Frequently Asked Questions

01. 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 fittingTight 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 resistanceTested to be fluid resistant
For healthcare settingFor 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.
* FDA – Food and Drug Administration
* NIOSH – National Institute for Occupational Safety and Health

02. Applicable standards:

ISO 9001:2015 Quality Management System
ISO 13485 Medical devices – Quality Management System

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

03. Terms and Definitions

Measure how efficient the mask is able to filtrate against bacteria
Presented in percentage of bacteria larget than 3 microns filtered out by
the mask
Minimum requirement = 95%

Measure how efficient the mask is able to filtrate against small particles
Presented in percentage of particles larger than 1 micro filtered out by the
mask
Minimum requirement = 95%

Evaluate the resistance of the mask to penetration by a small volume of
synthetic blood at high velocity (80mmHg, 120mmHg).
Pass/fail based on visual evidence of synthetic blood penetration
Minimum requirement = 80 mmHg (N95 and 3-ply masks)
Can go up to 120mmHg for 3-ply surgical mask
Higher value → better resistance

Measure how air is easily passed from one side of the mask to the other.
Indicate how easily the wearer can breathe through the mask.
Higher value → more difficult to push the air through (Higher breathing
resistance) → Lower breathability (less comfortable), but better air
filtration

Determine the time of flame spread for the mask material
Minimum requirement = Class 1 flammability (exhibit normal
flammability)