Ansell MEA210-1 BioClean™ Sterile Looped Face Mask — Class 10 (ISO 4) — 600/Case

The BioClean™ MEA210-1 is a sterile, single-use cleanroom face mask designed to reduce operator-generated contamination in ISO-classified environments. It features headloops with a blue clip connector for quick, secure fastening behind the head, a fully enclosed malleable noseband, and ultrasonically sealed edges. Each mask is packaged one per sealed inner PE bag to support controlled handling and transfer practices.

• Manufacturer / Brand: Ansell — BioClean™
• Re-order code / SKU: MEA210-1
• Cleanroom class compatibility (manufacturer): Class 10 / ISO Class 4; EU GMP Grade A/B and other sterile cleanrooms
• Mask style: Flat pleated face mask with headloops (looped) and blue clip connector
• Color: White
• Overall dimensions (± 5 mm): 210 mm (width) x 95 mm (height)
• Noseband: Fully enclosed plastic-coated steel noseband
• Edges: Ultrasonically sealed
• Fastenings: Non-latex polyurethane loops with blue plastic clip fastener
• Packaging (case): 600 masks/case (1/inner bag; 50 inner bags/outer bag; 12 outer bags/lined carton)
• Sterilization method: Gamma irradiation (minimum dose 25 kGy)
• Sterility assurance level: SAL 10^-6
• Shelf life: Five (5) years from date of manufacture
• Storage: Store in a dry, cool place (< 40°C) away from direct sunlight and fluorescent light
• Performance (manufacturer): PFE 89.3% @ 0.1 micron; BFE 92.3% @ 0.3 micron; VFE 93.8% @ 3.0 micron; Differential pressure 3.8 mm H₂O/cm²
• Standards listed by manufacturer: ASTM F2101; ISO 2859; ISO 9001:2015

Ansell’s BioClean™ portfolio is engineered for contamination-controlled environments where controlling human-generated particulate and microbial risk is essential. For MEA210-1, Ansell emphasizes cleanroom-compatible materials, sterile processing, and a headloop + clip-connector format intended to support consistent fit and repeatable donning behavior in critical areas.

• Sterile by design: gamma irradiated to SAL 10^-6
• Clip connector: quick, secure fastening at the back of the head (blue clip)
• Ultrasonically sealed edges: reduces edge-shed risk versus unsealed constructions
• Fully enclosed malleable noseband: supports improved fit and seal discipline
• Non-latex headloops: polyurethane loops
• Controlled packaging: one mask per sealed inner PE bag; 600 per case

• Supports contamination control: helps reduce droplets/particulates from speaking and breathing as part of a complete gowning system.
• Improves SOP consistency: sterile, individually packaged masks reduce “unknown handling history” variability.
• Stable fit for longer wear: headloops plus clip connector can be more secure than earloop-only designs during movement.
• Audit-friendly selection: manufacturer publishes sterility method/SAL, packaging configuration, and test/standard references.

• ISO Class 4 / Class 10 cleanrooms and other contamination-sensitive controlled environments
• EU GMP Grade A/B sterile-area workflows (facility and CCS/SOP dependent)
• Life sciences, aseptic processing support zones, medical device, and microelectronics (process dependent)
• General contamination-control programs needing consistent mask packaging and donning behavior

• Handle by the loops/edges: avoid touching the mask face (outside surface).
• Place and clip intentionally: position mask, pull loops back, then secure the clip at the back of the head for stable tension.
• Set the noseband once: form the enclosed noseband for seal, then avoid repeated adjustments after gloving.
• Replace when compromised: if wet, torn, or repeatedly touched, replace per SOP.

• MTA210-1: BioClean™ sterile tie-on face mask (Class 10 / ISO 4)
• BDBS: BioClean™ sterile DB pouch-style face mask (Class 10 / ISO 4)
• BDBS-G: DB pouch-style face mask with neck guard (Class 10 / ISO 4)