Mascherina chirurgica IIR - 14683:2019 Dispositivo Medico Classe 1

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MADE IN ITALY

The study, the creation and the production are all made in Italy

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The mask skin test resulted as “Excellent”

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High quality with over 99% of breathability and with high filtering capacity untill 0,1 micron

DISPOSITIVO MEDICO CLASSE 1

“Class 1 Medical Device” certified mask

Surgical face masks for Type IIR medical use,non-reusable. They are suggested wherever it is impossible to keep the minimum anti-Covid-19 safe distance:

  • Working place;
  • Healthcare and medical places;
  • Crowded or for public use places

Their are mainly used to build a barrier which includes mouth and nose of who wears them. The IIR masks have a higher resistance to body fluids spray over the external surface than type I or II.

Three filtering layers

External protection:TNT filtering layer, non-woven fabric in durable material and Polypropylene 30 g/m2 Spundbond spray-preventing cover.

Filtering internal layer: High density Polypropylene Meltblown 25 g/m2 which is melted and blown in order to gather high performances, with electrostatic charge for nanoparticle capture. 

Layer in contact with skin: Polypropylene TNT non-woven fabric 30 g/m2 which is Spunbond skin-compatible and hypoallergenic.

Rubber band: Polypropylene and Spandex in high flexibility tubular cable.

All materials used are fiberglass free.

UV-C -sterilized TNT

Each non-woven fabric layer which forms the mask filtering system is individually sterilized at the production line entrance, in order to grant the high hygiene standard which characterises every Med IIR mask.

FAQ Questions and Answers

Which materials do the mask constitute?

More cover and protection.
MED IIR disposable surgical masks are 180 x 100 mm ( bigger than others in trade)
They are created with three fabric layers and rubber band for ears.
In detail:
• the first layer, the most external one, is spundbond 30gr non-woven fabric
• the second layer is made with high performing filtering non-woven fabric, melted and blown Polypropylene; Meltblown 25gr
• the third layer, in contact with the face, is made with Spunbond 30gr white non-woven fabric.
• The rubber band is polypropylene and spandex.

How can you wear and use the mask?

Before using the mask, it is important to wash the hands or use an alcohol hands sanitizer.

 

to wear the mask, use the rubber bands putting them behind the ears avoiding to touch the mask internal side.

 

Wear the mask covering mouth and nose. The mask lower edge must go under the chin.

 

The last step to wear the mask in the correct way consists in tightening the flexible part of the upper edge,in order to let the mask adhere to the nose.

 

These masks are disposable and must be substituted once used. It is necessary to follow a precise procedure to put off the mask, as when you put on it: the surgical mask must be put off starting from the rubber bands again avoiding to touch the internal side and then thrown into the rubbish.

How can you dispose of the mask?

Once used, the surgical masks must be immediately disposed of in a plastic bag and thrown into the recycling bin.

These masks are disposable and must be substituted once used. It is necessary to follow a precise procedure to put off the mask, as when you put on it: the surgical mask must be put off starting from the rubber bands again avoiding to touch the internal side and then thrown into the rubbish.

The National Institute of Health gives the provisions to dispose of the MED IIR disposable surgical masks. Regarding Covid-19, the institute distinguishes between domestic and working disposal.

Who stays at home due to positive Covid-19 test or in quarantene must dispose of the masks as unsorted waste. Before throwing them into the bin, it is preferable to put them into a separate plastic bag.
It is different for the working environment.In this case, the distinction is represented by the waste classification. In case of working activities whose waste is assimilated with the urban sorted one, masks must be disposed of following the standard procedure. If the companies produce other types of waste, it is necessary to follow specific rules which differs from the others basing on waste classification.

Anyway, it is important that disposable surgical masks are thrown into the right arranged containers. Regarding the domestic environment, masks must be put into the unsorted waste, while in the working place into signalled bins (basing on company rules), avoiding the ones into individual working spaces, cafeteria, toilet, ect.
It is important that companies put masks containers close to the exit, using specific bins that avoid the waste contact. Once thrown the mask away, do wash the hands or use the hands sanitizer.

Is it possible to re-use the masks?

The disposable surgical masks must not be washed. The contact with water let them be inefficient, eliminating the filtering effect. If you have a small quantity of Medical Devices, it is possible to disinfect them with a hydroalcoholic solution, which must be sprayed over the surface. After that, let them dry at the open air. In any case, it is preferable to change mask every use.

It is not suggested to re-use autoclaving surgical masks beacuse it seems that this treatment let the mask loose the filtering capacity.

MED IIR surgical masks have bigger dimensions than the avarage( 180x100mm) in order to grant the maximum wearability and higher safety.
The elastic round rings grant the correct adherence and the best wearability.

Thanks to their shape and the pleated design with nose clip, safety surgical masks fit easily each person face shape.

The bacterial filtering (BFE)> 99% and the high separation of aerosol containing virus and bacteria gives protection against the flu diffusion.

The surgical masks for medical use are tested in order to grant specific protection levels against saliva and other biological fluids penetration through mouth and nose. 

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Class 1 Medical Device surgical masks are tested to ensure specific protection levels

RII safety surgical masks act both blocking ill people respiratory secretions drops and avoiding that those drops or secretions spray or other biological fluids reach mouth and nose.

Type IIR masks satisfy the highest performance standard for spray-resistant masks and can be used in medical places for the patient protection against infective bacteria and for the medical staff protection from biological fluids contamination. All materials used are latex free.
Dimensions: 180×100 mm Type II R – disposable / non sterile Standard filtering: CE EN 14683: 2019+AC2019

An italian granted quality. Bromaslog requires the maximum quality for every product, starting from raw materials and during the whole production process wich takes place in Italy.

Conservation methods: keep the mask in dark, dry and well ventilated places, far from free flames and pollution sources.

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