Surgical FaceMasks

The mdd surgical FaceMask is developed to prevent any transmission of airborne infectious agent. The hig performance tested under the EN 14683:2019 confirm the efficacy of our facemask in professional areas

Classification

Medical device 
EN 14683:2019 Type IIR

Standards
The respiratory protection mask meets the requirements for protection class Type IIR surgical masks according to

EN 14683:2019.

Additional standards:

EN 149:2001+A1:2009
EN 1041:2008
EN ISO 10993-1:2009
EN ISO 10993-5:2009
EN ISO 10993-10:2010
ISO 15223-1:2016
EN ISO 14971:2012

Size

17×9.5 – Flat shape

Use

The mdd surgical Face Masks

Are projected to avoid droplet spreading secreted by human saliva and to prevent the transmission of pathogens.

The user of the Face Mask can be a healthcare professional or a patient who wants to protect themselves or others from transmission of pathogens.

Wear time

Dispose of after single use

Storage

In the original packaging, cool and dry, avoid the direct sunlight

Disposal

Safe thermal recovery or disposal in landfill. In the event of contamination, applicable laws and national regulations must be observed.

facemask 3 layer

Features

  • with nose-bridge
  • glass fibre free
  • with earloops
  • elastic loop round covered with cotton
Product code: FM-NV-B
Product description: Surgical Face Mask
The Face Mask meets the requirements of
DIN EN 14683:2019 for medical face masks / Classification Class Type IIR
respirator mask
delivery mask
facemask 3 layer
 

Requirements of the standard
EN 14683:2019
TYPE IIR
Bacterial filtration efficiency (BFE)
meets the following requirements
≥ 99,3 %
Breathability
(Differential pressure) Pa/cm2
≥ 19.9
Splash resistance

Pass

Microbial cleanliness (Bioburden)

≤ 30 CFU/g
CFU = colony-forming units

  

Material
Inner & external layers Polyester Fabric
Filter material

Non-woven polypropilene

Nose bridge

Iron wire covered with
polyethylene, detectable

Ear Loop

Nylon+Rubber band