Surgical masks for adults and children

The first production line is exclusively dedicated to the production of surgical masks. Three types of masks can be produced with a filtration efficiency (BFE = Bacterial Filtration Efficiency) of minimum 98%.

• For adults
• For children
• With virucide for adults

Our surgical masks are registered as type II with the Ministry of Health of Luxembourg and on Eudamed.

Mask composition

Surgical masks must be composed of three layers, delivered exclusively by European suppliers.

• A first inner layer (S): “Spunbound
• An intermediate layer (M): ” Meltblown ” (this is the filtering layer)
• A third external layer (S): ” Spunbound “.

To these three layers is added a stem (“nosebridge”) for a better fixing of the mask around the nose as well as resistant elastics for a good maintenance around the ears.

Certifications

The compliance tests were performed in French laboratories approved according to the EN 14683+AC:2019 standard, including:

• The filtration test: BFE (Bacterial Filtration Efficiency) of minimum 95% for Type I masks and minimum 98% for Type II and IIR masks
• Breathability test: a measure to quantify the ease of breathing through the mask (comfort)
• The microbial cleanliness test: this test ensures that the masks are made in cleanliness conditions that comply with the standard
• The splash test: type IIR: to ensure that droplets are well retained by the mask

A self-certification validated by the Luxembourg Ministry of Health was possible thanks to all these conclusive tests and a complete technical file. The tests allowed us to obtain the European standard EN 14683+AC:2019.

Santé Services has obtained the “Made in Luxembourg” label for its Type I and Type II surgical masks.

FFP2 masks

An additional production line is dedicated exclusively to the production of FFP2 masks. These masks are certified by the Notified Body Eurofins Italy, number 0477.

Mask composition

FFP2 masks are composed of five layers of different raw materials:

• A first external non-woven layer
• A second layer of cotton
• A third central layer of Meltblown for filtration
• A fourth layer of cotton
• A fifth layer of non-woven

In addition to these five layers, a 5mm wide nosebridge allows the mask to be better fixed around the nose, as well as resistant elastics for a good hold around the ears and to avoid possible pain.

In addition, the presence of a double-sided medical tape allows the user to stick the mask to his nose and thus perfect the absence of leakage for the mask.

Certifications

All the certification was carried out by a “Notified Body”, one of the only bodies with the authority to issue CE certificates for category 3 personal protective equipment. The “Notified Body” that accompanied Santé Services in this process is Eurofins Italy. The standard followed is EN149:2001+A1:2009. The following tests have been performed and validated:

• Leakage test: air leakage outside the mask filtration must be less than 11% for FFP2
• Filtration test: the filtration of hydrophilic (NaCl) and hydrophobic (Paraffin) liquids must be higher than 94%.
• Skin compatibility test: this test ensures that the masks do not cause any skin discomfort (redness, irritation, etc.)
• Flammability: the device must not catch fire
• Content of CO² in the inhaled air: the content of Carbon Dioxide must not exceed 1% by volume for 5% of exhaled air
• Respiratory resistance: composed of 3 tests:
  • Inhalation at 30L/min: must be less than 0.7 mbar
  • Inhalation at 95L/Min: must be less than 2.4 mbar
  • Exhalation at 160L/Min: must be lower than 3.0 mbar
• Penetration of filter material:
  • Filtration of hydrophobic liquid (Paraffin) at 95L/Min, must be less than 6% i.e. a filtration > 94%.
  • Filtration of hydrophilic liquid (NaCl) at 95L/Min, must be less than 6%, i.e. a filtration > 94%.
• Content of CO² in the inhaled air: must be less than 1%.
• Leakage test: the air leakage outside the mask filtration must be less than 11% for FFP2
• Skin compatibility test: this test ensures that the masks do not cause any skin discomfort (redness, irritation, etc.)
• Flammability: the device must not catch fire

Santé Services has obtained the “Made in Luxembourg” label for its FFP2 masks via the Chamber of Commerce. Our masks are customizable for companies and individuals, but also for events with logo printing on request.

MedLogistics
9, rue Edward Steichen
L-2540 Luxembourg
info@medlogistics.lu

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