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Protective Face Mask

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Protective Face Mask

Description

Disposable Protective Face Mask is a device used to filter the air entering the nose and mouth to prevent harmful gases, odors, and droplets from entering and leaving the wearer’s mouth and nose.
Personal Protective 3 Ply Face Shield can prevent most pathogens like bacteria and viruses from preventing viral infection in the hospital air.

SPECFICATIONS

 
Product Name
Protective disposable face mask
MaterialNon-woven Fabric
Non-woven Fabric
Feature
Adjustable nose piece, Elastic ear-loop ,3 layer mask
Function
anti-virus / prevent flu / anti smoke / dust
valve
without valve
Size
17.5cm*9.5cm
Certification
CE  FDA  SGS

STandards

Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20. FDA currently believes such devices would not create such an undue risk where:

The product includes labeling that accurately describes the product as a face mask (as opposed to a surgical mask or FFR) and includes a list of the body contacting materials (which does not include any drugs or biologics);

• The product includes labeling that makes recommendations that would reduce sufficiently the risk of use, for example, recommendations against: use in any surgical setting or where significant exposure to liquid, bodily or other hazardous fluids, may be expected; use in a clinical setting where the infection risk level through inhalation exposure is high; and use in the presence of a high intensity heat source or flammable gas; and

The product is not intended for any use that would create an undue risk in light of the public health emergency, for example the labeling does not include uses for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses and does not include particulate filtration claims.