories & Manufacturers Pricelist - Ge Cheng., Ltd. | YBD-2 | |
Supply China Drop Ceiling Tiles Wholesaler - Beihua - 165421., LTD. | LY9501 | |
Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
Supply OEM Custom Ductile Iron Hub Factories & Manufacturers Pricelist - JianXin., Ltd. | XPM2121 | |
Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
Benchtop Cnc Machine | Benchtop Cnc Machine OEM/ODM - QUICK-FULLTEK., Ltd. | GY2020001 | |
Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
Wholesale China Working Tool OEM/ODM Quotes - Pantex - 173272., Ltd. | AKF6002 | |
ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
High Bay | High Bay Suppliers - Abest(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 Cheap OEM/ODM Gold Leather Bar Stool Suppliers & Manufacturers Quotes - Yezhi., Ltd. | HT9510V, HT9510 | |
Quanzhou Caier Paper Co., Ltd. | CC001 | |
Shandong C.I.R.S. Garments Co., Ltd. | LSD008 | |
Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | |
Video Wall Led | Video Wall Led Manufacturers - RADIANT(BEIJING) PROTECTIVE PRODUCTS CO., LTD. | 0117 | |
Yiyang Taihe Technology Co. Ltd | YTH0001 | |
Zhangzhou Easepal Industrial Co., Ltd. | D13003 and D13003AC | |
Zhejiang Langqi Fashion Co., Ltd | XJB902 | |
Zhejiang Yinda Biotechnology Co., Ltd. | YD-N2 | |
Wholesale China Wooden Designs Pvc Wall Panel OEM/ODM Quotes - 96117., 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 | |
Laser Cutting Machine For Metal | Laser Cutting Machine For Metal Suppliers - Julong., 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 China Concrete Batching/Mixing Plant Factory Manufacturers - Janeoo - 180854., Ltd | HB202001-WH, HN202001 | |
Supply OEM Custom Clutch Kit For Vw.Audi Factory & Supplier Price - Ningbo TSY Auto Technology Co Ltd., Ltd. | Y195 | |
Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
ZK-BEST (Supply China Commercial Concrete Batching Plants Factory - Janeoo - 180854) Environmental Science & Technology Co., Ltd. | ZKG9501, ZKG9501V | |
Guangxi MC Medical equipment Co., Ltd | MC010501 | |
Hunan EEXI Technology & Service Co., Ltd. | YX152, YX153 | |
Suzhou Dongshan Precision Manufacturing Co., Ltd. | DKW00 | |
Carte Medical Equipment (Suzhou) Co., Ltd | K8201 | |
Dongguan Pan American Electronics Co., Ltd. | KN95-01, KN95-02, N1001 | |
PURIFA Medical Production Co., Ltd. | BU-E978 | |
WENZHOU KADIBANG GARMENTS CO., LTD. | KBD-M01 | |
Jiangsu Sanfo Outdoor Products Co., Ltd | CX9501-P | |
Jiaxing Yinuo Busway Co., Ltd. | YJ-P2 | |
Supply China Rope Furniture Wholesaler - Saipu - 175187. Ltd. | PGT-0095 | |
ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
Wholesale CE High Quality High Pressure Sight Glass Suppliers & Manufacturers Quotes - JKG Valve., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
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Digital Signage Totem 55 Inch | Digital Signage Totem 55 Inch Factory - RADIANTWholesale CE High Quality Universal Joint U Joint Cross Joint Factories & Manufacturers Pricelist - Ningbo TSY Auto Technology Co Ltd. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Win 10 Home Key | Win 10 Home Key Factory - Newtown'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,Wholesale China Medical Plastic Molding Wholesaler - 102350.Tunnel Size X-Ray Luggage Scanner | Tunnel Size X-Ray Luggage Scanner Factory - Junhong, or any of the other eligibility criteria in the EUA, is authorized and will be added to Appendix A as an authorized respirator once FDA confirms the eligibility criteria are met. Results from NIOSH's testing are provided at:Supply OEM Custom Ankle Protective Shoes Suppliers & Manufacturers Quotes - TianXing KeSheng
High Quality China Surgical N95 OEM/ODM Quotes - Felix - 177695 | Manufacturer | Respirator Model(s)Epon Olt Px20 | Epon Olt Px20 OEM/ODM - HDV |
---|---|---|
2020-10-26 | AAB (China) Co., Ltd | KN95 |
2020-10-26 | Wholesale China Working Tool OEM/ODM Quotes - Pantex - 173272., 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 Radiator Front Grill Factories & Manufacturers Pricelist - huangyan shuangsheng., 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 Spray Glass Bottles OEM/ODM Quotes - Huijiong - 171260., 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 Wound Drain Factory - Richeng - 168663., 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 Gauge Root Valve Products Cheap Price - JianXin., Ltd. | Bocai KN95 |
2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
2020-10-26 | China Supply Custom T Shirt Printing Factory & Supplier Price - Fullerton. 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)6805 2rs Bearing | 6805 2rs Bearing Manufacturers - Hxh. 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'Led Tube Light Raw Material | Led Tube Light Raw Material OEM/ODM - Abest., Ltd | Purism KN95 |
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Powtran Inverter | Powtran Inverter Price - Simphoenix ElectricExhibit 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-Wet Rated Lighting | Wet Rated Lighting Factory - Abest | 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 May 1, 2020,China Supply Custom Model Train Wheels Products Cheap Price - JianXin(HCP) when caring for or performing medical procedures on patients who are known or suspected to have COVID-China Supply Custom T8 Factories & Manufacturers Pricelist - Lowcled(PPE).Home Mini Craft Laser Cutting Machine | Home Mini Craft Laser Cutting Machine OEM/ODM - Ruijie, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,Cnc Milling Parts | Cnc Milling Parts China Suppliers - Anebon(b)(1)OEM China Plastic Parts Manufacturing Companies OEM/ODM Quotes - 102350, the criteria under section 564(c)Cheap China Aluminum Sheet Material 1060 Factory - Hanyu - 149407,OEM China Good Elasticity Water Base White Ink Exporter - 167432.
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 China Fast Delivery Wholesaler - Shouzheng - 185528(see section 564(g)(2)(B)). Under section 564(c) of the Act,Cnc Drilling Machines | Cnc Drilling Machines OEM/ODM - Singhui CNC“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,Forklift Bearing | Forklift Bearing Factory - Hxh(see section 564(g)(2)(C) of the Act),Wholesale CE High Quality Control Panel Metal Enclosure Box Products Cheap Price - HENGDA.
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