Description
The Safe Comfort mask consists of five layers of non-woven polypropylene sandwich laminates.
Each layer has a specific function: anti-splash, protective, filtering, dissipating, hypoallergenic.
Latex-free and phthalates free.
Biocompatibility and biological safety of materials.
- professional bacterial protection face mask made in ltaIy
- five-layer hypoallergenic material made in Germany
- maximum biological fiItration at surgical level in accordance with CE ISO 14683 Medical Device (type IIR)
- effective barrier against viruses, bacteria and spores in air dispersion and aerosols
- excellent nose-mouth breathability with spongy intermediate layer for dissipation of heat exhaled
- autoclavable, BFE tested up to 20 cycles
- reusable and machine washable (40°C - 35')
- one minute disinfection with a domestic microwave oven
- the innovative Safe Comfort design adheres perfectly and does not cause irritation and blisters
- elastic with easily adjustable self-adaptive sliding system
- absence of valve to avoid transmission of the virus
- the special shape of the nose piece allows you to position the protective glasses over the mask to prevent lens fogging
Multilingual box and instructions: GB, FR, IT, ES, PT, DE, GR, PL, SE, CZ.
DUAL CERTIFICATION :
- FACE MASK AGAINST COVID-19 PPE-RFU/02.075
- SURGICAL MASK M.D. EN 14683 TYPE IIR
Technical Specifications
Material: Non woven fabric, polypropylene, 5-layers with different density/thickness/texture
Bacterial Filtration Efficiency: Test BFE 99,9% exceed ISO Standard Annex B (BFE=98%)
Differential Pressure / Breathability: Test 53,9 Pa/cm2 exceed <60 Pa/cm2 / Type IIR Annex C
Microbic Cleanless: Test 12 cfu/g Bioburden exceed ISO EN 11737-1:2018 Annex D - <30 ufc/g
Blood Splash Resistant: = 16,0 (kPa) Type II R, EN 14683 Annex C
Reusable No.: X times (upon care when used)
Machine washable: 40°C-35' (Test BFE 99,9% after 5 wash)
Disinfectable: With alcool spray (isopropanol) No. X times
In microwave oven max 1’ - 700W No. X times
Autoclavable: In thermo-pouch at 121°C-28’ (Test BFE 99,9% after 20 cycles)
Conform to normative: UNI EN 14683:2019 Type IIR; ISO EN ISO 10993-1-5-10-12-18; ISO EN 11737-1:2018; ISO 22609:2005 EN 149:2001+A1:2009
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