Constructed with a patented spacer to maintain clear breathing space, the BioClean DB Sterile Pouch-style Facemask ensures exceptional breathability, comfort and protection for the wearer. The outer and inner facings of these face masks are made from non-woven spunbonded polyester between which is a particularly efficient particle and bacteria filtration layer of meltblown polyester. The three layers are ultrasonically sealed giving high-strength seams. The mask’s fully enclosed nose-band is made from coated malleable aluminium and the headloops from tubular knitted polyurethane Spandex yarn. Sterilization is by gamma irradiation. With a shelf-life of five years, the “one-size-fits-all” white mask is manufactured in a facility holding ISO 9001:2008 and ISO 13485:2003 certifications and processed to ensure ISO Class 4 and EU GMP Grade A compatibility. One mask is individually sealed in an inner bag, 20 of which are then sealed in an outer bag. A carton contains 10 outer bags, making 200 pieces in total.