This face mask is not certified as a medical device or personal protective equipment. It is not intended for use by healthcare staff, for
occupational safety or as other protective device to protect against infection or other contaminants.
This face mask is intended for private use by the general public. In workplace, (other than health care workers and related) additional
protective measures should be implemented by the employer to protect workers. It is the employer’s responsibility to ensure the most
appropriate type of protection and compliance with applicable laws of safety and health to protect workers.
The wearer still needs to follow other risk reduction measures instructed by the competent authorities while wearing the mask as physical
distancing, hand hygiene, avoiding touching the face, nose, eyes, and mouth….
Face masks are not recommended for persons with any respiratory disease, children under 3 years old, people unconscious, disabled or for
any other reason in which a person cannot remove the mask without assistance.
Please read the product information and instructions before use.
Purpose of the mask:
The BUFF
®
Filter Mask plays a somewhat similar role as a physical barrier to reduce the spread of larger droplets
resulting from talking and/or coughing by the wearer when used correctly. Also wearing the BUFF
®
Filter Mask may help to limit touching
of the mouth and nose. The evidence about the benefits of barrier masks, also called community masks, non-medical masks, mouth&nose
masks, is however very limited and indirect.
Composition:
The BUFF
®
Filter Mask is composed by 2 fabrics: external fabric made of COOLNET
®
(95% Polyester and 5% Elastane) and
an internal fabric (inside pocket) made of (94% Polyester and 6% Elastane.
Filter FM70/310:
The BUFF
®
Filter Mask has been designed to be used together with the FILTER FM 70/310 to obtain the functionality and
performance of the product. The BUFF
®
Filter Mask incorporates an inside pocket to place the filter FM70/310.
The FM70/310 filter meets the performance requirements of the harmonised standard EN 14683: 2019 + AC, with regard to Bacterial
Filtration Efficiency (BFE%) and Differential Pressure (Pa/cm²)(Breathability), obtaining the Type Iª and II classification.
Performance requirements according to EN 14683:2019 + AC:
Bacterial Filtration Efficiency (BFE) determines the filtration efficiency as a barrier against bacterial penetration. The higher the percentage,
the greater the filtration efficiency.
Differential pressure is the difference between a certain pressure value and another reference value. The lower the differential pressure
value, the easier it is to breathe through.
The filter FM70/130 performs an air permeability of 280L/m²/s according to UNE-EN ISO9237 Textiles. Determination of permeability of
fabrics to air.
The combination of the BUFF
®
Filter Mask with the Filter FM70/310 meets the Differential Pressure (breathability) of the harmonised
standard EN 14683:2019+AC:2019 (< 60 Pa/cm²) Type IIR.
The filters are manufactured by Ahlstrom-Munksjö Italy Spa with a special design to fit the BUFF
®
Filter Mask and converted according to the
requests of EN ISO 13485. Medical Devices - Quality Management System by Ahlstrom-Munksjö Germany GmbH.
Composition of the Filter FM70/310:
The filter is 100% Polyester, it is binder-free, fiberglass-free, glue-free and latex-free. It is made of
three combined layers: Spunbond 20 gm² - Meltblown 30 gm² - Spunbond point bonded 20 gm2. The filter is water-repellent.
PRODUCT INFORMATION AND INSTRUCTIONS OF USE OF THE BUFF
®
FILTER MASK
ENG
Test
Type Iª
Type II
Type IIR
Bacterial Filtration Efficiency (BFE) %
95
98
98
16,0
Splash resistance Pressure (kPa)
Not required
Not required
Differential Pressure (Pa/cm²)
(breathability)
<40
<40
<60
4