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Surgical Face Mask - Ear Loop | Standards: FDA class II medical device, level 2 | Approvals: FDA Cleared (510K) | Type: FXX

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Product Description

This healthcare surgical mask is designed to help protect the wearer. It meets FDA guidelines for Mycobacterium tuberculosis exposure control. As a disposable particulate surgical mask, it is designed to be fluid resistant to splash and spatter of blood and other infectious materials.

Layer 1
(outer layer): water-repellent Polypropylene non-woven fabric to
prevent the penetration of moisture, mist, saliva


Layer 2
(center layer): Meltblown Nonwoven. Insulate the virus to invade
the bacteria, electrostatically absorb the virus to achieve a blocking effect
of more than 99%, prevent the virus infection between the patient and
medical staff, and block the inhalation of micro bacteria, micro powder
and micro mold.

Layer 3
(inner layer): It is hydrophilic and water absorbent, which can
completely absorb the moisture when breathing, and it is comfortable
and dry to wear.

Instruction:
Please stretch out the mask and hang it on your ears, adjust the
bridge of the nose and press it tightly

Lab test result:

Particle Filtration Efficiency (PFE) > 89.80% (Particle Size 0.075 micrometre)
Bacterial Filtration Efficiency (BFE) > 99.8% (mean particle size 3.0 ± 0.3 micrometre)
Inhalation Resistance 93.88
Exhalation Resistance 91.43
Flammability "DNI" Did Not Ignite
Synthetic Blood Penetration Resistance (Test Pressure 80 mmHg) Pass


Specification:

Type: Flat shape, 3-ply, sterile
Color: Blue
Outer Layer: Water repellent non-woven
Middle Layer: High-level static Filtration non-woven
Inner Layer: Microfiber Thermal bond non-woven
Noseband: PE Iron Wire
Packaging: 50 Pcs/box, 40 boxes/ctn
MADE IN TAIWAN

Caution:

Do not pull the body of the face mask over from between the face and the mask.
Replace with a new set of face mask upon entering or exiting the potentially infectious area and at times when either one become unusable (i.e. has a rip or a tear) Replace when there is an unusual smell in breathing. Avoid contact with the outer surface of the face mask when taking it off to prevent infection and contamination. Store in a cool and dry place.