BioClean Sterile MEA Looped Face Masks

• Manufactured from cleanroom compatible materials to reduce contamination into the controlled environment
• Features loops and clip connector to allow for quick and secure fastening at back of head
• High bacterial, viral, and particle efficiency filtration
• Fully enclosed malleable nose-band
• Ultrasonically sealed edges
• Manufactured in a facility holding ISO 9001:2015
• Processed in an NEBB certified ISO Class 4 cleanroom environment
• Sampling and inspection in accordance with ISO 2859-3:1994
• Tested against standard ASTM F2101 for Bacterial Filtration Efficiency (BFE)

Specifications:
• Inner Facing Layer: Non-woven polypropylene/polyethylene (hygroscopic)
• Filter layer: Meltblown polypropylene
• Outer Facing Layer: Non-woven polypropylene/polyethylene (hydrophobic)
• Fastenings: Non-latex polyurethane loops with blue plastic clip fastener
• Nose-Band: Plastic coated steel
• Color: White
• Style: Headloops
• Length (+/-5 mm): 210 mm
• Width: (+/-5 mm): 95 mm
• Sterilization: Gamma irradiation
• Minimum Dose: 25 kGy
• Sterility Assurance Level: 10-6
• Compatibility: ISO Class 4 and EU GMP Grade A
• Particle filtration efficiency (PFE) @ 0.5 micron: >97%
• Bacterial filtration efficiency (BFE) @ 3.0 micron: >96.5%
• Viral filtration efficiency (VFE): 97.9%
• Differential pressure (P), mm H20/cm2: 3.2
• Packaging: One piece (with blue clip) per sealed inner PE bag; 50 inner bags per sealed outer PE bag; 12 outer bags per lined carton (600 pieces)

Image(s) are representative of the product group and not necessarily the individual product.
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• Manufactured from cleanroom compatible materials to reduce contamination into the controlled environment
• Features loops and clip connector to allow for quick and secure fastening at back of head
• High bacterial, viral, and particle efficiency filtration
• Fully enclosed malleable nose-band
• Ultrasonically sealed edges
• Manufactured in a facility holding ISO 9001:2015
• Processed in an NEBB certified ISO Class 4 cleanroom environment
• Sampling and inspection in accordance with ISO 2859-3:1994
• Tested against standard ASTM F2101 for Bacterial Filtration Efficiency (BFE)

Specifications:
• Inner Facing Layer: Non-woven polypropylene/polyethylene (hygroscopic)
• Filter layer: Meltblown polypropylene
• Outer Facing Layer: Non-woven polypropylene/polyethylene (hydrophobic)
• Fastenings: Non-latex polyurethane loops with blue plastic clip fastener
• Nose-Band: Plastic coated steel
• Color: White
• Style: Headloops
• Length (+/-5 mm): 210 mm
• Width: (+/-5 mm): 95 mm
• Sterilization: Gamma irradiation
• Minimum Dose: 25 kGy
• Sterility Assurance Level: 10-6
• Compatibility: ISO Class 4 and EU GMP Grade A
• Particle filtration efficiency (PFE) @ 0.5 micron: >97%
• Bacterial filtration efficiency (BFE) @ 3.0 micron: >96.5%
• Viral filtration efficiency (VFE): 97.9%
• Differential pressure (P), mm H20/cm2: 3.2
• Packaging: One piece (with blue clip) per sealed inner PE bag; 50 inner bags per sealed outer PE bag; 12 outer bags per lined carton (600 pieces)

Image(s) are representative of the product group and not necessarily the individual product.

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2023