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Disposable medical mask

Class II medical devices

【Production license No】辽食药监械生产许20180016号

【Medical device registration certificate No】辽械注准20202140053

【Product technical requirement No】辽械注准20202140053

Certification

Type:

Ear hanging non-sterilization type

Size:

175mm×95mm

Main Structural Compositions:

This product mainly consists of the mask body, the strings and the nose clip. Of them, the mask body is made from non-woven fabric (as inner and outer layers) and melt-blown fabric (as interlayer) through thermal bonding.

Scope of Application:

Applicable for the health care in ordinary medical environments where the wearers have no body fluid and are not at risk of being sprayed.

Contraindication:

the use by anyone who is allergic to non-woven fabric is prohibited.

Product Performance:

1、The product should be clean and tidy in appearance and sound in shape, without damage or stain on the surface.
2、A nose clip is designed, made of plastic materials, with a length of 9.0cm.
3、The breaking strength at the connection between the string and the mask body is not less than 10N.
4、The bacteria filtration efficiency BFE of the mask is not less than 95%.
5、The ventilation resistance at both sides of the mask at the time of air exchange is not greater than 49Pa/cm3.
6、Total number of bacteria colonies≤100CFU/g, no Escherichia coli, Pseudomonas aeruginosa, Golden staphylococcus, Streptococcus hemolyticus or fungi may be detected.

Precautions, Warnings and Suggestions:

1、Please read the instructions carefully before use, and ensure the product is used within its shelf life.
2、After use, the product shall be disposed of as required by the hospital or environmental protection authorities.
3、This product cannot be used repeatedly; please do not use it as the package is damaged or gets wet.
4、Please wear as specified in the instructions for use.

Label, Identified graphics, symbol compilation:

Label, Identified graphics, symbol compilation

Storage:

store the product in a dry, ventilated and clean place at normal-temperature, free from corrosive gas.

Shelf life:

2 years