How Did the Face Mask from the Prolen® Medical Line Receive Registration from SIDC?

Jan 13, 2022 | News

The face mask from our subsidiary Chemosvit Fibrochem is officially registered as a medical device. Fibrochem is so far the sole company in Slovakia to have a face mask registered as a medical device by the State Institute for Drug Control (SIDC). What makes this product unique?

A Slovak product with certificates and tests

The face mask (TYPE II) from the Prolen® Medical line is made of polypropylene fibres Prolen® Siltex and Prolen® Bodyfresh. These fibres are treated with a permanent antiviral and antimicrobial additive based on silver and zinc ions. That means that it does not penetrate the skin or wash out but retains its effectiveness throughout the life of the final product.

It is intended for reuse – its durability is at least 100 standard wash cycles. The mask, as well as other textiles from the Prolen® Medical line, is a 100% Slovak product. That means that the entire production process, from raw material to finalization, takes place in Slovakia.

The face masks are tested and certified under the EN 14683 + AC: 2019 standard and meet the health safety requirements according to the applicable legislation of the Slovak Republic and the European Union.

Effective protection even in a hospital environment

The fibres meet the health safety requirements according to the valid legislation of the Slovak Republic and the EU. They have antibacterial, antiviral and antifungal properties confirmed by laboratory tests.

The protection against Klebsiella pneumonia, Staphylococcus aureus and Escherichia Coli is 99.99% effective. The tested Aspergillus Niger fungus showed zero growth in the case of Prolen® Bodyfresh. The fibres also provide effective protection against coronavirus, as confirmed by tests by Virology Research Services Ltd.

The face mask is for healthcare professionals and patients in hospitals and other medical facilities, where the risk of microorganisms, body fluids, and other particles being transmitted is high. It is also suitable for ordinary use or in case of illness.

You can find more information about the face mask (TYPE II) in the product description in our online shop. You can read more about the Prolen® Medical line on this website.




Štúrova 101
059 21 Svit
Slovak Republic

tel: +421 52 715 1111-2
fax: +421 52 715 2740


The company is registered in the Commercial Register of the District Court Prešov, Section: Sa, File No. 136/P

Company registration number:
31 671 047
Tax identification number: 2020516861
VAT identification number: SK7020000273

GPS coordinates:
N49.056930°, E20.196140° (cars)
N49.058426°, E20.184921° (trucks)