Type IIR Disposable Medical Face Mask, called as disposable surgical mask, is only for one-time use, and it is prohibited to reuse, also
it shall be treated as medical device waste after use.
[Product name]：Type IIR Disposable Medical Face Mask
[Model ]：Hanger Type, Tie-on Type
[Specification]:17.5cm×9.5cm
[Product description/composition]:
The product is composed of mask body, nose bridge and ear loop. The mask body is made of three layers, the inner and outer layers are made of polypropylene non-woven fabric, the middle layer is made of polypropylene melt-blown fabric material.
[Contraindication]:
People allergic to non-woven fabrics are not allowed to use the product
[Caution]:
1.The disposable products should be destroyed immediately after use, and are not allowed to be discarded arbitrarily.
2.The product should be used as soon as possible after opening.
3.The mask should not be shared with others, cleaned or reused.
4.It is forbidden to use the damaged and expired products.
5.The mask should be replaced in time after it is wet or contaminated with the patient's blood or body fluids.
[Warning]:
1.This product is non-sterile and should not be used in a sterile surgical operation environment.
2.If any serious incident that has occurred in relation to the device. Please report to the manufacturer and the competent authority of your area.
[Method]:
1. Unfold the fold of the mask to make it fully extended;
2. Pinch the nose clip along the bridge of the nose until it fits;
3. Wrap the mask around the face and put on the ear hook at the same time;
4. Pull the lower edge of the mask to the lower jaw to ensure a large area of protection effect;
5. After wearing each time, the air tightness inspection must be carried out: cover the mask with both hands and exhale. If there is gas leaking from the nose clip, it is necessary to readjust the nose clip.
[The performance characteristics of the device]：
1.Bacterial filtration efficiency (BEF), (%) ≥98%.
2.Differential pressure (Pa/cm²) ＜60 Pa/cm².
3.Splash resistance pressure(kPa)≥16.0kPa
4.Microbial cleanliness (cfu/g) ≤30cfu/g.
(Meets EN14683:2019,Type IIR)
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