Filtration Performance of FDA-Cleared Surgical Masks

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There are two main indicators of the filtration performance of surgical masks: bacterial filtration rate (BFE%) and particle filtration rate (PFE%).

 

1. Bacterial filtration rate (BFE %)

Refers to the filtration efficiency of the mask for bacteria with a diameter of 3um or more.

The mask samples are professionally tested under the ASTM F2101-19 standard. By comparing the control count of aerosolized Staphylococcus aureus (about 3um in diameter) upstream of the mask sample with the count of Staphylococcus measured downstream to determine the blocking effect of the sample on cocci, the bacterial filtration efficiency of the tested sample is obtained.

 

2. Particle filtration rate (PFE %)

Refers to the filtering efficiency of the mask for non-oily particles with a diameter of more than 0.1um.

Under the requirements of ASTM F2299, the mask samples are professionally tested. Use a laser particle counter to count the latex particles (about 0.1um in diameter) that pass through the sample within one minute, compare the average throughput of particles in one minute when there is no sample obstruction, and get the number of particles penetrating the sample, thereby obtaining the sample mask particle filtration rate.

 surgical mask

The FDA approved surgical masks are divided into 3 levels: Level 1, Level 2, Level 3.

 

The main performance differences of the three levels of masks are as follows:

Performance

Level 1

Level 2

Level 3

Bacterial Filtration Efficiency
(BFE %)

≥95

≥98

≥98

Particle Filtration Efficiency
(PFE %)

≥95

≥98

≥98

Synthetic Blood
Penetration Resistance

80 mmHg

120 mmHg

160 mmHg

Differential Pressure
(Delta P)

<5.0 mm H2O/cm2

<6.0 mm H2O/cm2

<6.0 mm H2O/cm2

 

It can be seen that different grades of surgical masks have different requirements for BFE and PFE, and the filtration efficiency requires specific experimental methods to be known. Therefore, to choose a qualified surgical mask, the mask supplier needs to provide an internationally recognized profession. The test report is used to prove that the supplier is indeed capable of providing medical masks.

 

Are you looking for a surgical mask supplier?

Founded in 2006, Wellmien has grown to a company specializing in disposable medical supplies and Personal Protection Equipment (PPE), integrating with design, manufacture and sales capacity. Our sales headquarter is in Suzhou, Jiangsu and manufacturing plants cover a total area of 8,000m2 including 1,500m2 of clean room.

Wellmien provides globally medical care and food processing facilities with products including surgical masks, gowns, coveralls, aprons, bouffant caps, shoe covers, sleeve covers, under pads, disposable gloves, wound-care products, first-aid products and surgical packs etc. Our products are best sold to worldwide markets and widely applied to different settings such as hospitals, care centers, wholesalers, government agencies or institutes, food industries and households, etc. With excellent OEM services, our annual sales exceed 20 million USD.

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