FDA vouches for locally manufactured face masks

The Food and Drugs Authority (FDA) has equated locally manufactured face masks to internationally accepted N-95 masks for use by health workers.

In a write-up, the FDA said a head-to-head comparison of the locally manufactured masks using the American Society for Testing of Materials (ASTM) methods proved that they are equivalent to the N-95 masks.

LOCALLY MADE MEDICAL FACE MASKS (Equivalent to N-95 Face Mask)

Specification:

In accordance with Public Available Specifications (GS PAS 4:2020) and FDA requirements for registration of locally made Face Masks.

Description:

Three-layered Face mask ie. a two-layer fabric with a hard stiff in between.

Material:

Plain fabric which is bleached to ensure the removal of starch to avoid coagulation for easy breathability.

Dimensions:

Length – Cheek to Cheek (200mm -250mm) Width – Above the Nose to bottom of the Chin (90mm – 150mm)

Thickness Test:

When measured with the digital thickness gauge,the thickness should not be less than 0.85mm.

Porosity Test:

The ability of the mask to create a barrier to viruses, bacteria and germs, but also enables easy breathability as air easily passes through.

Breathability Test:

Ability of persons wearing the mask to breathe without difficulty.

Aerosol Splash Test:

Ability of the mask to protect the wearer from oropharyngeal secretions and vice versa thus preventing the spread of viruses. The Aerosol used for the Aerosol Splash Test has less viscosity than blood and oropharyngeal secretions.

Results of Tested Medical Masks:

Thickness of registered imported N-95 range between 0.85mm – 1.4mm and that of locally made medical masks range between 1.0mm – 1.34mm, which comply with the standard of not less than 0.85mm.

Tests of the locally made medical face masks were compared head-to-head with the N95 using the American Society for Testing of Materials (ASTM) Methods

FDA Medical Device ISO 17025 -2017 Accredited Laboratory