AusMed Health supplies Australian made surgical face masks, listed on the Therapeutic Goods Administration (TGA) register. AusMed Health is a registered member of the Sedex international ethical registry.
AusMed Health supply Level 3 masks tested to AS 4381:2015. Our 4 x ply masks are made with an ultra-soft, non-reactive inner layer to maximise facial comfort. Our automated process of manufacturing ensures minimum human intervention. We strictly test each batch to ensure consistency. Material selection combined with ultrasonic sealing ensures comfort and performance for the user. Our standard of manufacturing ensures the highest level of quality control for our customers.
Our surgical masks not only meet, but exceed the below standards for your peace of mind.
Summary of the Australian Standard for surgical face masks
Revised in December 2015 the standard AS 4381:2015 for face masks are now performance based on 3 tests:
- Bacterial Filtration Efficiency (BFE)
- Differential Pressure (Delta P)
- Synthetic Blood Penetration Resistance (Fluid resistance is measured mm Hg)
Masks are rated according to performance level 1, level 2 or level 3.
Level 1
Level 1 barrier medical face mask materials are evaluated for resistance to penetration by synthetic blood at the minimum velocity specified below, bacterial filtration efficiency and differential pressure. APPLICATIONS: For general purpose medical procedures, where the wearer is not at risk of blood or bodily fluid splash or to protect staff and/or the patient from droplet exposure to microorganisms (e.g. patient with upper respiratory tract infection visits GP)
Level 2
Level 2 barrier medical face mask materials are evaluated for resistance to penetration by synthetic blood at the middle velocity specified below, bacterial filtration efficiency and differential pressure. APPLICATIONS: For use in emergency departments, dentistry, changing dressings on small or healing wounds where minimal blood droplet exposure may possibly occur (e.g. endoscopy procedures)
Level 3
Level 3 barrier medical face mask materials are evaluated for resistance to penetration by synthetic blood at the maximum velocity specified below, bacterial filtration efficiency and differential pressure. APPLICATIONS: For all surgical procedures, major trauma first aid or in any area where the health care worker is at risk of blood or bodily fluid splash (e.g. orthopaedic, cardiovascular procedures)
Table of Characteristic Differences Between Level 1, 2, and 3 Masks
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(AS) 4381: 2015 SINGLE USE FACE MASKS |
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Characteristics |
Level 1 |
Level 2 |
Level 3 (highest) |
Test method |
|
Bacterial Filtration Efficiency (BFE) % |
≥ 95% |
≥ 98% |
≥ 98% |
ASTM F2101-14 or EN 14683:2014 |
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Particulate Filtration Efficiency (PFE) % (0.1 μm) |
Not Required |
Not Required |
Not Required |
N/A |
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Differential Pressure (Delta P) mm H2O/cm2 |
< 4.0 |
< 5.0 |
< 5.0 |
EN 14683:2014
|
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Resistance to penetration by synthetic blood (fluid resistance) min pressure in mm Hg for pass result |
80mm Hg |
120mm Hg |
160mm Hg |
ASTM F1862 / F1862M-13 or ISO 22609 |
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