88001-M-12 FP5 SAFECOMFORT DISINFECTABLE-AUTOCLAVABLE WITH ELASTIC FOR EARS – BOX WITH 12 PIECES

DUAL CERTIFICATION:

1- “FACE MASK AGAINST COVID-19” DPI-PPE-RFU/02.075-V2 / CE 0161 No. 2020/2803/00/0161

2- “SURGICAL MASK” M.D. EN 14683:2019 TYPE IIR / CE 1995672

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FEATURES

• Professional surgical protection face mask entirely manufactured in Italy by AXELMED

• 5-Layers pure PP TNT coupled material specifically made in Germany for AXELMED

• FILTRATION EQUIVALENT TO FFP3 (Filter Penetration Test with Sodium Clohride Standard EN 149:2001+A1:2009 point 8.11)

• Conformity also with EN 14683 TYPE IIR (R means Resistant to Blood and Saliva spatter)

• Half Mask certified AGAINST COVID-19 DPI-PPE-R/02.075-V2)

• The hypoallergenic tissue do not absorb bad-breath and the humidity exhaled

• Effective barrier against viruses, bacteria and spores in air dispersion and aerosols: Bacterial Filtration Efficiency BFE 99.9% tested with Staphylococcus Aureus with avarage diameter of 0,7 – 1,2 micron

• Excellent breathability with spongy intermediate layer for dissipation of heat exhaled

• The innovative SAFECOMFORT design adheres perfectly and does not cause irritations

• Absence of expiration valve to AVOID transmission of the virus also if worn by COVID-19 positive people or patients at risk

• Bacterial Filtration Efficiency (IN and OUT) BFE 99.9%

• Breathability <60 Pa/cm

• Bio-burden: ≥30 ufc/g

• Biocompatibility meets ISO 10993-1 face mask requirements

• Splash Test ≥16.0 kPa in conformity with EN 14683 Type IIR