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Some medical masks may be classified as source control per Emergency Use Authorization (see link in "COVID-19 Regulatory Updates & Advice >"). Contact us for more details > EU. Classified as either a Class 1 or Class 2 medical device, medical masks destined for the EU market must meet the labeling requirements of the corresponding standards. Protective Face Masks, GB 2626-2019 and EN 149:2001 + A1 May 29, 2020 · Protective face masks are classified as PPE in the EU and are subject to the requirements of Regulation (EU) 2016/425 and performance tests according to EN 149:2001+A1:2009. The Chinese counterpart is GB 2626-2019, but it is not equivalent to EN Respiratory Protection Industrial Face Mask uvex safetyRespiratory masks and filtering half-masks in accordance with standard DIN EN 149 protect the wearer from particulate pollutants such as aluminium dust and smoke, glass fibres, wood dust and other harmful particles. Depending on the type and concentration of the pollutant, one of three protection classes of face masks must be available.
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