Sterile Pouch Style Facemask - BDBS

Description:

Breathability & Comfort
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.

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Packaging: 1 Mask individually sealed in an inner bag, 20 bags/ outer bag, 10 outer bags/carton.  200 pieces total

Additional Information:

Color: White
Construction:    Seams: Ultrasonically bonded. Outer facing: Spunbonded polyester (non-woven). Filter layer: Meltblown polyester. Inner facing: Spunbonded polyester (non-woven). Headloops: Tubular knitted polyurethane Spandex yarn. Spacer: Non-latex band. Nose bridge: Fully enclosed coated malleable aluminium.
Style/Type: Headloop
Sterilization Method: Gamma irradiation.
Physical Properties:  Particle filtration efficiency (PFE): 98.2% Bacteria filtration efficiency (BFE): 97.9% Differential pressure drop in mm H2O/cm2 3.57
Packing: Bagged
Particulates: Processed in a cleanroom environment to ensure compatibility with ISO Class 4 operating conditions.
Sterile: Sterile
Quality Systems: Manufactured in a facility holding the following registrations: ISO 9001:2008 and ISO 13485:2003.
Sampling & Inspection: In accordance with ISO 2859 standard procedures.
Storage Instructions: Store in a dry, cool place (<40°C) away from direct sunlight and fluorescent light.
Shelf Life: Five (5) years from date of manufacture.
Bar Codes: This is shown on the carton to allow automatic data entry into Stock Control Systems.
Lot Number: This is shown on the sealed outer bag and the carton to provide product traceability.
Compatibility: ISO Class 4 & EU GMP Grade A.