25Oct

FDA Approved FFP2 Safety Mask Added To Product Portfolio For US Market

As the Covid-19 pandemic is heavily hitting the whole world with high infection rates and a horrifying death toll, we decided to expand our product portfolio in the filtration sector and are now able to provide a high quality FDA approved safety mask to healthcare providers and private companies based in the US.

We are offering a FDA approved and certified FFP2 PPE mask based on melt-blown filter material (>99% filtration efficiency) awarded with Class “A” certification according to the EN 14683:2019 Standard.

  • Production capacity: 12 million FFP2 masks per year
  • Annual filtration media production capacity: approx. 3 million m2 (~32million sqf)

The filter material was developed in Italy, is produced in a plant in northern Italy, tested and certified by the University Politecnico of Milan, and assembled in an Italian owned plant in China near Shanghai.

Here the link to the relevant FDA website page:

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas?from=singlemessage&isappinstalled=0#appendixa

FFP2 MASK  
FILTRATION EFFICIENCY ≥98% @0,6µm@95l/min
INHALATION RESITANCE ≤240Pa @ 95 l/min
EXHALATION RESISTANCE ≤300Pa @ 160 l/min

Four-layers face mask with ear holder and adjustable nose clip. Ultrasonically welded.

Produced in accordance to EN 149:2001+ A1:2009 standard.

The production line is in UFI Filters Shanghai.

Masks are supplied in single plastic bags to ensure cleanliness and avoid contamination - 20 pieces per box.

Must be stored in well-ventilated, dark and dry environment, away from fire and pollution.

Recommended storage conditions:
Temperature -4 F°/+86 F° and rel. humidity less than 85%.
Shelf Life: 3 years.

 

For quote and further information please contact our Offices in Charlotte NC:

BORSERINI Industrial Trading llc  
101 N. Tryon St. Suite 112
Charlotte, NC 28246 Tel: +1 704 547 3285 / +1 704 998 5670 Fax: +1 704 998 5301
CAGE# AJ061
20 Pcs Packaging