Disposable mask, what are we talking about?
Feature of an FFP disposable respirator mask
FFP masks (Filtering Face Piece particles) are personal protective equipment (PPE = respiratory protection devices) subject to certain standards as well as to efficacy tests .
These masks serve primarily as protection against fine particles .
Their efficiency is evaluated according to the filtration rate but also according to the rate of leakage towards the interior.
The 2001 version of standard EN 149 defines 3 efficiency classes for this PPE, namely
FFP1 N RD, FFP2 N RD, FFP3 N RD.
The “cleanliness” of a medical mask, before its use, is defined by the quantity of viable microorganisms present on the mask (value expressed in colony-forming units-CFU).
The EN 14683: 2014 standard provides the test protocol to be followed for the recovery and enumeration of bacteria and fungi, and it refers to the obligation to validate the test method on each composition of
mask, according to standard EN ISO 11737-1. This microbial load must not exceed 30 CFU per gram of mask tested. This standard EN14683 is the standard used for surgical type 3-ply masks.
We manufacture our medical masks in France in an ISO 7 classified clean room . This makes it possible to constantly ensure the microbial cleanliness of our products and to guarantee our customers their immediate operationality.
Requirements of the main tests on the FFP mask:
The first criterion is the filtration efficiency of the particles.
The disposable mask FFP1 must meet an efficiency of 80%
The FFP2 disposable mask must meet an efficiency of 96%
FFP3 disposable mask must meet 99% efficiency
Respiratory resistance FFP mask also called the Delta P:
On inspiration (30 liters / minute): FFP1 = 0.6 FFP2 = 0.7 FFP3 = 1
On inspiration (95 liters / minute): FFP1 = 2.1 FFP2 = 2.4 FFP3 = 3
On inspiration (160 liters / minute): FFP1 = 3 FFP2 = 3 FFP3 = 3
These masks can also be tested to determine their total inward leakage, based on their filtration level.
The cases of influenza and Ebola pandemics
The FFP2 and FFP3 masks are also available with valve, to protect the wearer against the risk of inhaling small particles suspended in the air, which could contain the virus.
The use of a mask with valve also gives more breathing comfort for the user.
These masks also protect against droplets emitted by a person with the flu, for example.
Using masks
1 -Place the mask on the face, the nose clip on the nose.
2 -Pass the elastics behind the head while holding the mask, without crossing them.
3 - Pinch the nose clip with both hands to adjust it to the level of the nose.
4 -Check that the mask is on correctly.
Manufacturing standards
Our range of FFP1, FFP2 and FFP3 masks with or without valve are manufactured under an ISO 9001 & EN ISO 13485 certified system and comply with the requirements of European Directive 89/686 / EEC and with standard EN 149: 2001 + A1: 2009 .
Our FFP masks are made in France.
An FFP2 mask is part of protection category III.
Assessment of initial microbial contamination according to standards EN 14683: 2014 & NF EN 11737: 2006 Additional microbiological controls: ASR, E.Coli, Staphyloccocci, on request
Type II and type IIR disposable face masks Kolmi
Complies with the European standard on medical masks EN 14683: 2019
SofSkin technology presents a very advanced filtration system.
This innovation thus allows:
• Optimal performance of our masks throughout the duration of the interventions
• A guarantee of the excellent breathability of the mask during use (Delta P)
• Exceptional comfort in contact with the skin thanks to our very high performance materials
• Very high moisture absorption inside the mask while maintaining its exceptional breathability.
Softskin Type IIR masks resistant to splashes of body fluids
This range of surgical masks is recommended for risky medical examinations and / or surgical procedures. Our masks are also made of non-woven materials that are very resistant to projected, sprayed or airborne fluids.
Normaskin Kolmi Type II Strap Masks
Complies with the European standard on medical masks EN 14683: 2019
This range offers:
• Excellent comfort and breathability (Delta P)
• Excellent bacterial filtration efficiency greater than 98.6% (EFB)
• Non pre-contamination of masks according to EN ISO 11737-1 (bioburden)
Reusable washable mask
The reusable washable mask must meet the Afnor Spec S76-001: 2020 specification.
There are therefore two categories of filtration:
- Category 2 with filtration ranging from 70% to 90% - This mask is now prohibited -
- Category 1 whose filtration is greater than 90%
As a reminder, a 3-ply surgical mask within the meaning of standard EN14683 must filter at more than 95% and more than 98% for IIR types.