[product name] surgical mask for medical use

Flat type

[gauge] binding type, ear hanging type

[structure and composition] made of nonwoven fabric or nonwoven composite material.It is divided into three layers, with plastic nose clip, and the mask belt can be elastic or inelastic, which has the characteristics of low airflow resistance, synthetic blood barrier, filtering particulate matter and bacteria, and flame retardant.

1) appearance: the appearance of the mask should be clean and in good shape, without any damage or stains on the surface.

2) structure and size: after wearing the mask, it should cover the wearer's nose, mouth and jaw.The design size and tolerance of the mask should meet the requirements.

3) the nose clip

3.1) the mask must be equipped with a nose clip, which is made of plastic material.

3.2) the length of the nasal clip should not be less than 8.0cm.

4) mask band

4.1) the mask belt should be easily worn.

4.2) the breaking strength at the connection point between each mask belt and the mask body should not be less than 10N.

5) penetration of synthetic blood: after 2ml of synthetic blood is sprayed to the outer side of the mask at a pressure of 16.0kPa (120mmHg), no penetration should occur on the inner side of the mask.

6) filtration efficiency

6.1 bacterial filtration efficiency (BFE) : the bacterial filtration efficiency of masks should not be less than 95%.

6.2) particle filtration efficiency (PFE) : the filtration efficiency of mask for non-oily particles should not be less than 30%.

7) pressure difference: the air exchange pressure difference between the two sides of the mask should be no more than 49Pa.

8) flame retardant: non-flammable materials should be used for mask materials.The mask should not burn more than 5s after leaving the flame.

9) sterile: the mask should be sterile.

10) ethylene oxide residue: for the mask sterilized with ethylene oxide, the residue of ethylene oxide should not exceed 10ug/g.

[scope of application] for clinical medical personnel to wear during invasive operation, covering the user's mouth, nose and jaw, to provide a physical barrier to prevent the direct passage of pathogens, microorganisms, body fluids and particles.

1) tear off the outer package, take out the surgical mask and use it as usual;

2) check whether the package is damaged or leaking;

3) destroy after use.

[production date] see the sealing of the packaging bag or the qualification certificate in the bag.

[model and specification] see the sealing of the packaging bag or the certificate of quality in the bag.

[sterilization date] see box body certificate.

[expiration date] see the sealing of the packaging bag or the certificate of conformity in the bag.

[matters needing attention, warnings and tips]

1) check the package before use. Do not use it if the package is damaged.

2) this product is sterile, sterilized by ethylene oxide, and has a valid period of two years.

3) this product is only for one-time use. After use, it is non-recyclable medical waste. Please treat it as such waste.

Contraindications: none.

[storage method] it should be stored in a ventilated, clean and cool place with relative humidity no more than 80%.Avoid fire source, toxic, volatile and corrosive

Item contact.

[transportation] conventional transportation, transportation should pay attention to moisture, rain and bump.

Attachment: the interpretation of the graphics, symbols, abbreviations and other contents of the medical devices used in this product

One-time use reading instructions batch number: no. : no. : no. : no. : no. : no. : no. : no. : no. : no. : no. : no.

[address] guandong, dingluan town, changyuan county

[after-sales service unit] xinxiang qiangsheng medical equipment co., LTD

[address] guandong, dingluan town, changyuan county

[production address] kanto, dingluan town, changyuan county

[fax: 0373-8962222] 0373-8962789

h.nqs@163.com

[specification preparation date] December 10, 2016