DEVICE DETAILS
| NAME OF DEVICE | Monoart Face Mask |
|---|---|
| ESTABLISHMENT NAME | AR DENTAL SUPPLIES SDN BHD |
| REGISTRATION NO | GA9608019-35032 |
| BRAND NAME | Euronda |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The Monoart® Face Masks are disposable medical devices and have been developed to offer total operational protection (the same standards as the Protection 4 range), but they also deliver the safety levels of hypo-allergenic materials which have been carefully sourced to respect sensitive skins and avoid the risk of irritation and dermatitis. |
| DEVICE INTENDED PURPOSE | Disposable hypo-allergenic face mask, composed by 4 layers: • Soft, coloured and water-repellent non-woven fabric with floral motifs; • PFE (Particle Filtration Efficiency) filter and BFE (Bacterial Filtration Efficiency) > 99%; • 2 layers of comfortable, absorbent non-woven fabric lining for effective absorption of sweat and moisture. It is ideal for protection from dust and aerosols: ΔP <3.0 mm H2O/cm2 in accordance with the EN 14683 standard (differential pressure: surgical mask breathability rating). Built-in nose bridge. |
| VALIDITY DATE OF REGISTRATION | 03/10/2019 - 02/10/2024 |