MASK NOT WRAPPED

The term surgical masks refers to disposable masks approved by the Ministry of Health, Labor and Policies
social security for use as medical devices according to national and community legislation (Directive on Medical Devices 93/42 / EEC for
hygienic masks) European standard EN 14683: 2019 for surgical masks intended to limit the transmission of infectious agents from staff to patients and vice versa, in certain situations during surgical procedures in operating blocks and other medical environments with similar requirements.

The MAS Opera 1 mask is considered a Medical Device – class I.

In compliance with the European technical standard UNI EN 14683 , surgical face masks are classified into two different types, TYPE I and TYPE II , depending on the efficiency of bacterial filtration . Type II also differs into type II and TYPE IIR , depending on the resistance to splashes .

The MAS Opera 1 bezel is considered a Type IIR device.

The composition is on three layers:

• EXTERNAL layer (world side): Fabric – non – woven (TNT) 100% polypropylene produced with SPUNDBOND technology of 30 g / m2 with hydrophobic treatment; this layer has the function of conferring mechanical resistance to the mask and hydrophobic properties.
• INTERMEDIATE layer (filtering): AXAR M35, fabric produced with SMS technology of 35 gr / m2 and consisting of 1-3 micron diameter microfibres, this layer performs the filtering function ;
• INTERNAL layer (mouth side): Fabric – non – woven (TNT) 100% polypropylene produced with SPUNDBOND technology of 30 g / m2 with hydrophobic treatment and protective function for the face; OEKOTEX certified material suitable for skin contact .