COMPLIANCE

TYPE II and TYPE IIR Medical and Surgical Face Masks: Not Just Anything Will Do

 Our 3-Ply Medical and Surgical Face Masks are medical device:

 

  • 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.
  • Tested and evaluated to be Type IIR against EN14683:2019 by CENTEXBEL, Belgium, Europe.
  • Level 3 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.

Tuv Rheinland LGA Products GmbH – Tillystrabe 2 – 90431 Nurnberg Germany
Http://www.tuv.com/safety
EN ISO 13485: 2016 (EU)
Effective Date: 15 June 2020

Nelson Laboratories, LLC
6280 S. Redwood Road, Salt Lake City, Utah, 84123 U.S.A
www.nelsonlabs.com
ASTM F2100-19 (American Society for Testing and Materials, USA) 
Effective Date: 31 March 2020

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