Class 1 Medical device: Disposable 3 ply Medical face mask with ear loop.
This is for use in the medical industry and has been manufactured under the guidance outlined in the medical devices directive 93/42/EEC (MDD)
This is not PPE and is not certified under the PPE Regulation (EU) 2016/42.
The item is a Type I mask which means it is suitable to reduce the risk of spread of infections.
In terms of performance the type I mask meets the below:
bacteria filtering effectiveness > 95%.
differential pressure < 40
splash resistance (not tested) Not applicable to type I
Microbial cleanliness < 30
The product is manufactured :
- following the requirements outlined in EN14683 - our manufacturer has provided evidence to show the product meets EN14683
- under an approved quality management system which meets ISO 13485, this has been performed and issued by SGS.
The product is single use only & is non sterile.
The AIR+ Active Ventilator snaps onto the Smart Mask, transforming disposable masks into advanced masks with performance and comfort. It expels accumulated heat, humidity and eliminates CO2 build-up within a mask for active circulation and cooling with every breath.
Enhanced protection and comfort for use with AIR+ Smart Mask with valve (not supplied PP5593). Reduces physiological symptoms such as headaches, dizziness and reduced alertness.
4 hrs running time per charge. Re-charged in an hour via micro-USB
Can be partially charged during breaks – just like your mobile
Large surface area ensures very low breathing
resistance
New large exhalation valve which reduces heat
build-up and improves wearer comfort
Colour coded alphamesh shell for ease of
identifi cation
Adjustable headstrap allows for a secure and
comfortable fi t
Metal-free - suitable for food industry
applications
Preformed nosebridge eliminates the need
for regular adjustment
Compatible with a wide range of safety
eyewear
Soft fl exible mesh maintains it’s shape
and will not collapse during use
Conforms to EN 149: 2001 + A1: 2009
Our FFP3 respirator offers even greater levels of respiratory protection against airborne particulates including biological substances, enzymes and fine dusts.
Elasticated strap
Adjustable nose bridge and soft nose seal for improved fit
Valved to avoid heat build-up for greater comfort
(Price is for one mask)