Quality system

It is recommended to change the mask as soon as it becomes noticeably wet. The recommended time for using the mask is 1 hour.

It is a room or a group of rooms with monitored environmental parameters , used for laboratory purposes or production using high purity materials. The cleanroom where our masks are produced meets the ISO 8 cleanliness criteria, which means a 10-fold reduction in the air’s number of potential pollutants. The production process of medical acts in our company meets all the ISO EN13485: 2016 standard requirements, which defines medical devices’ production standards.

Masks are packed in vacuum bags to ensure the preservation of their quality parameters and sterility. Then, vacuum bags are packed in sales boxes according to product types and sizes in the online store.

The purpose of face masks is to filter out dirt particles, liquids, and aerosols that could contribute to the virus’s spread over a distance. KN95 / N95 / FFP2 half masks are one of the protective measures recommended by the WHO and CDC against the COVID-19 pandemic. They help to protect people in our environment against the transmission of the virus through airborne droplets. However, they do not replace other forms of protection, e.g., regular hand washing, and should be used together with them. Using face masks as the only protection against COVID 19 does not protect you from contracting the virus.

BFE is a coefficient describing the effectiveness of bacterial filtration given in %. Depending on the type of mask, it ranges from 95% to 99%. The degree of filtration of individual products in our offer is each time provided for the product in the online store. The CDC recommended minimum filtration level for medical masks against the COVID-19 pandemic is 95%. All our products meet these criteria.

The mask type designation determines the effectiveness of the bacterial filter . Type I masks should have a filtration level above 95%. Type II shows above 98%, and type IIR should guarantee both filtration efficiency above 98% and increased resistance to liquids and aerosols (splash resistance), necessary for example, during surgical procedures.

Depending on the type of masks, they are intended both for everyday public use and in industries with higher standards of microbiological purity, such as hospitals, laboratories etc. Filtering half masks are designed especially for use in workplaces etc.

Our masks do not cause breathing problems when they are worn by healthy people. The materials from which the shows are made guarantee high breathability while filtering unwanted particles with a diameter of 0.3 microns and more. However, in people with diseases of the upper respiratory tract (respiratory failure, asthma), it is not recommended to use masks of any type.

Masks are recommended wherever there is a risk of transmission of infection by droplets and in places where others should be protected against particles exhaled by us with the air. Depending on the type of mask, they are intended both for everyday public use and in industries with higher microbiological purity standards, such as hospitals, laboratories etc.

The level of protection depends on the type of mask and the materials used in them. Depending on the product, our masks block from 94% (minimum standard FFP2) to up to 99% of particles with a diameter of 0.3 microns or more. This means the filtration of pollutants such as dust and dirt, as well as most biological pollutants. Detailed information is provided in the “Products” tab and for all items individually in the online store.

The mask layers touching the skin are made of spunbond fiber, Oeko-Tex certified, which ensures complete skin safety, does not cause allergic reactions or irritation. The mask’s outer layer is made also of hydrophobic nonwoven spunbond fabric, which provides the most significant resistance to liquid droplets and aerosols. The materials used in the inner layers of the masks depend on the specific model and include, for example, meltblown bacterial filters, hot air cotton filters, carbon filters. Detailed information is provided in the “Products” tab and for all items individually in the online store.

In the production process, all physical parameters of the mask and its components are tested, i.e., durability, stretchability of the ears, breathability, BFE filtration degree, resistance to liquids aerosols (e.g., in the case of an IIR mask). The nonwovens used in production are marked with Oeko-Tex quality certificates, which means that they have been tested for the presence of 100 of the most dangerous substances that threaten consumers, the presence of foreign odours, as well as resistance to sweat and saliva.

 The CDC and WHO recommended precautions in the face of the COVID-19 pandemic include masks made of materials that filter at least 94% of particles with a diameter of 0.3 microns and more splendid. All our products meet these conditions. The materials used by us ensure the masks’ maximum breathability. They can be used for everyday use by healthy people (people with upper respiratory tract diseases are not recommended to use any masks). The most popular in daily service will be our VS003 or VS004 masks.

The available types of product packages are shown in the online store. The amount of masks in a box is given for every individual product.

The ISO standard means a set of generally recognized conditions met by companies producing medical devices . The cleanroom where our masks are made meets the ISO 8 cleanliness criteria, which means a 10-fold reduction in the air’s number of potential pollutants. The production process of medical masks in our company meets all the ISO EN13485: 2016 standard requirements, which define the production standards for medical devices.