1. Differences between surgical masks, N95 respirators and surgical N95 respirators
| Surgical Mask | N95 Respirator | Surgical N95 Respirator |
| Helps to protect the wearer from large-particles droplets of blood or body fluids which may contain germs (virus and bacteria). | Help to reduce exposure to very small airborne particles or contaminants. | Helps to protect wearer from large droplets of blood or body fluids and very small particles/fine aerosolised droplets (from cough). |
| US FDA cleared –510 (k) approval number | NIOSH approved – TC approval number | US FDA cleared – 510 (k) approval number NIOSH approved – TC approval number |
| Loose fitting | Tight fit – Form a seal around the nose and mouth | Tight fit – Form a seal around the nose and mouth |
| Bacterial filtration efficiency (BFE) above 95% | Particulate filtration efficiency (PFE) – minimum 95% against particulate matter (0.3 microns in size) free of oil | Particulate filtration efficiency (PFE) – minimum 95% against particulate matter (0.3 microns in size) free of oil |
| Fluid resistant (Resistant to penetration of body fluid) | Not tested for fluid resistance | Tested to be fluid resistant |
| For healthcare setting | For industrial use (e.g. construction worker) where workers are exposed to dust and small particles During haze seasons | For healthcare setting –To protect both patients and health care personnel from the transfer of microorganisms, body fluids and particulate matter. |
* NIOSH – National Institute for Occupational Safety and Health
2. Applicable standards:
Manufacturing Facilities – To ensure good quality management system
ISO 9001:2015 Quality Management System
ISO 13485 Medical devices – Quality Management System
Standard Specification for Performance of Materials used in Medical Face Masks
ASTM F2100-19 – Test mask material on bacterial filtration efficiency, differential pressure, particulate filtration efficiency, resistance to penetration by synthetic blood and flammability. Assign a numerical rating for the barrier performance of the material:
Level 1 – for low risk of fluid exposure
Level 2 – for moderate risk of fluid exposure (Pasture 3-ply earloop surgical mask)
Level 3 – for high risk of fluid exposure
Reference: Nelson Labs Medical Face Mask Tests and Requirements –
https://www.nelsonlabs.com/wp-content/uploads/2020/03/Face-Mask-Testing-Requirements.pdf
3. Terms and Definitions:
| Terms | Definitions | ||||||||||||
| PM 2.5 | PM stands for particulate matter which is a mixture of solid particles and liquid droplets found in the air such as dust, dirt or smoke. PM 2.5 are fine particles with diameter less than 2.5 micrometers, which are inhalable and thus detrimental to human health. | ||||||||||||
| Bacterial filtration efficiency (BFE) |
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| Particulate filtration efficiency (PFE) |
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| Synthetic blood penetration for liquid barriers (i.e Fluid resistance) |
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| Differential Pressure (DP) (i.e Breathability) |
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| Flammability |
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