FFP2 face mask

Dutch PPE Solutions will help meet the urgent need to diversify the global, large-scale production and supply chains of personal protective equipment and reduce dependency on a limited number of manufacturers. Thanks to the realisation of the first permanent production facility for critical filter material and FFP2 face masks in the Netherlands, Dutch PPE Solutions will provide more resilience should the demand for face masks and the materials required for them increase in the future.

FFP2

FFP2 masks have an efficiency rate of at least 94%. Side leakage should not exceed 8%. FFP2 masks are suitable for industrial and medical use and offer protection against airborne biological agents from risk group 2, e.g. pollen and bacteria such as TB.

Characteristics

The face masks from Dutch PPE Solutions have been extensively tested and meet all the requirements set to FFP2 face masks. In addition, during the development phase, various factors have been taken into account that make wearing a face mask more comfortable. For example, the FFP2 mask from Dutch PPE Solutions is completely latex-free, so that people with a latex allergy too can safely wear the mask. In addition, the mask is designed in such a way that less condensation occurs when worn in combination with glasses. The FFP2 mask from Dutch PPE Solutions further offers increased comfort thanks to its low breathing resistance. This is certainly an advantage over other FFP2 masks when performing strenuous activities.

Want to receive more information about the FFP2 face masks from Dutch PPE Solutions? Please contact us.

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Technical information

Regulations

MDD 93/42/EC, 2007/47/EC	Medical Devices Directive
EN 149:2001 + A1:2009	Respiratory protective devices
ISO 15223-1:2016	Medical devices – Symbols to be used with medical devices, labels, labelling and information to be supplied. Part 1: General requirements.
EN 1041+A1:2013	Information supplied by the manufacturer of medical devices.
EN 14971:2019	Medical Devices – Application of Risk Management
ISO 10993-10:2013	Biological evaluation of medical devices. Part 10: Test for irritation and skin sensitization.
ISO 16142-1:2016	Medical devices-Recognized essential principles of safety and performance of medical devices. Part 1: General essential principles and additional specific principles for all non-IVD medical devices guidance on the selection of standards.
EN 62366-1:2015	Medical devices. Part 1: Application of usability engineering to medical devices
GMDN	35177
CE	CE 2797
EU 2016/425	Personal Equipment Regulation
EU MDR 2017/745	Medical Devices Regulations

Material

First layer	Spunbond PP nonwoven fleece, orange
Second layer	Meltblown PP nonwoven, white
Third layer	Meltblown PP nonwoven, white
Fourth layer	Colback nonwoven
Fifth layer	Spunbond PP hydrophobic, white
Head loop	Nylon/Spandex
Nose clamp	Aluminum (between the nonwoven layers)

Packaging

Package	Material	Size (L x W x H) mm
Single Pack	Not available	Not available
Dispenser Pack (25 pieces)	Carton, FSC	140x130x180
Transport Carton (24 dispensers)	Cart board	560x395x375