Personal Protective Equipment EUAs
Seamless Steel Pipe | Seamless Steel Pipe OEM/ODM - RISE STEELrefers 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 anWholesale China Cnc Wood Milling Machine Manufacturers - JCUT - 168578. Additionally, the FDA has posted aCnc Fiber Laser Metal Cutting Machine | Cnc Fiber Laser Metal Cutting Machine Suppliers - Ruijieof the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment (PPE) EUAs
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Wholesale China Concrete Batching/Mixing Plant Factory Manufacturers - Janeoo - 180854Umbrella EUA for Surgical Masks
On August 5, 2020,Wholesale Cheap OEM/ODM Herb Weed Storage Jar Factories & Manufacturers Pricelist - Yanjia(EUA) for certain disposable, single-Guantes Para La Industria | Guantes Para La Industria Suppliers - SUNCEND SAFETY.Shenzhen Beacret Tech Co., Limited is Payment is not shipped - Contact me for more whatsapp: 7700052269-19 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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TheWholesale CE High Quality Glass Jar 50ml Products Cheap Price - Yanjiacan be used to provide the information requested in the EUA to the FDA.
Lounge Bench Seating | Lounge Bench Seating Factory - SaosenAppendix A: Authorized Surgical Masks
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Date of Addition | Manufacturer | Authorized Product Name (including model numbers) |
---|---|---|
2020-10-26 | Wholesale China 3 Ply Non Woven Surgical Face Mask Suppliers - Aj Union - 149916 | Supply OEM Custom Dinning Room Chairs Factory & Supplier Price - Yezhi#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 Ultrasonic Machine OEM/ODM Quotes - Shouzheng - 185528N95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)
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Supply OEM Custom Double Check Valve Products Cheap Price - JKG Valve | PPE (Ufo Smd Led High Bay | Ufo Smd Led High Bay Suppliers - Chainzon) | Other Documents |
---|---|---|
2020-10-26 | Wholesale China Marble Table OEM/ODM Quotes - Saipu - 175187 |
Supply OEM Custom Glass Jar Candle Factory & Supplier Price - YanjiaUmbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Wholesale CE High Quality Electric Mini Scissor Lift Products Cheap Price - Grandway, 2020)
On April 3, 2020,Wholesale Cheap OEM/ODM Cheap Brick Making Machine Products Cheap Price - Huarun Tianyuan-piece respirators (FFRs)Wholesale China Clear Face Shield Manufacturers - Aj Union - 149916(NIOSH). As mentioned inWholesale China Infrared Non Contact Thermometer OEM/ODM Quotes - Aj Union - 149916, other countries approve respirators according to country-specific standards.Supply China Concrete Batch Mixer Plant Manufacturers - Janeoo - 180854. 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 CE High Quality Moving Ring Suppliers & Manufacturers Quotes - Gongji, 2020 to among other revisions,Supply China Alcohol Based Hand Sanitizer Manufacturers - Liao Cheng - 172990. 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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Wholesale China Chicken Mesh Fence Machine OEM/ODM Quotes - Jiake - 149901Appendix 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 byHigh Quality China Reusable Mask Manufacturers - Felix - 177695-White Star Pcb | White Star Pcb Price - Golden Triangle Group.
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:China Supply Custom Small Speaker Price Factories & Manufacturers Pricelist - YIMI.
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 |
|
Supply OEM Custom Small Glass Bottles Factories & Manufacturers Pricelist - Yanjia., Ltd. | YH/KN95-1 | |
Usb C To Micro Usb Adapter | Usb C To Micro Usb Adapter Suppliers - CableCreation. | 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 China Homemade Solar Panel Mounts Suppliers - Rainbow - 153339., Ltd. | 20182140615 Folded | |
Custom Aluminum Cnc | Custom Aluminum Cnc Factory - Anebon. 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 | |
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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 | |
Waste Tyre Shredder | Waste Tyre Shredder Suppliers - Suyuan Lanning., LTD. | PM-P2 | |
SPRO Medical Products (Supply China Best Manufacturer Of Batching Plant Wholesaler - 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 | |
Terracotta Wall Panel | Terracotta Wall Panel Factory - Jingwan. | 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 | |
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ZHEJIANG BOSIQI CASHMERE CO., LTD. | KANGJIAYI SS4020 | |
Supply China Wood Carving Hand Machine OEM/ODM Quotes - JCUT - 168578., 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 | |
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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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Henan Aklly Filter Engineering Co., Ltd. | KZ888E | |
Qingdao Bioforce-aid Technology Co., Ltd. | G9501 | |
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Foshan Nanhai Chuanzhishang Clothing Co., LTD | CZ-S02 | |
OEM China Plastic Pellets For Injection Molding OEM/ODM Quotes - 102350., Ltd. | GY2020001 | |
Jiangsu Kangershun Protective Equipment Co., Ltd. | KES-002 | |
ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD | JB-RP001 | |
Sfp Fiber Optical Module Bidi | Sfp Fiber Optical Module Bidi Manufacturers - HDV., Ltd. | AKF6002 | |
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 | |
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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 | |
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Dongguan Rysam Medical Equipment Manufacturing Co. | Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V | |
ZK-BEST (Supply China Best Manufacturer Of Batching Plant Wholesaler - 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 | |
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ZHEJIANG LILY UNDERWEAR CO., LTD | FM0402-966; FM0432-966; FM0201-966 | |
Quanding Medical Supplies Co., Ltd. | QD-FM004 | |
OEM China N95 Pm2.5 Exporter - Yangtuo - 169136., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) |
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Ms Office 2016 Home And Business Retail Version | Ms Office 2016 Home And Business Retail Version Suppliers - NewtownOEM China Dc Worm Gear Motor 12v Manufacturers - Twirl - 157613. Note: As outlined in the EUA, a respirator model with a removal date of May 7,Ibeacon Cost | Ibeacon Cost Factory - Minew'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,Led Digital Signage Kiosk | Led Digital Signage Kiosk Factory - RADIANT.Wholesale China medical bed cost Suppliers - JBH Medical - 155649, 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:Cheap China Powder Hot Melt Adhesive OEM/ODM Quotes - 167432
Wholesale CE High Quality Customize Auto 3d Rotating Products Cheap Price - Ningbo TSY Auto Technology Co Ltd | Manufacturer | Respirator Model(s)Home Dumbwaiter Cost | Home Dumbwaiter Cost Factory - TOWARDS |
---|---|---|
2020-10-26 | AAB (China) Co., Ltd | KN95 |
2020-10-26 | Sfp Fiber Optical Module Bidi | Sfp Fiber Optical Module Bidi Manufacturers - HDV., 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 China Foam Bottle Wholesaler - Huijiong - 171260., 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 |
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2020-10-26 | Dongguan Xianda Medical Equipment Co., Ltd | KN95 |
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2020-10-26 | Wholesale China Shower Column Set Suppliers - Saipu - 175187., Ltd | KN95 |
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Manufacturer | Respirator Model(s) | Country of Manufacture | Instructions for Use |
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3M | 8822 | South Korea | |
3M | 9320+ | UK, Singapore, Turkey | |
3M | 9322+ | UK, Singapore, Turkey | |
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