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Ansell MEA210-1 BioClean Sterile Looped Face Mask Class 10 (ISO 4)

$702.90
(No reviews yet)
SKU:
MEA210-1
Availability:
7 - 10 Business Days
Shipping:
Calculated at Checkout
Quantity Option (Case):
600 Masks
Inner Packaging:
See Below
Sterile:
Yes

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.

Cleanroom gowning note: A mask is only effective when it is donned correctly and used as part of a complete gowning system (hood/hair cover, coverall or gown, boots, and gloves). Always follow your facility SOP and training requirements.

Specifications (Manufacturer Data Sheet Basis):
  • 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
About the Manufacturer:

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.

MEA210-1 Key Features:
  • 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
Benefits in Cleanroom Use:
  • 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.
Common Applications:
  • 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
Best-Practice Donning Tip (Looped Mask with Clip Connector):
  • 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.

Link to Ansell BioClean™ MEA210-1 Product Data Sheet (Manufacturer PDF):
Click Here

Related Ansell BioClean™ Mask Options From SOSCleanroom.com
  • 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)

SOSCleanroom capability: Since 1981, SOSCleanroom (Specialty Optical Systems, Inc.) has supported cleanrooms with critical supplies and long-term manufacturer partnerships, including Ansell. We have earned multiple distribution awards, including 11 Texas Instruments Supplier Excellence Awards.

If you need additional information please try our SOSCleanroom specific AI ChatBot which draws from our extensive cleanroom specific libraries.

Product page updated: Jan. 13, 2026 (SOS Technical Staff)

© 2026 SOS Supply. All rights reserved.

The Technical Vault
By SOSCleanroom
Last reviewed: April 27, 2026
Ansell BioClean™ MEA210-1 ISO 4 / Class 10 EU GMP Grade A/B Sterile (Gamma) SAL 10-6 Headloops + Clip 600/Case
MEA210-1 Sterile Looped Face Mask — contamination control is driven by behavior, not just the mask
Ansell BioClean MEA210-1 sterile looped face mask
MEA210-1 sterile looped face mask with clip connector
Practical reality in cleanrooms

In ISO 4/Class 10 environments, people are the dominant contamination source. Masks reduce droplets and some particulates, but real control comes from disciplined gowning, minimal handling, and consistent technique.

What it’s used for
  • ISO 4 / Class 10 and EU GMP Grade A/B environments
  • Sterile manufacturing and aseptic workflows
  • Programs requiring sterile masks with defined packaging
  • Facilities preferring headloop + clip configuration
Key advantages
  • Sterile gamma irradiation to SAL 10-6
  • Secure fit with headloops and clip connector
  • Ultrasonically sealed construction
  • Consistent packaging for controlled entry
Best-practice donning
  • Handle by loops and edges only
  • Secure clip once and avoid readjustment
  • Form noseband before gloving
  • Replace if wet, damaged, or touched excessively
SOSCleanroom note about SOP's

This content supports contamination-control decisions but does not replace your SOP. Always validate product use and handling within your internal quality system.

SOSCleanroom is the source for this Technical Vault entry.
Briefed and approved by the SOSCleanroom (SOS) staff.
If you have any questions please email us at Sales@SOSsupply.com
Last reviewed: April 27, 2026
© 2026 SOSCleanroom