No.
Revision:
Effective:
Page:
EZKZ01
V2.0
2020-03-28
Page 7 of 28
SHANGHAI EARNTZ NONWOVEN.,LTD
Technical File of Earntz Protective Face Mask
Page 7 of 28
1.1.7 Contraindications
None
1.1.8 Waring and Cautions
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If there is redness, swelling and itching after usage, please stop using it and consult
your physician.
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Only for single use.
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Stay away from fire.
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Correctly distinguish the front and back prior to use.
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The device should be stored in a dry room with excellent ventilation and without
caustic gases.
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Can not be used on surgical operation condition.
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Not suitable for children under 3 years old.
1.1.9 Description of the principle
Non-woven fabrics have the characteristics of water repellency, air permeability,
flexibility and light weight. Therefore, choosing suitable thickness of outer non-woven
fabrics can protect the wearer from potential contaminated liquid splashing. In addition,
the fiber diameter of the intermediate melt-blown filter layer can be as small as 1-
5μm.
These fibers with unique capillary structure can increase the number and surface area
of fibers per unit area, effectively filter bacteria and dust, and prevent the spread of
infectious pathogens. In addition, the design of nose clip and the design of mask stack
can make the mask fit the shape of face, thus reducing the probability of infectious
pathogens entering from the side.
1.1.10 Rationale for the qualification of the product
We, SHANGHAI EARNTZ NONWOVEN.,LTD, hereby claim that, as legal
manufacturer, we have established and maintained a quality management system
according to Regulation 2016/425 for manufacturing of personal protective
equipment.
1.1.11 Classification rule(s)
Device Name:
Protective Face Mask
According to Regulation (EU) 2016/425 :