Surgical mask definition and manufacturing
The mask protects the environment from pathogens carried by droplets emitted from the wearer's mouth and nose.
It protects the healthcare professional from splashes of potentially contaminated biological fluids (Type IIR qualification).
It must therefore have a dual function during inspiration and expiration with a standardized filtration quality in both directions.
Our range of surgical and FFP2 masks are manufactured in France under the Kolmi brand, which is now part of the global Medicom group. Kolmi remains a key reference in the world of short-term protective masks, with its high-performance industrial tools and unrivaled product quality on the market. Asian competition exists, but sometimes with products whose quality remains improvable and inconsistent given the countless offers and supply chains.
Voussert has therefore chosen to only offer masks made in France through its historic partnership with the Kolmi brand.
This guide will help you better understand the issues, the standards and understand the real differentiation of Kolmi quality.
Why choose a surgical mask made in France?
Soft materials: The Kolmi surgical mask range offers exceptional comfort for users with sensitive skin. Its cellulose-based inner layer prevents irritation due to contact and friction of the mask on the skin. These masks offer unparalleled comfort for
wearers with sensitive skin. The face piece, ear elastics, transverse elastics, and straps are made of soft materials . To complete this comfort, these masks are guaranteed latex-free .
Exceptional breathability: The masks are designed to provide excellent breathability and exceptional comfort in everyday wear. Their results exceed the requirements of the EN 14683 standard.
Integrated nose bar: The integrated nose bar allows our masks to adapt perfectly to various facial shapes.
Origami Kolmi Folding: Omega-shaped folding allows the mask to pre-form to the face
of the wearer. The fold also ensures the mask fits well and is comfortable on the wearer.
The Kolmi Smile: The Kolmi® Smile was created to help the mask fit comfortably on all face shapes, improving breathability.
Update on regulations on medical masks
EN 14683:2019+AC:2019 - Requirements
It defines the performance requirements for masks for medical use, taking into account different
criteria that guarantee the quality of the mask and safety for the wearer's environment:
- Bacterial filtration efficiency (BFE)
- Breathability (Delta P)
- Resistance to projections of biological fluids (Type IIR only)
- Biocompatibility
- Microbial cleanliness (Bioburden)
Additional tests not required by EN 14683
To ensure additional protection for its users, Kolmi masks are tested against viruses and submicron particles through two tests:
- Virus filtration efficiency (VFE)
- 0.1 µm particle filtration efficiency (EFP)
FFP protective mask definition and manufacture
A respirator is a Category III Personal Protective Equipment (PPE) that covers the mouth, nose, and chin. Also known as FFP masks (Filtering FacePiece), they protect the wearer from inhaling airborne droplets and particles that carry infectious agents.
id="Anchor6"The role and classification of the FFP protective mask:
-> It protects the wearer from airborne particles.
-> There are 3 levels of airborne particle filtration efficiency.
-> Standard EN 149:2001+A1:2009
-> EU Regulation 2016/425
The filtration of FFP masks is defined as follows:
| Kind | FFP1 | FFP2 | FFP3 |
| Filtration | 80% | 94% | 99% |
Tests for qualifying an FFP mask
| Total Inward Leakage Test - Maximum Leak Rate |
| * | ** |
| FFP1 | < 22% | < 25% |
| FFP2 | < 8% | < 11% |
| FFP3 | < 2% | < 5% |
| This test measures leakage inside the mask from the filter media valve seal. |
* results for at least 8 of the 10 arithmetic means relating to each carrier
** results for at least 46 of the 50 individual exercise results
| Filter material penetration test |
| Kind | Sodium chloride test 95 L/min | Paraffin oil test 95 L/min |
| FFP1 | < 20% | < 20% |
| FFP2 | < 6% | < 6% |
| FFP3 | < 1% | < 1% |
| This test measures the % of solid or liquid particles that penetrate the mask. |
| Breathing resistance test |
| Inspiration | Expiry |
| Kind | 30 L/MIN | 95 L/MIN | 160 L/MIN |
| FFP1 | < 0.6 | < 2.1 | < 3 |
| FFP2 | < 0.7 | < 2.4 | < 3 |
| FFP3 | < 1 | < 3 | < 3 |
| This test measures the maximum permissible resistance (mbar) |
According to current recommendations and in order to obtain the best seal and comfort for the user, the Kolmi FFP2 mask is available in 3 sizes (S, M and L).
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