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Surgical grade IIR, 3-ply protection mask

Surgical-grade, sterile IIR face mask, manufactured under standard EN ISO 13485:2016

Surgical grade IIR, 3-ply protection mask
Surgical grade IIR, 3-ply protection mask
Surgical grade IIR, 3-ply protection mask
Surgical grade IIR, 3-ply protection mask
Materials

3-layers:
(1) Polypropilene spunbond non-woven fabric, 25gsm, white color
(2) polypropylene melt blown fabric, 22gsm, white color
(3) polypropylene spunbond non-woven fabric, 16gsm, green color.
Loose ties type. Nose bridge: nickel-free metal strip

Technical specifications

• IIR-type mask as per EN 14683:2019 Norms
• High Bacterial Filtration Efficiency (BFE) ≥ 99%
• Differental pressure 2.5 mm H2O/cm2 (3 µm)
• Splash resistance pressure ≥ 16 kPa
• Latex particle challenge 0.1 µm

Certifications

• Product certified as per EN 14683:2019 IIR norms
• CE certification according to Directive 93/42/EEC
• Conformity to MDD 2007/47/ED
• NELSON Test for Bacterial Filtration Efficiency (BFE)
• NELSON Test for Differential Pressure (ΔP)
• NELSON Test for Microbial Cleanliness
• NELSON Test for Blood Penetration Resistance
• Fulfil requirements for ASTM F2100 Level 2
• Designed for medical, surgical and food use

Packaging

• Mask size 18cm x 9.5cm folded
• 50 pcs in a box
• Export carton size: 50 x 20 = 1000 pieces
• Carton weight: 7 kg (40 boxes)

Personal Protection Equipment

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