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The 3-layer medical protective mask consists of a filter layer placed between layers of nonwoven fabric. There is a nasal wire on the outer upper part of the mask. The mask has two ear straps to fit the mask.
Version of 3-layer protective mask and material:
Layer 1: inner layer of white non-woven fabric (100% polypropylene fibers)
Layer 2: White filter layer
Layer 3: outer layer of blue non-woven fabric (100% polypropylene fibers)
Nasal wire: plasticized steel wire
Ear bands: round elastic cord
Mask length: 175mm +/- 3mm
Mask width: 95 mm +/- 3mm
Nasal wire length: 100 mm +/- 3mm
The medical protective mask is disposable and non-sterile.
Compliance with the requirements of the European standard: EN 14683: 2019 + AC: 2019, CE marking
Tests performed in the European accredited laboratory Coronati Consulting Srl (Italy):
• 5370-20 Rev. 00 Cytotoxicity Test ✓
• 5780-20 Rev. 00 In Vitro Skin Irritation on Reconstructed Human Epidermis Test
Method (according to OECD 439) (
• 5779-20 Rev. 00 Bacterial Filtration Efficiency (BFE> 99%) (
• 5626-20 Rev. 00 Splash Test according to ISO 22609 ✓
• 6205-20 Rev. 00 In vitro Analysis of the Pro-Sensiting Potential ✓
• 5485-20 Rev. 00 Determination of Breathability (Diferential Presure) (
Certificates of conformity after tests performed at Lotrič Metrology (Slovenia)
• 589-10-20-2 Bacteriological filtration (BFE) efficiency test ✓
• 555-19-20-1 Respiratory test (air permeability) ✓
• 589-10-20-1 Liquid spray test ✓
• 10G022-2020 Biocompatibility test (cytotoxicity)
Packaging
Primarily, medical protective masks are packed in boxes of 50 masks. The boxes are equipped with instructions for use, manufacturer's name, date of manufacture, date of use and LOT number. Secondarily, the masks are packed in cartons of 20 boxes (1000 masks).
1 box / 50 masks
1 cardboard / 20 boxes
Storage
Store protective masks in a dry place.