All masks containing CIDALTEX® technology are medical devices that meet the associated standards established by the European Commission. For example, the IIR and FFP Medical CIDALTEXsurgical masks® comply with the European Directive 93/42/EEC and are certified to standards EN 14683:2019-AC:2019. This certification ensures the level of protection for droplets, the level of bacterial filtration (reference size 3.0um) and the microbial cleanliness of the masks.
FFP-grade masks offer an additional level of protection based on the higher standard EN 149:2001-A1:2009 for PPE (Individual Protection Equipment) such as FFP2 masks. Tests conducted according to this standard ensure the filtration level of liquid and solid aerosols (reference size 0.6um) of masks, as well as the effectiveness of their special anti-leak form.
Surgical masks are intended to prevent the projection into the environment of droplets emitted by the subject wearing the mask. They also protect the wearer from droplet sprays emitted by a person nearby when talking, coughing or sneezing. On the other hand, although the outer layer is resistant to splashing, these masks are less effective against inhaling very small airborne particles.
The CIDALTEX® masks (surgical type IIR and grade FFP2)filter more than 98% of bacteria (reference size 3.0 m),and resistsplashing. They are also produced at a high level of cleanliness (microbial cleanliness; 30 UFC/g).
CIDALTEX FFP Medical masks are medical devices that offer an additional level of protection. They are intended to protect the wearer from inhaling droplets and solid and liquid particles suspended in the air. This type of mask is more restrictive compared to surgical masks and can cause discomfort and respiratory discomfort.
They filter more than 94% of the medium-sized aerosols 0.6 m. Finally, their shape is optimized for limited leakage (total inward leakage).
The addition of CIDALTEX ® technology to the filter layer allows the decontamination of the inspired and exhaled air by interacting with the infectious agents entering the mask that are eliminated in contact with the broad-field active ingredient attached to the layer. This technology greatly enhances the wearer’s level of protection by eliminating infectious agents deposited or filtered by the mask, and allows two simultaneous actions: filtration and decontamination.
It is advisable to use CIDALTEXmasks ® in medium- or high-probability locations of a virus in the air: public transport, enclosed spaces, shops, health facilities, health professionals, contact with a contaminated patient, andc.
Wearing the mask:
- Wash your hands thoroughly before touching the mask
- Use elastics to manipulate masks
- Adjust the mask with elastics and nasal bars until it forms as much watertight a seal around the face as possible. Make sure the mask is properly positioned.
If the mask is damaged, interferes with breathing, appears moist, is contaminated with one or more bodily fluids or other infectious elements: the mask must be discarded and replaced with a new one.
- Wash your hands before touching the mask
- Remove the mask by the elastics
- Throw the mask and then close the bag
- Washing your hands after removing the mask
The recommended wearing time for IIR and FFP CIDALTEX surgical masks® is a maximum of 4 hours. Indeed, as with the usual masks, the humidification of the mask by breathing alters the qualities of the mask and decreases the efficiency regarding filtration.
The IIR and FFP surgical masks can only be used once.
No, the extra decontaminating layer does not increase breathing difficulties. It is a little more difficult to breathe with an FFP mask than a surgical mask because it is more airtight.
CIDALTEX grade FFP masks are 20% more breathable than the breathability threshold set for FFP2 masks (EN 149 standard).
To say that the viruses and bacteria tested are representative of the vast majority of viruses and bacteria; and recognized as such.
The active ingredient in the mask’s polymers is Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC), an antibacterial agent that also has properties against viruses and fungi.
This antibacterial agent is known and already used in other pharmaceutical products such as antiseptic skin solutions or wipes. He’s a reliable agent.
With the usual masks, the pathogens remain stuck in the filter layer and the mask is then contaminated for several days. This fraction of pathogens retained by the classic mask remains fully functional and can then pass through the mask to the wearer’s face. This innovation allows CIDALTEX ® to bring a double action to our masks. There is an extra layer that can inactivate infectious agents. They are then trapped by the mesh of the fibres, then come into contact with ADBAC and die, which limits the risk of damage to the wearer’s face and thus the risk of contamination.
ADBAC’s anti-bacterial and anti-viral actions are well established and documented. Our laboratory partners have proven that ADBAC attached to polypropylene fibers retains its full disinfectant potential. It allows a bacterial reduction of 99.99% (4 log pathogenic reduction) on gram-positive and gram-negative bacteria (S. aureus and E. coli). In addition, a viral inactivation efficacy of 99.96% was demonstrated on coronavirus (HCoV-229E) after only 20 minutes of contact, half the recommended duration of use.
The risk associated with the use of ADBAC is very limited. We have selected a grafting process known for its reliability: the fixation of cyclodextrin molecules on polypropylene fibers. Thus, ADBAC molecules are retained with a very strong affinity in these fibers which ensures a decontaminating agent fixation in the middle layer. In addition, the decontaminating layer is completely insulated between the inner and outer layers of the propylene fibers, and thus prevents direct contact with the user.
To validate this protection, we conducted studies of decontaminating agent leaks by simulating human breathing by cycles of air inhalation passing through masks. After a period of 4 hours, the recommended total duration of port, no trace of ADBAC was found in any layer except the one treated. This demonstrates the strong fixation of the agent on the functional layer of the mask, allowing no ADBAC molecule to escape.
The decontaminating agent contained in the functional layer cannot be found outside the mask under normal conditions of use, avoiding any contact between the skin and the decontaminating agent.
The wearing of CIDALTEX masks is strongly discouraged for people with a known allergy to benzalkonium chlorides. The materials that make up the masks are guaranteed to be latex-free.
Like any medical mask, it is recommended to keep CIDALTEX® masks away from moisture, dust and direct sunlight. They can withstand normal storage temperatures (5c -40C). Finally, it is best to keep them in their plastic packaging before use to avoid contamination.
CIDALTEX® masks have a shelf life of 5 years.
It is important to properly shape the nasal bar of the masks before they are used. On most faces, it is best to flatten the nasal bar and give it a rounded shape before use.
If the leaks are still present, tighten the elastics by making a small knot in each of them. This will have the effect of placing the mask against your face and preventing leaks.
If significant leaks persist, your morphology may not be suitable for this form of mask. We advise you to let us know your situation and change your reference.
For maximum protection (optimal filtration and minimal leakage level), it is normal for the elastics in your mask to be stretched to place the mask against your face. If the discomfort is too great, we encourage you to use a bar to hold the elastics at the back of the head.