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
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Chris:15911020280
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