tel.: +48 42 215 10 68
fax: +48 48 203 20 31
95-200 Pabianice,
ul.Piłsudskiego 23
E-mail adress:
oxyline@oxyline.eu
Filter respirator
Filter respirator cup shaped Oxyline

Filtering half mask X 210 FFP2 NR D

Description
PRODUCT CODE: X210FFP2NRD

The filtration half mask X 210 FFP2 NR D is a non-sterile single-use medical product, type II R. It complies with the requirements of EN 14683:2019 with a limited duration of use, up to a maximum of 8 hours. It has a bacterial filtration efficiency (BFE) of ≥ 98.0%. The respirator is approved for use in medical environments where there is a risk of splashing bodily fluids.

PURPOSE:
The filtration half mask X 210 FFP2 NR D
is intended for protection in places exposed to infectious and infectious materials where there is a risk of splashing of body fluids. It is used to cover the mouth, nose and chin. The product constitutes a barrier limiting the transmission of an infectious agent and protecting the respiratory tract. It prevents the spread of airborne microorganisms, reducing the risk of infection by medical personnel. Its use ensures sterile treatment conditions and protects the patient from viruses/bacteria e.g. during medical procedures.
The filtration half mask X 210 FFP2 NR D is also intended for use by medical personnel and patients in the event of exposure to blood and other potentially infectious body fluids. It is also designed to protect respiratory system against solid particles aerosols, water-based aerosols (dust, smoke) and aerosols with liquid dispersed phase (mist). for which the TLV is ≤0,05 mg/m3 as long as the dispersed phase concentration does not exceed 10 x TLV. (Threshold Limit Value)

EXAMPLES OF USE:
Half-masks can be used in environments with high concentrations of respirable dusts. They protect against harmful effects of dusts containing asbestos, beryllium, antimony, arsenic, cadmium, cobalt, nickel, radium, strychnine, radioactive particles, glass fibres, hard coal and brown coal, granite, marble, sandstone, dolomite etc. They can be used for work (cutting, grinding) of iron, steel and stone, wood in sawmills and carpenter's workshops; cleaning of castings and steel constructions, production and handling of lime, cement, fertilizers, raw materials for glass and ceramics industry, raw materials for rubber industry; production of flour and fodder. They protect against dusts causing pneumoconiosis - especially silicosis, dusts containing free silica of quartz (SiO2), chalcedony, cristobalite, opal, quartz glass, cement, hard coal, brown coal, talc, mineral wool, soil, grinding stones.
It is used also, in the chemical, glass, optical, electronic, foundry, construction and pharmaceutical industries.

DESCRIPTION:
The filtration half mask X 210 FFP2 NR D
is composed of the following elements:
• cup made of multilayer filtering material: polypropylene;
• a nose clip made of polypropylene tape reinforced with two steel wires;
• head bands;
• plastic fastenings of the head bands;
• nose seal made of polyurethane foam.

REQUIREMENTS:
Half mask X 210 FFP2 NR D
respirators comply with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical products, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance).
Half mask X 210 FFP2 NR D respirators have been designed and placed on the market in accordance with the Regulation of the European Parliament and Council (EU) 2016/425 of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC.
EN 14683:2019 + AC:2019 - Medical face masks – requirements and test methods
EN ISO 15223-1:2016 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
EN 1041:2008+A1:2013 - Information supplied by the manufacturer of medical devices
EN ISO 14971:2019 - Medical devices — Application of risk management to medical devices
EN 149:2001 + A1:2009 - Respiratory protective devices -- Filtering half masks for protection against particles - Requirements, testing, marking

Requirements with regard to the user's health harmlessness of the materials used, which is confirmed by a positive opinion of the Institute of Occupational Medicine in Lodz.
Downloads
Instruction - instrukcja półmasek Instruction Download
Declaration of Conformity - X210FFP2NRD Declaration of Conformity Download
Data sheet - X210FFP2NRD Data sheet Download
quanmedia