Product description
Product description
We’re proud to say that our masks are made of 100% British raw materials, manufactured right here in the UK.
Our masks have:
- Latex Free Elastic Ear Loops
- Nose Depression Strips
- GS1 Healthcare barcoding system – ensures full product/batch traceability
- An extremely competitive price point
Directives, Regulations, Standards, certifications, and procedures:
- Medical Devices Regulations 2002 (UK MDR 2002) Part II
- EN 14683:2019+AC:2019
- Directive 93/42/EEC on Medical Devices (EU MDD) Regulations of Annexe VII, Class 1
- MHRA registered (to view register entry click here)
- CE Marked (Link to full explanation)
- UKCA Marked (Link to full explanation)
- EN ISO 13485:2016/AC:2018 – QMS (supersedes EN ISO 13485:2016/AC:2016) working towards cert
- Exceptional filtration quality and breathability
- ISO 8 Cleanroom Fulfilment (packaging).
- GS1 128 Barcoding (NHS Healthcare GTIN conformity)
Mask textiles
Mask textiles
- Spunbond Non Woven PP -‘Inner Layer’, (layer closest to skin)
EN 14683:2019 and EN ISO 10993-1:2018 - Spunbond Non Woven PP -‘Outer Layer’, (Splash Resistant layer)
EN 14683:2019, EN ISO 10993-1:2018 and ISO 22609:2004 (Splash Resistance 16kpa) - Melt-Blown Filtration Media – ‘Middle Layer’, (Filtration layer)
EN 14683:2019, EN ISO 10993-1:2018 (Filtration Efficiency >98%)