Three-layer disposable surgical half mask, made of odourless, non-woven fabric, fibreglass-free, latex-free, hypoallergenic.
High fibre filtration and chemical resistance.
Heat-sealed trim, elastic harness fixed at four points, mouldable nose adapter for greater adaptability to facial profiles. The device prevents the escape of respiratory secretions, droplets and potentially infectious particles to the external environment but does not protect the wearer from fine aerosols that may contain very small infectious particles, such as viruses.
Surgical half masks are intended to prevent the wearer from contaminating the environment, as they limit the transmission of infectious agents and fall within the scope of medical devices under Legislative Decree 24 February 1997, n.46 and subsequent amendments and additions.
With Decree-Law no. 18 of 17 March 2020, surgical half masks (DM – Medical Device) available on the market are equated with PPE (Personal Protective Equipment).
They are produced in compliance with the technical standard UNI EN 14683:2019, which provides for characteristics and test methods, indicating the requirements of
- resistance to liquid splashes
- bacterial filtration efficiency
- cleanliness from microbes
The reference technical standard UNI EN ISO 10993-1:2010 has a general character for medical devices and provides for evaluation and testing within a risk management process.
CE marked – Conforms to Directive 93/42/EEC and subsequent amendments.