CE and FDA dual certification: introduction of medical surgical mask

by

TÜV SÜD CE certificate:No.G2S 101395 0003 Rev.00

China Class II Medical Device Registration Certificate: 京械注准20202140240

Type: Sterile/Non-sterile

Wearing Method: Ear-hang/Head-mounted

Typical applications:Medical Surgical Mask is suitable for basic protection of medical staff and relavant personnel, as well as protection against the spread of body fluids and splashes during invasive procedures.


Ear hanging type

Bandage style




Main material: It adopts the classic SMS three-layer structure design. The outer layer is water and moisture resistant, the inner layer is breathable and absorbance. The middle layer is 25g/㎡ melt-blown fabric, providing a phsical barrier to prevent the direct transmission of pathogenic microorganisms, body fluids, particles, etc..

 

Filtration efficiency: It can filter bacterial aerosols with an average diameter of 3 microns. Filtration efficiency is greater than 95%.

 

Fluid Pressure: Fluid pressure of the outer layer is greater than 120mmHg.







Product performance


Certificate details

FDA510K、K202029

ISO  13485 QMS Certificate 

CE Certificate


Sterile DOC

Non-sterile  DOC


EU registration Certificate


EN 14683 Standard Report


Reach Report


Biological ISO 10993 Report 


ASTM F2100 Report 


 ASTM YY0469 Test Report 


 Export sales Certificate


Customs qualification




China Certificate 

 Production License

Order consultation

Angela Qiu:13581890639

Chris:15911020280



Friendship Links:

百度一下   |   京东   |  

版权所有®2019BIOSISHEALING