No.
Revision:
Effective:
Page:
EZKZ01
V2.0
2020-03-28
Page 11 of 28
SHANGHAI EARNTZ NONWOVEN.,LTD
Technical File of Earntz Protective Face Mask
Page 13 of 28
Differential pressure
(Pa/cm 2 )
< 40
< 40
Splash resistance
pressure (kPa)
Not required
Not required
Microbial cleanliness
(cfu/g)
≤
30
≤
30
1.2 Previous and similar generation of the device
Overview of the previous generations of the device produced by the
manufacturer
: None
Overview of identified similar devices available on the Union or international
markets:
1.3 EC Authorized Representative
Folder 01 # CE-01-0102: EU authorized representative agreement
1.4 CND code
CND code:
1.5 Declaration of conformity
Declaration of Conformity for Face Masks is attached in the attachment.
Folder 01# CE-01-0103_Declaration of Conformity
