88001-36 FP5 SAFECOMFORT AUTOCLAVABLE FOR 20 CYCLES AND STERILIZABLE IN MICROWAVE WITH ADJUSTABLE ELASTIC FOR HEAD-NECK – BOX WITH 36 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

 

REUSABLE – WASHABLE – AUTOCLAVABLE

• PERSONAL PROTECTIVE EQUIPMENT “MASK AGAINST COVID-19″ (PPE-R/02.075-V2)
• MEDICAL DEVICE CE EN 14683 TYPE II R
• WITHOUT VALVE WITH BFE BACTERIAL FILTRATION EFFICIENCY >99%
• BREATHABILITY UP TO 5 TIMES BETTER THEN A DISPOSABLE FFPx MASK
• BUY ONCE, SAVE MONEY: CAN BE REUSED FOR ONE MONTH
• MACHINE WASHABLE , QUICK DISINFECTION WITH ALCOOL-SPRAY, 1 MINUTE STERILIZATION INTO MICRO-WAVE OVEN, AUTOCLAVABLE  DAILY UP TO 20 TIMES IN SEALED POUCH FOR STERILE USE
• ECOLOGICAL: REDUCE WASTE OF DISPOSABLE MASKS

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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

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

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

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

• 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

• Reusable for months and machine washable (40 ° C – 35 minutes) – ATTENTION: due to the spatter resistant properties of the external layer, the stamp on the mask may may fade after washing.

• One minute disinfection with a domestic microwave oven even everyday

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

• Adjustable soft elastic tubulars with self-adaptive sliding system (very long: can be tighten outside the protective suit hood or head covers)

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

• The special shape of the nose piece allows to position the protective glasses over the mask to prevent fogging

• Bacterial Filtration Efficiency (IN and OUT) BFE 99.9% (>99,9% after 5 cycles in machine washer 40°C x 60′ –  >99.9% after 20 cycles in Class B Autoclave 128°C x 28′)

• Breathability <60 Pa/cm (53.9 Pa/cm2 after 5 cycles in machine washer 40°C x 60′ – 55.1 Pa/cm2 after 20 cycles in Class B Autoclave 128°C x 28′)

• Bio-burden: ≥30 ufc/g, exceed ISO EN 11737 (bacterial contamination after production: 12 cfu/g – Moulds 2.6 cfu/g – Yeast <0.4 cfu/g)

• Biocompatibility meets ISO 10993-1 face mask requirements

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