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Foldable FFP2 mask | Non-Valved |

Medical FFP2 mask thanks to EN149 ánd EN14683 conformity!
Foldable FFP2 mask | Non-Valved |

Product description

Normally, FFP2-masks only meet the EN149-norm, since this is the mandatory European norm for this mask. Initially, the FFP2 mask was not primarily designed for medical use, and is normally mostly used as dust mask. However, the COVID-19 pandemic resulted in an enormous increase in the medical use of FFP2 masks, as they do offer supreme protection of both the user (when breathing in) and the patient (when breathing out). Therefore, to further and officially prove suitability for medical use in protection against COVID-19, in addition to the mandatory EN149 norm our foldable FFP2 mask has been also independently and additionally tested for EN14683 conformity. This norm is normally only applicable for surgical masks, and covers amongst others the Bacterial Filtration Efficiency (BFE) and splash resistance. Since this product meets both mentioned EN norms, it is proven suitable for medical use, even when an increased risk exists for infectious diseases transferred through bodily fluids.

 

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Product information

Color White
Size Universal
Product code HM-174530
Unit of Measure BOX/20

Specifications

CE-markering Non sterile Single use Don't use when packaging appears damaged Storage temperature Avoid direct sunlight Store in a dry environment Latex free PHT-free
Classification
  • Medical Device - Class I (MDR EU2017/745 Annex VIII)
  • Personal Protective Equipment (PPE) cat. III
Certification
  • Manufactured according to ISO 13485 standards
  • EC Declaration of Conformity
  • PPE cat. III certified (EU Type Examination certificate (Module B) and Production Conformity to Type certificate (Module D))
Dimensions

Length 19 cm (± 1 cm) x height 9.5 cm (± 0.5 cm)

Material Polypropylene (PP) non-woven & Polypropylene (PP) filter fibre
Outer layer PP non-woven, 50gsm (±3gsm)
Middle layer PP filter fibre, 40 gsm (±3gsm)
Inner layer PP non-woven, 32gsm (±3gsm)
Breathing resistance <60Pa/cm2 (Differential pressure (Pa/cm2)) (EN14683:2019 Annex C)
Bacterial Filtration Efficiency (BFE) >98% (EN14683:2019 Annex B)
Microbial cleanliness <30cfu/g (EN ISO11737-1:2018)
Ear loops Synthetic rubber with Lycra, latex free, total length: 60 cm (±5 cm), exposed length: 56 cm (±5 cm)
Nose clamp Adjustable nose clamp for optimal protection, with soft sponge foam on inside for optimal comfort
Splash resistance Yes, >16Kpa (as per ISO 22609:2004)
Norms
  • EN 149:2001 + A1:2009 
  • EN 14683:2019 + AC:2019
Applications

Since this product meets both the EN149- and the EN14683-norm, it can be used both in medical and non-medical settings. Non-medical use of FFP2 masks often happens in dusty environments, which is why FFP2- and FFP3 masks are often referred to as 'dusk masks'. However, with its proven EN14683 conformity, this mask proves to be a versatile product with clear proof for medical use. 

Packaging information Packed in dispensers of 20 masks. 20 dispensers per carton.
Additional specifications
  • Non-sterile
  • Single-use only 
Ordering information
Productcode
Unit
HM-174530 BOX/20