Technical specifications
- Class I medical device
- Flat mask with 3-ply, easy to wear with earloops
- Bacterial filtration efficiency greater than 98%
- Splash resistance pressure greater than 16 kPa
- Microbial cleanliness less than 30 cfu / g
- Breathability: the differential pressure is less than 40 Pa
- Single use - Maximal use duration: 8 hours uninterrupted
- Shelf life: 3 years from manufacturing date (Refer to expiry date on the label)
Materials
- Mask body (17.5 x 9.5 cm) with:
- 1 outer layer of polypropylene (PP) nonwoven fabric
- 1 middle layer of polypropylene nonwoven melt blown
- 1 inner layer of polypropylene (PP) nonwoven fabric
- Nose clip composed of flexible plastic piece laminated with aluminium wire
- Earloop in polyamide and polyurethane
Security
- Product quality guaranteed by in-process and final product inspections
- Produc performances tested according to the EN 14683 standard
- Product biocompatibility tested according to the ISO 10993-1 standard
- CE mark under the Medical Devices Regulation (EU) 2017/745
- Product type IIR : HS code 630790010
Packaging
- Box of 50 units
| Weight (box) | 0.440 kg |
|---|---|
| Dimensions (box) | 18 × 10 × 7 cm |
| Minimum quantity | 5 boxes |
| Units per box | 50 |
| Countries allowed to order | Austria, Belgium, Bulgaria, Cyprus, Denmark, Finland, France, Ireland, Luxembourg, Malta, Netherlands |
| Shipped from | 15th May 2020 |
