- Date of issue and edition: 2020-05 V1.0
- [Product name]: Disposable Medical Mask
- [Model]: J80
- [Specification]: (175±5%) x (95±5%) mm
- [Intended Use]: Disposable Medical Mask is used for people in order to reduce the risk of the spread of infections,and it is not intended for use by healthcare professionals in an operating room or in other medical settings with similar requirements.
- [Product description/composition]: The product is composed of mask body, nose clip and mask ribbon. The mask body is composed of nonwoven fabric and meltblown fabric; the nose clip is composed of galvanized iron wire and PE; the mask ribbon is composed of nylon and spandex.
- The product is disposable and non-sterile.
- [Contraindication]: People allergic to nonwoven fabrics are not allowed to use the product.
[Caution]:
- Check the integrity of the package before use. If the package is damaged, it is strictly prohibited.
- This product is for single-use and cannot be washed.
- Confirm the package identification, production date and validity period and use them within the validity period.
- Ensure that the mask covers the bridge of the nose to the lower jaw after being unfolded so as to obtain the desired protective effect.
- It is recommended to use continuously for no more than 4 hours.
- After the mask is wet and contaminated by the patient's blood and body fluids, replace it in time.
- This product should be disposed of as medical waste after use.
- It is not recommended to wear this product when the air is not circulating, breathing is not smooth or sleeping.
- Please keep in the shade and out of the reach of children.
- Children under three years old are not recommended because of their low vital capacity.
- This product cannot be used in a sterile surgical operation environment.
- If any serious incident that has occurred in relation to the device. Please report to the manufacturer and the competent authority of your area.
[The performance characteristics of the device]:
- Bacterial filtration efficiency (BEF), (%) ≥98%.
- Differential pressure (Pa/cm2) <40 Pa/cm2.
- Microbial cleanliness (cfu/g) ≤30cfu/g.(Meets EN14683:2019, Type II)
[Storage and transportation]:
- Storage: The packaged product should be stored in a dry, ventilated, non-corrosive gas place, away from fire sources and burning materials.
- Transportation: This product uses general transportation means, and it should be protected from violent impact, collision and rain and snow splash during transportation.
[Shelf life]:
- 2 year. See sales package for the production date and expiration date of the product.
[Applicable technical standards]:
- EN 14683:2019+AC Medical face masks - Requirements and test methods.