Certificates

Our factory in Hong Kong is ISO 13485 Quality Management System Certified with ISO 14644 Cleanroom. Additionally, all our masks are medical masks that passes the ASTM Level 2 Standard.

Unlike our price gorging competition, all our factory and product certificates are approved by world accredited laboratories. All our products at Medcross are made exclusively for and by our single factory in Cheung Sha Wan.   

 

Approved by Nelson Laboratories (Salt Lake City, UT):
ASTM F2100-19e - Level 2
ASTM F2100-19 - Level 2
ASTM F2100-11(2018) - Level 2
EN14683:2019 Type IIR

Full List of Certificates

https://www.medcross.co/features.html

 

US CDC appoints Nelson Laboratories as the testing center for F2100 standard.  (US CDC PPE Guidance Information)

BFE Report. BFE > 99%
(Compliant with ASTM Level 2)

PFE Report. PFE > 99
(Compliant with ASTM Level 2)

VFE Report. VFE > 99%

Blood Resistance Report > 120mmHg
(Compliant with ASTM Level 2)

Microbial Report. < 30CFU
(Compliant with EN14683:2019 Type IIR)

Medical Devices QMS
ISO 14644-1:2015 Certification