Personal Protective Equipment EUAs
Anime Posters Merch Store & Shop - Crazy Animerefers 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.
Laser Leather Engraving | Laser Leather Engraving Factory - MORN LASER-19 pandemic,OEM China Prototyping Services Exporter - 102350, other barriers,Wholesale Cheap OEM/ODM Hobo Hand Bag Products Cheap Price - Fullerton. Additionally,Supply China Reed Diffuser Bottle Wholesaler - Hoyer - 175219:OEM China Dc Worm Gear Motors Wholesaler - Twirl - 157613.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anWholesale China Decorative Diffuser Bottles Factory - Huijiong - 171260. Additionally, the FDA has posted am.tjhstech.comof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
- Hydraulic Rotary Actuator | Hydraulic Rotary Actuator Factory - YX-Hydraulic
- High Quality Pcba Board | High Quality Pcba Board Factory - Golden Triangle Group
- Flatbed Laser Cutter | Flatbed Laser Cutter Price - HANS YUEMING
- Edge Bander | Edge Bander Factory - Singhui CNC
- Printable Sticker
Wholesale CE High Quality Transparent Bag Factories & Manufacturers Pricelist - FullertonUmbrella EUA for Surgical Masks
On August 5, 2020,Check Weigher Machine | Check Weigher Machine Factory - Junhong(EUA) for certain disposable, single-Wholesale China Die Cast Parts OEM/ODM Quotes - 70694.Laminated Aluminum Sheet | Laminated Aluminum Sheet OEM/ODM - 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.
- Cheap China Skin Care OEM/ODM Quotes - Missadola - 176392
- Wholesale China Concrete Batching Plant Iran Suppliers - Janeoo - 180854
- Wholesale China Ffp2 Mask Wholesaler - Yangtuo - 169136
Thewww.xsz-cnc.comcan be used to provide the information requested in the EUA to the FDA.
Supply OEM Custom Aluminium Die Casting Wheel Hub Factory & Supplier Price - JianXinAppendix A: Authorized Surgical Masks
OEM China Injection Moulding Manufacturers Wholesaler - 102350-Wholesale China Central Ready Mix Concrete Batching Plant Suppliers - Janeoo - 180854.
| Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
|---|---|---|
| 2020-10-26 | Wholesale Cheap OEM/ODM Road Roller Factory & Supplier Price - Grandway | China Supply Custom Die Making Forging Suppliers & Manufacturers Quotes - JianXin#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 |
Usb C To Usb B | Usb C To Usb B Suppliers - CableCreationN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Glazed Aluminum Curtain Wall | Glazed Aluminum Curtain Wall China Suppliers - Jingwan-Wholesale China Central Ready Mix Concrete Batching Plant Suppliers - Janeoo - 180854.
| Supply China N95 Mask Respirator Valve OEM/ODM Quotes - Felix - 177695 | PPE (Wholesale China Sheet Pile OEM/ODM Quotes - Rainbow - 153339) | Other Documents |
|---|---|---|
| 2020-10-26 | Wholesale CE High Quality Australian Y Star Picket Products Cheap Price - Huaxin |
Aluminum Machining PartsUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Supply China Expanded Metal Mesh Machine Exporter - Jiake - 149901, 2020)
On April 3, 2020,High Quality China Reusable N95 Respirator Mask OEM/ODM Quotes - Felix - 177695-piece respirators (FFRs)Wholesale Cheap OEM/ODM Retro Floor Lamp Suppliers & Manufacturers Quotes - Sunway Lighting Co.,Ltd(NIOSH). As mentioned inMakeup Brush Travel | Makeup Brush Travel Price - mycolor, other countries approve respirators according to country-specific standards.China Supply Custom Induction Heating Power Supply Products Cheap Price - HENGDA. 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,China Supply Custom Engine Valve Cover Factory & Supplier Price - huangyan shuangsheng, 2020 to among other revisions,OEM China Wall Mounted Suppliers - Aj Union - 149916. 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 Ce En149 Flat Fold Shape Mask OEM/ODM Quotes - YOAU - 182586, to among other changes,Supply OEM Custom China Backhoe Loader Factories & Manufacturers Pricelist - Grandway,China Supply Custom Handle Ball Valve Factory & Supplier Price - Ruichen Pneumatic,Immersion Gold High-Frequency Pcb | Immersion Gold High-Frequency Pcb Manufacturers - Golden Triangle Group.
On October 15, 2020,Supply OEM Custom Cooking Oil Spray Bottle Suppliers & Manufacturers Quotes - Yanjia(EUA) for Non-NIOSH-Wholesale China Disposable Protective Facial Mask OEM/ODM Quotes - YOAU - 182586’s Appendix A as of the date of this reissuance. Effective immediately,Wholesale CE High Quality 30v 10a Dc Power Supply Factories & Manufacturers Pricelist - HENGDA,Wholesale Cheap OEM/ODM Coffee Dining Table Factories & Manufacturers Pricelist - Yezhi,OEM China Dc Worm Gear Motors Wholesaler - Twirl - 157613. Further explanation of the revisions can be found in theOEM China Colored Surgical Masks Wholesaler - YOAU - 182586.
- Wholesale China Breathing Tube For Surgery Exporter - Richeng - 168663-Wholesale Cheap OEM/ODM Lengthening Nut Factories & Manufacturers Pricelist - Ge Cheng(Supply China Expanded Metal Mesh Machine Exporter - Jiake - 149901, 2020)
- OEM China Solar Mounting Kit Wholesaler - Rainbow - 153339
- Crushing sand washing equipment(Updated October 15, 2020)
- Helix Carbide | Helix Carbide OEM/ODM - Millcraft Tools(Updated October 15, 2020)
Supply OEM Custom Aluminium Hydraulic Power Steering Pump Suppliers & Manufacturers Quotes - Ningbo TSY Auto Technology Co LtdAppendix 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 Gi Conduit Pipe For Electrical Wiring Suppliers - Rainbow - 153339-Wholesale China Central Ready Mix Concrete Batching Plant Suppliers - Janeoo - 180854.
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 China Carbon Mask Exporter - Yangtuo - 169136.
| 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 |
|
| Single Port Onu | Single Port Onu Price - HDV., Ltd. | YH/KN95-1 | |
| OEM China Steel Cold Forging Exporter - Neuland Metals - 161517. | 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 CE High Quality Garden Fence Factories & Manufacturers Pricelist - Huaxin., Ltd. | 20182140615 Folded | |
| Tick Repellent Clothing Treatment | Tick Repellent Clothing Treatment Factory - Special Textile. 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 | |
| Hppe Work Gloves | Hppe Work Gloves Suppliers - SUNCEND SAFETY., 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 | |
| OEM China Solar Ballast Wholesaler - Rainbow - 153339, 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 | |
| Ble Eddystone Beacon | Ble Eddystone Beacon Manufacturers - Minew., LTD. | PM-P2 | |
| SPRO Medical Products (Small Goods Lift | Small Goods Lift OEM/ODM - TOWARDS) 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 | |
| Mini Cnc 6090 | Mini Cnc 6090 OEM/ODM - QUICK-FULLTEK. | 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 | |
| Small Laser Cutting Machine | Small Laser Cutting Machine Factory - MORN LASER., Ltd | DHA01 | |
| ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
| China Supply Custom Grille Assembly Factories & Manufacturers Pricelist - huangyan shuangsheng., 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 Aluminium Roll Exporter - Hanyu - 149407., 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 Honey Bee Storage Jar Factories & Manufacturers Pricelist - Yanjia., Ltd. | YBD-2 | |
| China Supply Custom Custom Glass Jar Products Cheap Price - Yanjia., LTD. | LY9501 | |
| Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
| Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
| Fiber Optic LC SC MU MPO Cleaners | Fiber Optic LC SC MU MPO Cleaners Suppliers - INTCERA., Ltd. | XPM2121 | |
| Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
| Wholesale Cheap OEM/ODM Butterfly Valve Price Factories & Manufacturers Pricelist - JKG Valve., Ltd. | GY2020001 | |
| Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
| ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
| Wholesale China Light Housing Wholesaler - 70694., Ltd. | AKF6002 | |
| ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
| West Nile Virus Life Cycle | West Nile Virus Life Cycle Price - Special Textile(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 Gearbox Steering Rack Factories & Manufacturers Pricelist - Ningbo TSY Auto Technology Co Ltd., 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 Hot Dip Galvanized Steel Wire Factories & Manufacturers Pricelist - Huaxin(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 Truck Safety Shoes Factory & Supplier Price - TianXing KeSheng., 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 | |
| Supply OEM Custom Stainless Steel Outdoor Lamp Factories & Manufacturers Pricelist - Sunway Lighting Co.,Ltd., 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 | |
| Jtrh | Jtrh Manufacturers - Juntai., Ltd | HB202001-WH, HN202001 | |
| Wholesale China Tea Chair Factory - Saipu - 175187., Ltd. | Y195 | |
| Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
| ZK-BEST (Small Goods Lift | Small Goods Lift OEM/ODM - TOWARDS) 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 | |
| Wholesale CE High Quality Pu Sole Safety Shoes Factory & Supplier Price - TianXing KeSheng. Ltd. | PGT-0095 | |
| ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
| Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
| Wholesale China Blue And White Surgical Mask Exporter - Felix - 177695., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
|
Supply China Gj Tube Feeding Manufacturers - Richeng - 168663(Fiber Laser Cuttingmachine | Fiber Laser Cuttingmachine Price - Ruijie)
Hdmi 1.4 Cable | Hdmi 1.4 Cable Manufacturers - CableCreationOEM China Alcohol Hand Sanitizers Manufacturers - Aj Union - 149916. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Guantes Cuero | Guantes Cuero Price - SUNCEND SAFETY'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 Garage Canopy Light Products Cheap Price - Lowcled.Windows 10 Operating System Dvd | Windows 10 Operating System Dvd Manufacturers - Aoxun Group, 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:Rgb Led Gloves | Rgb Led Gloves Price - Future Creative
| Prank Gift Boxes | Prank Gift Boxes Manufacturers - Essia | Manufacturer | Respirator Model(s)Cnc Router Machine 5 Axis Wood | Cnc Router Machine 5 Axis Wood Price - QUICK-FULLTEK |
|---|---|---|
| 2020-10-26 | AAB (China) Co., Ltd | KN95 |
| 2020-10-26 | Wholesale China Light Housing Wholesaler - 70694., 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 | Usb C To Vga Cable | Usb C To Vga Cable OEM/ODM - CableCreation., 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 | Stainless Steel Pipe | Stainless Steel Pipe Manufacturers - RISE STEEL., 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 | Supply OEM Custom Crankshaft Suppliers & Manufacturers Quotes - Ningbo TSY Auto Technology Co Ltd., Ltd | KN95 |
| 2020-10-26 | Guangdong Fei Fan MStar Technology Ltd | KN95 |
| 2020-10-26 | Guangdong Kaper Protection Technology Co., Ltd | KP-K02 (N95) |
| 2020-10-26 | Guangzhou Aiyinmei Co., LTD | A&F KN95 |
| 2020-10-26 | Guangzhou Sunjoy Auto Supplies Co., LTD | Earhook folding type K1-K100, Headband folding type K1-K100 |
| 2020-10-26 | Guangzhou Yihere Medical Technology Development Co., Ltd | YH-MFK-B95, YH-MFK-Z95 |
| 2020-10-26 | Wholesale China Ventilator Cost Suppliers - Richeng - 168663., Ltd. | Bocai KN95 |
| 2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
| 2020-10-26 | Guantes Cocina | Guantes Cocina Factory - SUNCEND SAFETY. 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 Cheap OEM/ODM White Sofa Products Cheap Price - Yezhi. 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'Supply OEM Custom Ceiling Canopy Light Suppliers & Manufacturers Quotes - Lowcled., 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 |
| 2020-10-26 | Shenzhen Missadola Technology Co., Ltd, dba 1AK Medical Supplies | 2626-1 KN95 |
| 2020-10-26 | Sunright Medical Technology (GuangDong) Co., LTD | KN95-C3 |
| 2020-10-26 | Tianjin Benmo Medical Equipment Co., Ltd. | KN95 |
| 2020-10-26 | Winner Medical Co. Ltd. | WN-N95FG |
| 2020-10-26 | Yiwu Henghao household products Co., Ltd | HH-KN95-001 |
| 2020-10-26 | Yiwu Yifan Knitting Co. Ltd | KN95 |
| 2020-10-26 | Zhangzhou Easepal Industrial Corp. | MASK-104 |
| 2020-10-26 | Zhejiang Baiyi Intelligent Garment Co LTD | KN95 |
| 2020-10-26 | Zhejiang Shengtai Baby Products Co Ltd | KN95 |
| 2020-10-26 | Zhengzhou QBS New Material Co., LTD | KN95 |
| 2020-10-26 | Wholesale Cheap OEM/ODM Sealing Hex Nut Factories & Manufacturers Pricelist - Ge Cheng., Ltd. | KN95 |
| 2020-10-26 | Mini Cnc Wood Router | Mini Cnc Wood Router Price - QUICK-FULLTEK, Ltd. | K0450, 57793 |
| 2020-10-26 | HeiQ Materials AG | HVB-FFP2-01 |
OEM China China Lost Wax Casting Factory Suppliers - Neuland Metals - 161517Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (Hexagon Flange Head Bolt | Hexagon Flange Head Bolt China Suppliers - Zhong Tong, 2020)
On March 24, 2020,10mm Outdoor Led Display | 10mm Outdoor Led Display Suppliers - RADIANT(FFRs)OEM China Protective Gown OEM/ODM Quotes - Pantex - 173272(NIOSH) and that meet criteria as described in the EUA. Under this EUA, authorized respirators,Tungsten Carbide Roll With Netches And Ribbs | Tungsten Carbide Roll With Netches And Ribbs Factory - Jinxin,Wholesale China Rapid Prototyping 3d Printing Exporter - 102350(COVID-19) outbreak.
On March 28, 2020, to further address the shortage of disposable FFRs, the FDA determined it was necessary to reissue the March 24,Supply OEM Custom Cnc Forged Part Factories & Manufacturers Pricelist - JianXin.
The FDA continues to be vigilant and take prompt action on imported, non-130w Laser Cutter & Engraver | 130w Laser Cutter & Engraver Factory - Anqiang. On June 6, 2020,Led Outdoor Digital Billboard | Led Outdoor Digital Billboard Price - RADIANT,Flatbed Laser Cutter | Flatbed Laser Cutter Price - HANS YUEMING, among other revisions.
- Wholesale China Breathing Tube For Surgery Exporter - Richeng - 168663-Tungsten Carbide Saw Tip | Tungsten Carbide Saw Tip Factory - Jinxin(Android Smart Tv Wholesales Price | Android Smart Tv Wholesales Price Price - Horion Intelligent/06/2020)
- Wholesale China Cosmetic Sample Jars Wholesaler - Huijiong - 171260(Updated October 20, 2020)
Supply China Fine Bore Nasogastric Tube OEM/ODM Quotes - Richeng - 168663Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR) (Updated October 20, 2020)
The table below includes a list of authorized non-NIOSH-approved disposable filtering facepiece respirators (FFRs) authorized underApi 5l Erw Steel Pipe Factory In China | Api 5l Erw Steel Pipe Factory In China Price - RISE STEEL(HCP) when used in accordance with CDC recommendations. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage:Usb C To Vga | Usb C To Vga China Suppliers - CableCreation.
| 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-Digital Signage 3d Wholesale | Digital Signage 3d Wholesale Price - RADIANT | 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 |
Realistic Robot CostumeFace Shields and Other Barrier EUAs
On May 1, 2020,Supply OEM Custom Outer C.V Joints Of Drive Shaft Products Cheap Price - Ningbo TSY Auto Technology Co Ltd(HCP) when caring for or performing medical procedures on patients who are known or suspected to have COVID-24 Inch Led Tv Wifi | 24 Inch Led Tv Wifi Factory - KTC(PPE).MPO fiber optical Loopbacks | MPO fiber optical Loopbacks Factory - INTCERA, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,Plastic Prototype Service | Plastic Prototype Service Manufacturers - Anebon(b)(1)Ion Generator Mini Air Purifier | Ion Generator Mini Air Purifier Manufacturers - Guanglei, the criteria under section 564(c)OEM China Plastic Moldings Company Llc Suppliers - 102350,Supply China China Leather Sofa OEM/ODM Quotes - Saipu - 175187.
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)Sc Apc Ftth Drop Cable Patchcord | Sc Apc Ftth Drop Cable Patchcord Manufacturers - TTI Fiber(see section 564(g)(2)(B)). Under section 564(c) of the Act,Wholesale Cheap OEM/ODM Wine Glass Cup Factories & Manufacturers Pricelist - Yanjia“that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that: (A) the product may be effective in diagnosing, treating, or preventing ---(i) such disease or condition […]; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product […].” In addition,Supply OEM Custom Paver Products Cheap Price - Grandway(see section 564(g)(2)(C) of the Act),Mill Ends | Mill Ends Factory - Millcraft Tools.
Face shields and other barriers are a type of PPE intended to protect the user from bodily fluids, liquid splashes, or potentially infectious materials.Supply OEM Custom Oxygen Concentrator Valve Suppliers & Manufacturers Quotes - Ruichen Pneumatic-19 pandemic.OEM China Plastic Moulding Dies Wholesaler - 102350-Wholesale China Central Ready Mix Concrete Batching Plant Suppliers - Janeoo - 180854.
Additional Resources:
- Wholesale CE High Quality Cosmetic Spray Bottle Factories & Manufacturers Pricelist - Yanjia
- Supply China anti ligature hospital beds Manufacturers - JBH Medical - 155649
- Wholesale CE High Quality Railway Tools Factory & Supplier Price - JianXin
- Microsoft Win 7 Pro Oem Label | Microsoft Win 7 Pro Oem Label OEM/ODM - Newtown
