Supplier From
Frauenfeld,
Turgovia,
Switzerland
Supplier From
Frauenfeld,
Turgovia,
Switzerland
Protection for people and workers who place great value on facial expressions such as children, people with hearing problems, police forces and nurses. The mask can be used also as non-sterile mask in hospitals and vaccine centres. No fogging of glasses thanks to extra soft nose pads.
Colour: Black and white
Size: Standard and children
Box: 50 pieces
Languages: Italian, French, German, English, and Spanish
Brand: ST-Cleantech AG
Classification / Standard: Medical device: Class I / according to DIN EN14683:2019.
Material: Consisting of: non-woven fleece layer PP, filter material PP manufactured in meltblown process, PP window (13.4x3.7x0.2 cm) ultrasonically welded latex-free, nose clip, aluminium wire PE coated, ear bands made of elastane.
Level of performance: According to type IIR (same test standard to be applied).
Filter efficiency antibacterial (BFE): Norm: 98% - Test result: 99.9%. (according to EN 14683:2019+AC:2019, Annex B).
Respiratory resistance: Standard: <60 (pa-m) - Test result: <59.7 (pa-m) / Flow rate: 8l/min. (according to EN 14683:2019+AC:2019, Annex C).
Resistance to pressure spray: Standard: 16 kPa - Test result: <21.3 (kPa) / AQL 4.0%, the highest corresponding blood pressure (according to ISO 22609:2004)
Microbiological purity: Standard: <30 cfu/g - Test result: Average of 5 samples: 12.80 cfu/g (according to EN 14683:2019+AC:2019, Annex C)
Dimensions mask: 17.5 x 9.5 cm x 2 mm
Dimension mask kids: 14.5 x 9.5 cm x 0.2 cm
Size Packaging primary: 20 x 8.5 x 10 cm (LxBxH)
Size Packaging primary kids: 16.5 x 10.5 x 8.5 cm (LxBxH)
Weight Primary packaging: 189 g
Weight Primary packaging kids: 180 g
Size / Content Secondary packaging: 53 x 46 x 42 cm (LxWxH) / 50 boxes of 50 pieces: 2'500 pieces.
Size / Content Secondary packaging kids: 54.5 x 35.5 x 36.5 cm (LxWxH) / 40 boxes of 50 pieces: 2'000 pieces.
Weight Secondary packaging: 10.4 kg
Weight Secondary packaging kids: 7.7 kg
EC representative: SC ENIF PEGASUS SRL Bucuresti sector 2. Strada RADOVANU Nr.7 Bloc 42., scara 1. Etaj 5 Ap29
Certification manufactured: EN ISO 13485:2016 / EN ISO 14971:2012 / EN 1041:2008 / EN 15223-1:2012 / EN ISO 10993-5:2009 / EN ISO 10993-10:2013 / EN 62366:2008 / EN 14683:2019+AC:2019
Importer: ST Cleantech AG. Address: Hunger elstrasse 12, CH-8500 Frauenfeld
