ALFA disposable face mask - mouth and nose protection


Medical device according to the medical device directive
EC Directive 93/42 / EEC, Annex I in connection with 2007/47 / EC
Mouth and nose protection according to EN 14683: 2019 + AC: 2019 with CE marking
Packing unit in box: 50 pieces

Proven Quality


Test certificate
Eurotech Certification Frankfurt am Main / Germany (Conformity Certificate / Statement Of Compliance No: SC / 2020033)
It was checked whether it complies with the basic requirements and the relevant provisions of the EC Directive 93/42 / EEC Appendix 1 in the version of 2007/47 / EC for medical devices.

General information:


A mouth and nose protection is an aid in medicine to reduce the transmission of pathogens through secretion droplets to others (third-party protection).

It is usually a medical half face mask made of several layers of fleece, which is fixed with rubber bands on the back of the head or behind the ears. With an integrated flexible metal bracket in the middle of the upper edge, the half mask is pressed against the bridge of the nose to keep the field of view clear and to restrict the upward air outlet.

Medical mouth-nose protection is to be distinguished from simple paper or fabric masks (everyday mask) as well as particle-filtering FFP masks (respiratory mask), which (depending on the filter class) protect against the inhalation of micro-particles.

Mouth and nose protection products are classified into type I and type II in accordance with standard EN 14683: 2019, type IIR denotes a liquid-resistant protective mask.

Type I masks have a bacterial filter performance (BFE) of at least 95%, Type II and II R at least 98%. The breathing resistance must be less than 40 Pa / cm² for types I and II, and less than 60 Pa / cm² for type IIR. Masks of the liquid-resistant type IIR must withstand an injection pressure of at least 16 kPA.

Self-made makeshift masks made from commercially available materials for everyday private use are not considered medical devices or components of personal protective equipment. You may not replace professional masks in places where they are mandatory.

Application and reusability


For the use of medical mouth and nose protection in Germany, the Federal Institute for Drugs and Medical Devices has issued recommendations that the hands should be washed thoroughly before putting on the mask, in order not to contaminate the inside of the mask in particular.

The mask should completely cover the mouth and nose and fit as closely as possible around the edges “to minimize air penetration on the sides”. In addition, the outside of the mask should not be touched when wearing, since it is considered potentially pathogenic. After removing the mask, the hands should be washed again.

A dampened mask should be removed immediately and replaced if necessary. As a rule, mouth and nose protection must be disposed of as a disposable item after use.

Manufacturer


ALFA PROMOSYON TEKSTIL, Istanbul / Turkey
State-certified manufacturer and authorized exporter

Importer


COSMIC GmbH, Bad Kreuznach / Germany
Trading company since 1998 / import / export of specific products

Contact


COSMIC GMBH
Schwabenheimer Weg 111
55543 Bad Kreuznach
Germany

Phone: +49 (0) 671 796 5625
Fax.: +49 (0) 671 796 5621
E-Mail: alfa@cosmic-service.com
Web: www.cosmic-service.com

International contact

Mr. Philippe Plessers

PACT MUSEUM SOLUTIONS (Partner of Cosmic Group)

Phone:: +352 245 147 11
E-Mail: plessers@cosmic-service.com

    Contact


    COSMIC GMBH
    Schwabenheimer Weg 111
    55543 Bad Kreuznach
    Germany

    Phone: +49 (0) 671 796 5625
    Fax.: +49 (0) 671 796 5621

    E-Mail: alfa@cosmic-service.com
    Web: www.cosmic-service.com


    International contact
    Mr. Philippe Plessers

    PACT MUSEUM SOLUTIONS
    (Partner of Cosmic Group)

    Phone:: +352 245 147 11
    E-Mail: plessers@cosmic-service.com