European Certification Mask
Ethical, hygienic and healthy mask. (Allows you to smile and communicate more naturally)
Used in hospitals and public centres throughout Europe. (European Medical Device Conformity Certification 93/42/EC.)
The AllegraMask® MED is a medical face mask or medical hygiene mask that protects the mouth, nose and chin area.
This is a medical device within the meaning of EU Directive 93/42/EEC, as it reduces the transmission of pathogens by means of secretion droplets to other persons and thus reduces the risk of droplet infection (protection). It also reduces the risk of infection by transmission of bacteria and viruses through swab infection, which can be transmitted by touching the area of the nose, mouth and chin (self-protection).
The AllegraMask® MED is also suitable for all persons who cannot wear a so-called surgical mask for medical or other valid reasons.
The AllegraMask® MED is worn like a pair of glasses and has a protective shield covering the mouth, nose and chin area. Like visors or face shields, the bottom and sides are split, making them air permeable and therefore have no filter properties.
According to the 14971 risk analysis, there are no unacceptable risks. See the ISO 14971 risk management report from July 2020. There are no application risks, no biocompatibility risks, and no residual risks of transmission of infectious diseases by infectious droplets. Equivalent to all medical mouth-nose masks (such as FPP 1, 2, 3).
The State Health Office of Mecklenburg-Western Pomerania has approved and approved the visors, which are even worn by virologists and bacteriologists at the University Hospital Rostock, as an alternative (not as a supplement!) to the cloth mask.
The AllegraMask® MED mask has been developed based on this. It is supposed to contribute to reducing (or even preventing) the risk of infection by viruses, bacteria and fungicides through droplet transfer but also through infection transfer from swabs. According to the definition, it is therefore a medical device.
The AllegraMask® MED is an oral and nasal protector for the reduction and prevention of pathogens in third parties that are transmitted by droplet infections. Similar to established medical masks from the SPM, a reduction in the transmission of bacteria and viruses occurs. Similar to medical masks from the SPM, where medical efficacy cannot be fully proven, the AllegraMask® MED is similar. The medical efficacy with regard to the avoidance and prevention of infections by means of so-called droplet infection cannot be fully proven. The reduction of the number of droplets (aerosols) that escape and are transmitted.
Thus, the AllegraMask® MED Mask develops a medical protective effect and should therefore be considered in public areas as a so-called community mask, as a medical device equivalent to medically established SNP class I masks (FPP masks).
Wearing the AllegraMask® MED also reduces the transmission of viral and bacterial infections through constant contact with the face and especially the mouth and nose areas, and can therefore have a medical effect.
According to the definition of "medical device" in EU Directive 93/42/EEC, "medical device" means any instrument, apparatus, device, equipment, software, material or other article, used alone or in combination, including any device specifically designed by the manufacturer to be used for diagnostic and/or therapeutic software intended and used for the proper functioning of the medical device and intended by the manufacturer to be used in human applications for the following purposes:
- Detection, prevention, surveillance, treatment or alleviation of diseases.
- Detection, monitoring, treatment, alleviation or compensation for injuries or disabilities.
- Examination, replacement or modification of the anatomical structure or a physiological process.
- Regulation of conception.
The AllegraMask® MED is a product that contributes to disease prevention in its mode of action and areas of application, excluding contraindications. In the entire literature, there is no definitive scientific definition and statement that diseases are actually prevented and avoided by wearing a SNP mask - not even with so-called FPP 1, 2, 3 medical masks. Nevertheless, the AllegraMask® MED SNP mask should be considered equivalent to classic SNP medical masks, since the transmission of macro- and microbiological aerosols (droplets) is greatly reduced.
The Bavarian Ministry of Health has also commented on the use of the AllegraMask (as a representative of the mask type) for the containment of the coronavirus pandemic.
EUROPEAN CERTIFICATION 93/42 CE AllegraMask® is a Medical Device under the EUROPEAN CERTIFICATE OF DECLARATION OF CONFORMITY and corresponds to the classification according to Class (I), Standard 1 and the basic requirements of Directive 93/42/EEC on Medical Devices according to Annex 1, taking into account the changes made by Directive 2007/47/EC.
EUROPEAN PPE CERTIFICATION AllegraMask® is a PPE under the EUROPEAN DECLARATION OF CONFORMITY CERTIFICATE as it is classified in accordance with Annex (I), Category I and the basic requirements of Regulation (EU) 2016/425 on Personal Protective Equipment according to Annex (II). The technical documents pertaining to the product have been prepared in accordance with Regulation (EU) 2016/425 according to Annex (III) Technical Documentation for PPE.
The manufacturer undertakes to provide the documents relevant to the product and to send them electronically upon justified request.
- IT HAS CERTIFICATION 13845/2016: DISTRIBUTION OF MEDICAL PERSONAL PROTECT MASK
- IT HAS THE ISO 9001 CERTIFICATION IT HAS THE FSYS IATF CERTIFICATION
ITS BENEFITS ARE MANY:
- High degree of comfort.
- It can be used continuously, without uncomfortable pressure points, it is transparent and does not give you the feeling of lack of air.
- There are no uncomfortable pressure points and you can see your entire face.
- It is an essential tool for communicating with people with hearing disabilities.
- Created with an attractive design with interchangeable temple color options.
- Cleaning and Disinfection: Clean or disinfect the mask after each use. When changing patients, the mask should be disinfected. \nWash all parts in warm water with a soap solution or alkaline detergent; then rinse under warm running water to remove any residue. Hard brushes, abrasives or other materials that may damage surfaces should not be used.
- Disinfection: All parts made of PVC, silicone or polycarbonate can be disinfected using commercially available disinfectants that are suitable for plastic materials. The manufacturer's information on exposure times and application concentrations of the disinfectants must be followed. Also observe the manufacturer's safety instructions for the disinfectant. Flame retardant and non-toxic.
- Environmentally friendly due to its long life as it is 100% recyclable.
- Super comfortable and lightweight with a weight of (51 gr)
- It is worn like glasses, without the feeling of suffocation like traditional masks, and can be worn comfortably with your glasses without any problem.