Download declaration of conformity SAFE COMFORT REUSABLE 5-LAYER PROFESSIONAL FACE MASK
declaration of conformity
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SAFE COMFORT 5-LAYER REUSABLE MASK TYPE IIR
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
Made in Italy.
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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Products are subject to modifications without prior notice. We declare that some products carrying GIMA brand are manufactured by external OEM according to our specifications.
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