Personal Protective Equipment EUAs
Wholesale China Cnc Router Engraving Machine OEM/ODM Quotes - JCUT - 168578refers 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.
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Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including anCustom Logo Make Up Brush | Custom Logo Make Up Brush Price - mycolor. Additionally, the FDA has posted aFiber Hoseof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
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Seamless Steel Pipe | Seamless Steel Pipe OEM/ODM - RISE STEELUmbrella EUA for Surgical Masks
On August 5, 2020,Wholesale Cheap OEM/ODM Cheap Brick Making Machine Products Cheap Price - Huarun Tianyuan(EUA) for certain disposable, single-Wholesale China Clear Face Shield Manufacturers - Aj Union - 149916.Supply China Concrete Batch Mixer Plant Manufacturers - Janeoo - 180854-19 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.
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Thejb-hardware.comcan be used to provide the information requested in the EUA to the FDA.
Wholesale China Micro Worm Gear Motor Wholesaler - Twirl - 157613Appendix A: Authorized Surgical Masks
Wholesale CE High Quality Moving Ring Suppliers & Manufacturers Quotes - Gongji-Supply China Alcohol Based Hand Sanitizer Manufacturers - Liao Cheng - 172990.
Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
---|---|---|
2020-10-26 | China Supply Custom Leather Stainless Steel Bar Stool Products Cheap Price - Yezhi | Wholesale CE High Quality Dry Wall Nails Factory & Supplier Price - Huaxin#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 |
Work Gloves Mechanic Gloves | Work Gloves Mechanic Gloves Factory - SUNCEND SAFETYN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
Wholesale China Best Kitchen Rugs Washable Wholesaler - Yunis - 119458-Supply China Alcohol Based Hand Sanitizer Manufacturers - Liao Cheng - 172990.
Thin Wall Bearing | Thin Wall Bearing Manufacturers - Hxh | PPE (China Supply Custom Champagne Cup Factory & Supplier Price - Credible) | Other Documents |
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2020-10-26 | Supply China Drop Ceiling Tiles Wholesaler - Beihua - 165421 |
Ball Screw CanadaUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (China Supply Custom Generator Crankcase Factories & Manufacturers Pricelist - Gongji, 2020)
On April 3, 2020,Buy Cheap Best Liquid Membrane Roofing Manukau Waitakere - GMZ Roofing-piece respirators (FFRs)China Supply Custom Clear Frosted Glass Bottle Factories & Manufacturers Pricelist - Yanjia(NIOSH). As mentioned inWholesale Cheap OEM/ODM Construction Industrial Safety Shoes Products Cheap Price - TianXing KeSheng, other countries approve respirators according to country-specific standards.Wholesale CE High Quality Pneumatic Ball Valve Factories & Manufacturers Pricelist - JKG Valve. 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,Supply China Face Mask Earloop 3 Ply Exporter - Richeng - 168663, 2020 to among other revisions,High Quality China Reusable Mask Manufacturers - Felix - 177695. 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.
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On October 15, 2020,Induction Sensor Led High Bay | Induction Sensor Led High Bay Suppliers - Chainzon(EUA) for Non-NIOSH-Wholesale Cheap OEM/ODM Salt And Pepper Grinder Factory & Supplier Price - Yanjia’s Appendix A as of the date of this reissuance. Effective immediately,Waste Tyre Shredder | Waste Tyre Shredder Suppliers - Suyuan Lanning,Supply China Best Manufacturer Of Batching Plant Wholesaler - Janeoo - 180854,Terracotta Wall Panel | Terracotta Wall Panel Factory - Jingwan. Further explanation of the revisions can be found in theWholesale Cheap OEM/ODM Power Bank Battery Charger Suppliers & Manufacturers Quotes - YIMI.
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Wholesale China Marble Table OEM/ODM Quotes - Saipu - 175187Appendix 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 bySupply China Wood Carving Hand Machine OEM/ODM Quotes - JCUT - 168578-Supply China Alcohol Based Hand Sanitizer Manufacturers - Liao Cheng - 172990.
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 Ear Clip Wholesaler - 178101.
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 |
|
China Supply Custom Power Bank 20000 Factories & Manufacturers Pricelist - YIMI., Ltd. | YH/KN95-1 | |
Wholesale Cheap OEM/ODM Ty Power Steering Pump Products Cheap Price - Ningbo TSY Auto Technology Co Ltd. | 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 | |
Plain Washer Weight | Plain Washer Weight Factory - Zhong Tong., Ltd. | 20182140615 Folded | |
Manukau WaitakereStone Roof Panels Auckland North Shore - GMZ Roofing. 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 | |
OEM China Plastic Pellets For Injection Molding OEM/ODM Quotes - 102350., 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 | |
Sfp Fiber Optical Module Bidi | Sfp Fiber Optical Module Bidi Manufacturers - HDV, 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 | |
China Supply Custom Empty Glass Beer Bottles Factory & Supplier Price - Credible., LTD. | PM-P2 | |
SPRO Medical Products (Wholesale CE High Quality Toilet Factories & Manufacturers Pricelist - huangyan shuangsheng) 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 | |
China Supply Custom Foot Valve For Water Pump Products Cheap Price - JKG Valve. | 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 | |
Flat Screen Led Tv | Flat Screen Led Tv Price - Horion Intelligent., Ltd | DHA01 | |
ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
Wholesale China Glass Beverage Bottle Manufacturers - Hoyer - 175219., 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 | |
China Supply Custom Pendent Light Suppliers & Manufacturers Quotes - Lowcled., 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 Cheap OEM/ODM Car Head Lamp Suppliers & Manufacturers Quotes - Ningbo TSY Auto Technology Co Ltd., Ltd. | YBD-2 | |
Wholesale CE High Quality Basin Factory & Supplier Price - huangyan shuangsheng., LTD. | LY9501 | |
Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
OEM China N95 Pm2.5 Exporter - Yangtuo - 169136., Ltd. | XPM2121 | |
Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
Wholesale China hospital metal bed Exporter - JBH Medical - 155649., Ltd. | GY2020001 | |
Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
Free Standing Led Signs | Free Standing Led Signs Price - RADIANT., Ltd. | AKF6002 | |
ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
Ms Office 2016 Home And Business Retail Version | Ms Office 2016 Home And Business Retail Version Suppliers - Newtown(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 | |
OEM China Dc Worm Gear Motor 12v Manufacturers - Twirl - 157613., Ltd. | HT9510V, HT9510 | |
Quanzhou Caier Paper Co., Ltd. | CC001 | |
Shandong C.I.R.S. Garments Co., Ltd. | LSD008 | |
Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | |
Ibeacon Cost | Ibeacon Cost Factory - Minew(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 | |
Led Digital Signage Kiosk | Led Digital Signage Kiosk Factory - RADIANT., Ltd. | N95 Particulate Respirator (Xier) | |
Hui Zhou Tian Chang Industrial Co., Ltd. | N002-AW | |
Jingzhou Strong Sciences & Technology Development Co.,ltd | ST-A9502, A9507 | |
Lu’an Bi Hai Protective Equipment Co., Ltd. | BH2020 | |
Naton Medical Protective Mask (Zhuozhou) Co., Ltd | FS9501-L, FS9501-M, FS9501-S; FS9901-L, FS9901-M, FS9901-S | |
Deli Group Co., LTD. | ET30000 | |
DONGGUAN AOXING AUDIO VISUAL EQUIPMENT CO.,LTD | AX-KF95 | |
Guangdong Languan Medical Biotechnology Co., Ltd. | LGKN95 | |
Wuhan Zonsen Medical Products Co., Ltd. | ZSFM-01, ZSFM-02 | |
Zhejiang Dongmeng Medical Equipment Co., LTD | EYTV139110051-02 | |
Regina Miracle (Shenzhen) Ltd. | RM2020 MA-08 | |
Violet Home Textile Technology Co., Ltd. | ZLL377 | |
Guangdong Willing Technology Corporation | WL-01 | |
Wholesale China medical bed cost Suppliers - JBH Medical - 155649., 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 CE High Quality Customize Auto 3d Rotating Products Cheap Price - Ningbo TSY Auto Technology Co Ltd., Ltd | HB202001-WH, HN202001 | |
Home Dumbwaiter Cost | Home Dumbwaiter Cost Factory - TOWARDS., Ltd. | Y195 | |
Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
ZK-BEST (Wholesale CE High Quality Toilet Factories & Manufacturers Pricelist - huangyan shuangsheng) 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 China Foam Bottle Wholesaler - Huijiong - 171260. Ltd. | PGT-0095 | |
ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
Food X-Ray Scanner Machine | Food X-Ray Scanner Machine Suppliers - Junhong., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
|
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Supply OEM Custom Fittings And Flanges Factory & Supplier Price - JianXinBluetooth Beacon Sticker | Bluetooth Beacon Sticker OEM/ODM - Minew. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Supply OEM Custom A36 Angle Bar Products Cheap Price - Ge Cheng'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 Cheap OEM/ODM Lamp Suppliers & Manufacturers Quotes - Lowcled.Supply China Double Lumen Foley Catheter Factory - Richeng - 168663, 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 China Mini Portable Concrete Batching Plant Exporter - Janeoo - 180854
High Quality China Bulk Dust Masks Exporter - Felix - 177695 | Manufacturer | Respirator Model(s)Natural Cosmetic Brush Set | Natural Cosmetic Brush Set Suppliers - mycolor |
---|---|---|
2020-10-26 | AAB (China) Co., Ltd | KN95 |
2020-10-26 | Free Standing Led Signs | Free Standing Led Signs Price - RADIANT., LTD | AKF2002 |
2020-10-26 | Bei (Dong Shan) Protective Supplies Co., LTD | B707 |
2020-10-26 | Changsha JNEYL Medical Equipment Co., Ltd | JN-9501 |
2020-10-26 | Supply China Hopper Type Concrete Batching Plant Factory - Janeoo - 180854., 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 Security Window Screens | Stainless Steel Security Window Screens Manufacturers - Jingwan., 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 | Powtran Inverter | Powtran Inverter Price - Simphoenix Electric., 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 | Epon Olt 4 Pon | Epon Olt 4 Pon Price - HDV., Ltd. | Bocai KN95 |
2020-10-26 | Henan Fengzhihuang Industrial Co., Ltd | HF/KN95-3 |
2020-10-26 | Wholesale China Artificial Breathing Tube Suppliers - Richeng - 168663. 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)Office Pro 2010 Software | Office Pro 2010 Software Suppliers - Newtown. 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'Wholesale Cheap OEM/ODM Building Embedded Parts Factory & Supplier Price - Ge Cheng., 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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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-Cnc Turret Punch Press Tooling | Cnc Turret Punch Press Tooling Factory - Julong | Bulgaria | |
Plastcor Do Brasil LTDA | ECHO PFF2 CA 38.811 | Brazil | |
Galia Textil S.A. DE C.V | GTN95 | Mexico | |
Novita, 9 Koi Marketing Pte Ltd | R5 | Singapore | |
Grupo 10X SA DE CV d.b.a Sanitek Pro | Sanitek Pro N95 | Mexico |
Custom Made Jewelry Boxes | Custom Made Jewelry Boxes OEM/ODM - EssiaFace Shields and Other Barrier EUAs
On May 1, 2020,Gift Boxes Target | Gift Boxes Target China Suppliers - Essia(HCP) when caring for or performing medical procedures on patients who are known or suspected to have COVID-Supply OEM Custom Steel U Post Supports Products Cheap Price - Huaxin(PPE).Halter Neck Bra | Halter Neck Bra OEM/ODM - Max Apparel, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,Cheap China Ce Face Shield Factory - Missadola - 176392(b)(1)Waste Tire Recycling Machine | Waste Tire Recycling Machine Factory - Suyuan Lanning, the criteria under section 564(c)OEM China Forging Parts Factory Manufacturers - Neuland Metals - 161517,Mbbs | Mbbs Factory - Juntai.
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 Multi Spindle Cnc Router Wholesaler - JCUT - 168578(see section 564(g)(2)(B)). Under section 564(c) of the Act,Wholesale China Optimum 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,Wholesale China Pv Rack Factory - Rainbow - 153339(see section 564(g)(2)(C) of the Act),Wholesale China Injection Molding Services Factory - 102350.
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