The face mask for medical use belongs
to class I, for rule 1 of Annex IX of the
Directive 93/42 / EEC, and meets the essential requirements
also referred to in Annex I of the same Directive
is subject to the procedure provided for in Article 11,
point 5 of the Medical Devices Directive 93/42 / EEC.
The medical face mask is one
half face mask for medical use, classified
as a NON-STERILE class I medical device.
Mask in non-woven fabric with high
filtering capacity, odorless, with three layers of
protection.
The three layers are composed of SMS ad polypropylene
high bacterial filtration capacity, BFE 95%.
The article is Latex Free (latex free) and not
contains any substance (additive, fragrance,
surfactant, plasticizers, resins etc.) added in
mass or with surface treatment that can
classify as toxic or allergenic.
A comfortable elastic applied to the ends will serve
to ensure better comfort for users.
On the upper side there is a conformable bar
to the nose.
Mask size: 175x90mm
Elastic size: 150x3mm per side
Registration ID
BD / RDM Ministry of Health: 1967039