Personal Protective Equipment EUAs
Wholesale CE High Quality Roofing Screw Products Cheap Price - Huaxinrefers 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 anChina Supply Custom Waterproof Led Light Suppliers & Manufacturers Quotes - Lowcled. Additionally, the FDA has posted aSupply OEM Custom Forged Plate Flange Factory & Supplier Price - JianXinof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
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Wholesale China Latex Free Foley Tube Manufacturers - Richeng - 168663Umbrella EUA for Surgical Masks
On August 5, 2020,Wholesale CE High Quality Construction Accessories Factory & Supplier Price - JianXin(EUA) for certain disposable, single-Wholesale China Solar Panel Side Of Pole Mount Manufacturers - Rainbow - 153339.OEM China Surgical Gowns Big Men Factory - Missadola - 176392-19 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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TheSupply China Chair Factory - Saipu - 175187can be used to provide the information requested in the EUA to the FDA.
Wholesale China Tea Chair Factory - Saipu - 175187Appendix A: Authorized Surgical Masks
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Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
---|---|---|
2020-10-26 | OEM China Injection Moulding Business For Sale OEM/ODM Quotes - 102350 | Wholesale China Silicone Urethral Catheter Exporter - Richeng - 168663#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 Cheap OEM/ODM Cafe Table Products Cheap Price - YezhiN95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
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Makeup Sponge Manuyfacturer | Makeup Sponge Manuyfacturer Factory - mycolor | PPE (Vatop Windows Tablet Pc | Vatop Windows Tablet Pc OEM/ODM - Newtown) | Other Documents |
---|---|---|
2020-10-26 | Cnc Wood Drilling Machine | Cnc Wood Drilling Machine Manufacturers - QUICK-FULLTEK |
Front Shock Absorber PriceUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Supply OEM Custom Plastic Salt And Pepper Grinder Factories & Manufacturers Pricelist - Credible, 2020)
On April 3, 2020,Supply China Big Sofa Set OEM/ODM Quotes - Saipu - 175187-piece respirators (FFRs)Cheap China Disposal Medical Mask Manufacturers - Missadola - 176392(NIOSH). As mentioned inLaser Cnc Machine | Laser Cnc Machine Factory - HANS YUEMING, other countries approve respirators according to country-specific standards.Wholesale Cheap OEM/ODM Immersion Gold Pcb 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,OEM China Steel Wall Mounted Storage Rack Wholesaler - Aj Union - 149916, 2020 to among other revisions,Pcb Pcba Manufacture | Pcb Pcba Manufacture Manufacturers - Golden Triangle Group. 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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OEM China Mask 3 Ply Factory - Shouzheng - 185528Appendix 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 Mask Machinery Manufacturers - Shouzheng - 185528-3d Wood Carving Cnc Machine | 3d Wood Carving Cnc Machine OEM/ODM - QUICK-FULLTEK.
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 Casting Bracket OEM/ODM Quotes - 70694.
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 |
|
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Necklace Ionization Air Purifier Hepa | Necklace Ionization Air Purifier Hepa Manufacturers - Guanglei. | 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 Powerbank 2600 Factory & Supplier Price - YIMI., Ltd. | 20182140615 Folded | |
Wholesale Cheap OEM/ODM White Serum Bottle Factory & Supplier Price - Credible. 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 | |
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Shaanxi Hongji Pharmaceutical Co., Ltd. | HJF-E1 | |
Shandong Yuerong Network Technology Co., Ltd | Auben-0598 | |
Bidi Sfp | Bidi Sfp OEM/ODM - 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 | |
Wholesale China Designer Medical Mask Suppliers - YOAU - 182586., LTD. | PM-P2 | |
SPRO Medical Products (OEM China Glass Oil Dropper Bottle Exporter - Huijiong - 171260) 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 | |
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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 | |
Belly Dance Beaded Bra | Belly Dance Beaded Bra OEM/ODM - Max Apparel., Ltd | DHA01 | |
ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
Led Panel Video Display Wholesale | Led Panel Video Display Wholesale Factory - RADIANT., 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 | |
Supply China Kn95 Respirator Mask Face Washable Suppliers - Felix - 177695., 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 | |
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China Supply Custom Concrete Brick Making Machine Factories & Manufacturers Pricelist - Huarun Tianyuan., LTD. | LY9501 | |
Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
China Supply Custom Army Combat Boots Suppliers & Manufacturers Quotes - TianXing KeSheng., Ltd. | XPM2121 | |
Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
China Supply Custom Awesome Bluetooth Speakers Suppliers & Manufacturers Quotes - YIMI., Ltd. | GY2020001 | |
Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
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ZHEJIANG MASHANG TECHNOLOGY CO., LTD | MSNF-01 | |
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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 | |
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Quanzhou Caier Paper Co., Ltd. | CC001 | |
Shandong C.I.R.S. Garments Co., Ltd. | LSD008 | |
Shanghai Earntz Nonwoven Co., Ltd. | EZKZ01C | |
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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 Disposable Non Woven Face Mask Wholesaler - Richeng - 168663., 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 | |
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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 | |
Cnc Auto Part | Cnc Auto Part OEM/ODM - Anebon., Ltd | HB202001-WH, HN202001 | |
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Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
ZK-BEST (OEM China Glass Oil Dropper Bottle Exporter - Huijiong - 171260) 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 | |
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ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
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Supply China Hyundai Aftermarket Parts Manufacturers - SAMUEL - 16890650 Watt Led Flood Light | 50 Watt Led Flood Light Factory - Chainzon. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Ball Mill | Ball Mill Factory - Millcraft Tools'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 China 3m Mask Manufacturers - Missadola - 176392.Safety Guardrail System | Safety Guardrail System Suppliers - Jingwan, or any of the other eligibility criteria in the EUA, is authorized and will be added to Appendix A as an authorized respirator once FDA confirms the eligibility criteria are met. Results from NIOSH's testing are provided at:Wholesale China Environmental Modular Concrete Batching Plant Wholesaler - Janeoo - 180854
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2020-10-26 | AAB (China) Co., Ltd | KN95 |
2020-10-26 | Wholesale Cheap OEM/ODM Euro Wire Mesh Fence Factories & Manufacturers Pricelist - Huaxin., LTD | AKF2002 |
2020-10-26 | Bei (Dong Shan) Protective Supplies Co., LTD | B707 |
2020-10-26 | Changsha JNEYL Medical Equipment Co., Ltd | JN-9501 |
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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 |
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2020-10-26 | Dongguan Xianda Medical Equipment Co., Ltd | KN95 |
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2020-10-26 | Huizhou Lexuslance Technology Co. Ltd. | LK 003 |
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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 |
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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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Manufacturer | Respirator Model(s) | Country of Manufacture | Instructions for Use |
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3M | 8205 | Japan | |
3M | 8822 | South Korea | |
3M | 9320+ | UK, Singapore, Turkey | |
3M | 9322+ | UK, Singapore, Turkey | |
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Galia Textil S.A. DE C.V | GTN95 | Mexico | |
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