Disposable mask

Characteristics of a disposable FFP surgical respiratory mask

FFP (Filtering Face Piece particles) surgical masks are personal protective equipment (PPE = respiratory protection devices) subject to certain standards and effectiveness tests . These masks are mainly used for protection against fine particles .
The effectiveness of an FFP or surgical mask is assessed based on the filtration rate but also on the inward leakage rate. The 2001 version of the EN 149 standard defines 3 effectiveness classes for this PPE, namely FFP1 N RD, FFP2 N RD, FFP3 N RD.

Standards for surgical masks and disposable FFP1 - FFP2 - FFP3 masks

The "cleanliness" of a medical surgical mask , before 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 mask composition, according to the EN ISO 11737-1 standard. This microbial load must not exceed 30 CFU per gram of mask tested. This EN14683 standard is the standard used for 3-ply surgical type masks.
We manufacture our medical surgical masks in France in an ISO 7 classified clean room . This ensures the permanent microbial cleanliness of our products and guarantees our customers their immediate operational readiness.

Requirement for disposable masks FFP1 - FFP2 - FFP3

Requirements of the main tests on the FFP mask:
The first criterion is the efficiency of particle filtration.
The disposable FFP1 mask must meet an efficiency of 80%
The disposable FFP2 mask must meet an efficiency of 96%
The disposable FFP3 mask must meet an efficiency of 99%

FFP mask breathing resistance also called 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 / minutes): FFP1 = 3 FFP2 = 3 FFP3 = 3
These masks can also be tested to determine their total inward leakage, based on their filtration level.

Disposable surgical mask with type II and type IIR straps   Kolmi

Compliant with the European standard for medical masks for surgical use EN 14683 : 2019
SofSkin technology features a highly advanced filtration system.
This innovation thus allows:
• Optimal performance of our masks throughout surgical procedures
• A guarantee of 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 disposable surgical mask resistant to biological fluid splashes
This range of surgical masks is recommended for high-risk medical examinations and/or surgical procedures. Our masks are also made of non-woven materials that are highly resistant to projected, sprayed, or airborne fluids.

Normaskin Kolmi Type II Disposable Surgical Mask with Straps
Complies with the European standard for surgical masks EN 14683:2019
This range of surgical masks offers:
• Excellent comfort and breathability (Delta P)
• Excellent bacterial filtration efficiency greater than 98.6% (EFB)
• No pre-contamination of masks according to standard EN ISO 11737-1 (bioburden)

The cases of the influenza and Ebola pandemics

FFP2 and FFP3 masks are also available with a valve, which protects the wearer from the risk of inhaling small airborne particles that could contain the virus.
Using a mask with a valve also provides greater breathing comfort for the user.
These masks also protect against droplets emitted by a person with the flu, for example.

Use of masks

1 - Place the mask on your face, with the nose clip on your nose.
2 - Pass the elastic bands behind your head while holding the mask, without crossing them.
3 - Pinch the nose bar with both hands to adjust it to the level of the nose.
4 - Check that the mask is properly fitted.

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 standard EN 149:2001+A1:2009.

Our FFP masks are made in France.
An FFP2 mask is part of protection category III.
Evaluation of initial microbial contamination according to EN 14683: 2014 & NF EN 11737: 2006 standards Additional microbiological controls: ASR, E.Coli, Staphylococci, on request

Reusable washable mask

The reusable washable mask must meet the Afnor Spec S76-001:2020 specification.
We then distinguish two categories of filtration:
- Category 2 with filtration of 70% to 90% - This mask is now prohibited -
- Category 1 with filtration greater than 90%
As a reminder, a 3-ply surgical mask as defined by standard EN14683 must filter more than 95% and more than 98% for type IIR.