TYPE II Medical and Surgical Face Masks: Not Just Anything Will Do.
Our 3-Ply Medical and Surgical Face Masks are medical devices:
- Manufactured in an EN ISO 13485 European Standard certified facility.
- Tested and evaluated to be Type II against EN14683:2019 by CENTEXBEL, Belgium, Europe.
- Level 1 against ASTM F2100:19 by Nelson Labs, USA, is U.S. Food and Drug Administration (FDA) registered and ISO 17025 accredited.
- Test conducted by the herein listed Independent Notified Bodies in the EU and USA as regulated.
- Approved as Medical Device for Healthcare professional use, Hospital graded.
- All our products carry a QR code which is traceable to source of Manufacturer with Compliance Certification issued by Accredited Notified Bodies.
CENTEXBEL, Belgium, Europe
CENTEXBEL is a Notified Body #0493
EN14683: 2019 (EU)
Summary: This test report is valid for products used in relation to the current Covid-19 health crisis and for products which are not entering the regular distribution channels. Cfr Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the Covid-19 threat.
HOW TO ORDER
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