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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.

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


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


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.