Declaration of conformity

  • This product meets the requirements of the "Administrative Measures for the Registration of Medical Devices" and related regulations.
  • This product complies with the classification requirements of the Medical Device Classification Rules.
  • This product complies with current national standards, industry standards, and provides a list of standards that meet the standards.
  • Our company promises to bear all legal liabilities related to this if it is false.

 
Technicaldatasheetofmedicalprotectivemaskproducts

  • Description: The medical protective mask is composed of a mask body (the upper and lower outer layers are spun-bond non-woven, and the middle is a high-efficiency melt-blown non-woven), a nose clip, and a mask band. The specifications are divided according to the population or packaging specifications of medical protective masks. The division of specifications does not change the performance indicators and expectations of the product. 

 

  • Material requirements: The medical protective mask is composed of a mask body (the upper and lower outer layers are spun-bond non-woven, and the middle is an efficient meltblown non-woven), a nose clip and a mask belt.

 

 

Medical mouth mask KN95 (FFP2)

Artikelnummer: CM00500
3,99 €Preis
  • Basic requirements for masks

    • The mask should cover the wearer's nose and mouth,and should have a goodfacial fit. There should be no holes, stains on the surface, and no exhalation valve.

    Nose clip

    • Masks should be fitted with nose clips and should be adjustable.

    Mask band

    • The mask band should be easy to adjust, have sufficient strength to fix the position of the mask, and the breaking strength of the connection point between the mask band and the mask is not less than 10N. 

    Filtration efficiency

    • At a gas flow rate of 85L / min, the filtering efficiency of masks for non-oily particles should be ≥95%.

    Airflow resistance

    • When the gas flow rate is 85L / min, the suction resistance of the mask must not exceed 343.2Pa (35mm H2O). 

    Synthetic blood penetration

    • 2ml of synthetic blood was sprayed on the mask at a pressure of 10.7kpa (80mm Hg). There should be no infiltration on the inside of the mask.

    Surface moisture resistance

    • The levelofwateron theoutersurfaceofthemaskshouldnotbe lowerthanthelevel3 in GB / T4745-1997. 

     Microbial index

    • Masks should be sterile 

    Skin irritation

    • Mask material's primary stimulus score should not exceed

    Tightness

    • The mask design should provide good adhesion, and the overall fit factor of the mask should not be less than 100

Contact:

Zur Herrgottsruhe 54

89335 Ichenhausen Germany

Pan.Li@commomed.com

Tel: +49-176 / 78816123

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