Surgical face mask with high bacteria filtration and extream low breath resistance, comfortable for user. Suitable for normal surgery/procedure in hospital and clinic.
The face mask is latex free and use brand new hypoallergenic material, odourless and lint free.
Popularize the common sense of mask use.
Masks are basically divided into three categories on the market:
1. Civil USE
2. Medical USE
3. Medical surgery USE
1. Civil use:
the first type of non disinfected disposable mask has an anti-virus rate of 0%.
The second type of sterilized mask is called disposable sterile mask, with an anti-virus rate of 45%.
The third is N95 anti-virus rate 95%.
2. Medical USE
The anti-virus rate of disposable medical mask is 85%.
3. Medical surgery USE
Anti virus rate of medical surgery 95%.
Surgical mask is a recognized product for cross infection in operating room.
Use a mask with a low isolation rate if the user is infected
Disposable Medical Surgery USE
3 PLY Face Mask
3. Medical surgery USE
Anti virus rate of medical surgery 95%.
Surgical mask is a recognized product for cross infection in operating room.
Specifications:
1. Product model / specification and division description
1.1 structure and composition
Disposable surgical mask (hereinafter referred to as: mask) is composed of surface layer, middle layer, bottom layer, mask belt and nose clip.
1.2 model and specification
According to the clinical needs, the design style of the mask is plane ear hanging type, the specification is: 17.5cm × 9.5cm
| Specification |
length |
width |
Expand width |
Length of single mask belt (1 on each side) |
| 17.5cm×9.5cm |
17.5cm |
9.5cm |
17.0cm |
17.0cm |
1.3 material composition
The surface material is sanitary polypropylene imitation adhesive cloth, the middle material is high-efficiency filter melt blown cloth made by polypropylene spray wire method, the bottom material is sanitary polypropylene imitation adhesive cloth, the mask belt is knitted by polyester thread and a small amount of spandex thread, and the nose clip is made of bendable and set polypropylene.
2. Performance index
2.1 appearance
The appearance of the mask shall be clean, in good shape, and the surface shall be free of damage and stain.
2.2 structure and size
2.2.1 after wearing the mask, it shall be able to cover the mouth, nose and jaw of the wearer.
2.2.2 the specification and size shall meet the requirements of Table 1, and the maximum error shall not exceed ± 5%.
2.3 nose clip
2.3.1 the mask shall be equipped with a nose clip made of plastic material.
2.3.2 the length of nose clamp shall not be less than 8.0cm.
2.4 mask belt
2.4.1 the mask belt shall be easy to wear and take.
2.4.2 the breaking strength of the connection point between each mask belt and the mask body shall not be less than 10N.
2.5 synthetic blood penetration
When 2ml synthetic blood is sprayed to the outer side of the mask at 16.0kpa (120mmhg), the inner side of the mask should not be penetrated.
2.6 filtration efficiency
2.6.1 bacterial filtration efficiency (BFE)
The bacterial filtration efficiency of the mask shall not be less than 95%.
2.6.2 particle filtration efficiency (PFE)
The filtering efficiency of mask for non oil particles shall not be less than 30%.
2.7 pressure difference (Δ P)
The pressure difference Δ p between the two sides of the mask for gas exchange shall not be greater than 49pa / cm2.
2.8 fire resistance
The material of respirator shall be non combustible, and the burning time of respirator after leaving the flame shall not be more than 5S.
2.9 ethylene oxide residue
If ethylene oxide is used for sterilization, the residual amount of ethylene oxide shall not exceed 10 μ g / g.
2.10 asepsis
Masks should be sterile.
3. Inspection method
3.1 appearance
Take 3 masks randomly, and check the normal or corrected vision, which should meet the requirements of 2.1.
3.2 structure and size
3.2.1 take 3 masks at random and wear them for verification. The results shall meet the requirements of 2.2.1.
3.2.1 measure with general or special measuring tools, and the results shall meet the requirements of 2.2.2.
3.3 nose clip
3.3.1 take 3 masks at random, check the nose clip material and bend it by hand, all of which shall meet the requirements of 2.3.1.
3.3.2 take three masks at random, take out nose clip, and measure with general or special measuring tools, all of which shall meet the requirements of 2.3.2.
3.4 mask belt
3.4.1 take 3 masks at random, and check the adjustment condition through wearing, all of them shall meet the requirements of 2.4.1.
3.4.2 take 3 masks at random and measure with 10N static tension for 5S, all of which shall meet the requirements of 2.4.2.
3.5 synthetic blood penetration
3.5.1 number of samples: take 5 samples for test.
3.5.2 pretreatment conditions: the sample shall be pretreated in an environmental test chamber at 21 ºC± 5 ºC and 85% ± 5% relative humidity for at least 4 hours. Take the sample out of the environmental box for testing within 1min.
3.5.3 carry out the test according to YY / t0691-2008. See the appendix for the preparation method of synthetic blood. The results should meet the requirements of 2.5.
3.6 filtration efficiency
Three masks were randomly selected and tested according to the test method of bacterial filtration efficiency and particle filtration efficiency in yy0469-2011. The results should meet the requirements of 2.6.1 and 2.6.2.
3.7 pressure difference (Δ P)
Five samples were randomly selected for test according to the pressure difference test method in yy0469-2011, and the results should meet the requirements of 2.7.
3.8 fire resistance
Randomly select 3 samples for test, and conduct the test according to the flame retardant test method in yy0469-2011, and the results shall meet the requirements of 2.8.
3.9 ethylene oxide residue
The ethylene oxide residue shall be determined according to the method specified in GB / t14233.1-2008, and the gas chromatography with the limit extraction specified in Chapter IX shall be used as the arbitration method, and the result shall conform to the provisions of 2.9.
3.10 asepsis
The test was carried out according to the "direct inoculation method" in general rule 1101 "sterility test method" of Pharmacopoeia of the people's Republic of China (Vol. 4, 2015), and the results should meet the requirements of 2.10.
4 Terminology
Bacterial filtration efficiency (BFE)
The percentage of the mask material filtering the suspended particles containing bacteria under the specified flow rate.
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