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Surgical Medical Face Mask

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Surgical Medical Face Mask

Surgical Medical Face Mask

Surgical masks are fluid-resistant, disposable, and loose-fitting devices that create a physical barrier between the mouth and nose of the wearer and the immediate environment. They are for use in surgical settings and do not provide full protection from inhalation of airborne pathogens, such as viruses.
CUSTIMIZING YOUR PRODUCT

Description

A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. Surgical masks are regulated under 21 CFR 878.4040. Surgical masks are not to be shared and may be labeled as surgical, isolation, dental, or medical procedure masks. They may come with or without a face shield. These are often referred to as face masks, although not all face masks are regulated as surgical masks. Surgical masks are made in different thicknesses and with different ability to protect you from contact with liquids. These properties may also affect how easily you can breathe through the face mask and how well the surgical mask protects you. If worn properly, a surgical mask is meant to help block large-particle droplets, splashes, sprays, or splatter that may contain germs (viruses and bacteria), keeping it from reaching your mouth and nose. Surgical masks may also help reduce exposure of your saliva and respiratory secretions to others. While a surgical mask may be effective in blocking splashes and large-particle droplets, a face mask, by design, does not filter or block very small particles in the air that may be transmitted by coughs, sneezes, or certain medical procedures. Surgical masks also do not provide complete protection from germs and other contaminants because of the loose fit between the surface of the mask and your face. Surgical masks are not intended to be used more than once. If your mask is damaged or soiled, or if breathing through the mask becomes difficult, you should remove the face mask, discard it safely, and replace it with a new one. To safely discard your mask, place it in a plastic bag and put it in the trash. Wash your hands after handling the used mask. The similarities among surgical masks and surgical N95s are:
  • They are tested for fluid resistance, filtration efficiency (particulate filtration efficiency and bacterial filtration efficiency), flammability and biocompatibility.
  • They should not be shared or reused.

SPECFICATIONS

Product Name3ply medical surgical face mask ear-loop
Material Non-woven+ melt-blown layer + Non-woven
Fabric Type Standard
Feature Plat with earth loop
Size 17.5*9.5cm
Packing According to the quantity
Color White ,blue, green
Shipping time 3-7 days
Standard Chinese standard YY0469-2011/EN14683:2019

STandards

Mask belts should be comfortable to wear. The breaking strength of each mask at the mask body’s connection point should not be less than 10N.
Bacterial filtration efficiency (BFE)

The bacterial filtration efficiency of the mask should not be less than 95%. (Same as the bacterial filtration efficiency in “YY 0469-2011 Medical-Surgical Mask”)
The gas flow rate in the bacterial filtration efficiency test at 28.3 L / min. The strain used was Staphylococcus aureus ATCC 6538, and the average particle diameter (MPS) of its bacterial aerosol was (3.0 ± 0.3) μm.

Ventilation resistance

The ventilation resistance of the gas exchange on both sides of the mask should be no more than 49Pa / cm³.
The ventilation resistance test takes the center part of the mask for testing. The gas flow for the analysis needs adjustment to (8 ± 0.2) L / min; the diameter of the sample test area is 25 mm. The test sample test area is A. Use a differential pressure meter or equivalent equipment to measure the pressure difference between the two sides of the mask and calculate the ventilation resistance according to the formula ΔP = M / A.
ΔP-the pressure difference per square centimeter area of ​​the test sample, the unit is Paper square centimeter (Pa / cm³);
M ——The differential pressure value of the test sample in Pa (Pa);
A ——Test area of ​​test sample, unit is square centimeter.

Microbiological index

Non-sterile masks should meet the following requirements:
Total bacterial colonies (CFU / g): ≤100;
Coliform bacteria, Pseudomonas, Staphylococcus aureus, hemolytic streptococci, and fungi.: Not detectable.

The residue of ethylene oxide

If the mask is sterilized or sterilized by ethylene oxide, the residual amount of ethylene oxide should not exceed 10 μg / g.eo.

Biological evaluation

Cytotoxicity: The cytotoxicity of the mask should not be higher than level 2.
Skin irritation: The primary irritation score of the mask should not be higher than 0.4.
Delayed-type hypersensitivity: The delayed-type hypersensitivity of masks should not be higher than level 1.