Ansell BioClean MEA210-1 Sterile Looped Face Mask with Blue Clip - Class 10 / ISO 4 - 600 Masks/Case
Ansell BioClean™ MEA210-1 is a sterile, three-layer cleanroom face mask designed for critical contamination-controlled environments where facial coverage, low particle contribution, and controlled aseptic gowning are essential. Featuring non-latex polyurethane headloops and a blue plastic clip connector, the mask provides secure fastening behind the head while supporting compatibility with appropriate cleanroom hoods and gowning systems.
The flat-pleated white mask combines a soft polypropylene/polyethylene inner facing, meltblown polyester filtration layer, and hydrophobic spunbonded polyester outer facing. Ultrasonically sealed construction and an enclosed, adjustable plastic-coated steel noseband support consistent positioning, controlled handling, and wearer comfort.
BioClean MEA210-1 is suitable for Class 10 / ISO Class 4 cleanrooms and EU GMP Grade A/B controlled environments, subject to facility qualification. Each mask is gamma sterilized to a Sterility Assurance Level (SAL) of 10-6 and individually packaged with its blue clip connector. Manufacturer packaging contains 600 sterile masks per case.
Sterile Cleanroom Mask Advantage: BioClean MEA210-1 combines sterile presentation, Class 10 / ISO 4 cleanroom compatibility, documented particle, bacterial, and viral filtration performance, and a secure headloop-and-clip fastening system. Its individually sealed packaging and adjustable noseband support repeatable gowning procedures for critical pharmaceutical, biotechnology, laboratory, and sterile manufacturing operations.
Specifications:
- Manufacturer: Ansell
- Brand: BioClean™
- Manufacturer Part Number: MEA210-1
- Product Type: Sterile Looped Cleanroom Face Mask
- Mask Shape: Flat pleated
- Mask Color: White
- Cleanroom Classification: Class 10 / ISO Class 4
- EU GMP Applications: Grade A/B and other sterile cleanrooms, subject to facility qualification
- Sterility: Sterile
- Sterilization Method: Gamma irradiation
- Minimum Sterilization Dose: 25 kGy
- Sterility Assurance Level: 10-6
- Mask Construction: Three-layer nonwoven and filtration material system
- Inner Facing Layer: Nonwoven polypropylene/polyethylene, hygroscopic
- Filtration Layer: Meltblown polyester
- Outer Facing Layer: Nonwoven spunbonded polyester, hydrophobic
- Fastening Style: Headloop
- Headloop Material: Non-latex polyurethane
- Connector: Blue plastic clip for fastening behind the head
- Noseband: Plastic-coated steel, malleable
- Nominal Mask Width: 210 mm (8.27 inches)
- Nominal Mask Height: 95 mm (3.74 inches)
- Dimensional Tolerance: ±5 mm
- Particle Filtration Efficiency (PFE): 89.3% at 0.1 µm
- Bacterial Filtration Efficiency (BFE): 92.3% at 0.3 µm
- Viral Filtration Efficiency (VFE): 93.8% at 3.0 µm
- Differential Pressure: 3.8 mm H2O/cm²
- Referenced Standards: ASTM F2101, ISO 2859, ISO 9001:2015
- Manufacturing Quality-System Standard: ISO 9001
- Manufacturer Cleanroom Processing: NEBB-certified ISO Class 4 cleanroom environment
- Natural Rubber Latex: No natural rubber latex in the specified fastening construction
- Available Size: Universal
- Respirator Classification: Not a NIOSH-approved N95 respirator
- Reuse: Disposable, single-use product
- Individual Packaging: One sterile mask and blue clip per sealed polyethylene inner bag
- Outer Packaging: 50 individually sealed inner bags per sealed polyethylene outer bag
- Case Packaging: 12 outer bags per lined carton
- Case Quantity: 600 individual sterile masks
- Country of Origin: China
- Published Shelf Life: Five years from date of manufacture
- Storage Temperature: Below 40°C (104°F)
- Storage: Dry, cool conditions away from direct sunlight and fluorescent light
- Ordering Configuration: MEA210-1; universal size; case of 600 masks
About the Manufacturer:
Ansell develops protective gloves, apparel, facemasks, and contamination-control products for pharmaceutical manufacturing, biotechnology, medical devices, laboratory research, and other critical environments. Its BioClean™ product family includes sterile and non-sterile protective equipment designed to support facility gowning and contamination-control programs.
The BioClean MEA210-1 mask combines specialized nonwoven materials, ultrasonic construction, gamma sterilization, and protective packaging for controlled cleanroom applications. Ansell emphasizes the mask's filtration performance and blue clip connector, which provides an alternative to tie-on fastenings and conventional earloop configurations.
SOSCleanroom supports customers with Ansell cleanroom face-covering selection, manufacturer documentation, sterile material-transfer requirements, mask packaging information, and procurement assistance for critical environments.
BioClean MEA210-1 Features:
- Sterile three-layer cleanroom face mask
- Class 10 / ISO Class 4 cleanroom compatibility
- EU GMP Grade A/B application suitability
- Gamma sterilized to SAL 10-6
- Minimum 25 kGy sterilization dose
- Flat-pleated white mask design
- Soft, moisture-absorbing polypropylene/polyethylene inner facing
- Meltblown polyester filtration layer
- Hydrophobic spunbonded polyester outer facing
- Non-latex polyurethane headloops
- Blue plastic clip connector for rear-head fastening
- Fully enclosed malleable plastic-coated steel noseband
- Ultrasonically sealed construction
- Published PFE of 89.3% at 0.1 µm
- Published BFE of 92.3% at 0.3 µm
- Published VFE of 93.8% at 3.0 µm
- Manufacturer-reported differential pressure of 3.8 mm H2O/cm²
- Manufactured using cleanroom-compatible materials
- Individually packaged with clip connector
- Multilayer protective polyethylene packaging
- Five-year published shelf life
- 600 sterile masks per case
BioClean MEA210-1 Benefits:
- Sterile Presentation: Gamma sterilization and individual protective packaging support approved aseptic gowning procedures.
- Critical Cleanroom Compatibility: Designed for Class 10 / ISO 4 and applicable EU GMP Grade A/B environments.
- Documented Filtration Performance: Separate PFE, BFE, and VFE values support technical product selection.
- Secure Fastening: Non-latex polyurethane headloops and the blue connector allow the mask to be fastened behind the head.
- Adjustable Noseband: Plastic-coated steel can be shaped for comfortable and consistent placement.
- Breathability: Published differential-pressure performance supports assessment of airflow resistance and wearer comfort.
- Moisture Management: Hygroscopic inner facing helps manage moisture near the wearer.
- Outer Surface Design: Hydrophobic polyester facing provides a moisture-repellent exterior.
- Controlled Construction: Ultrasonic sealing helps limit loose material at construction joints.
- Hood Integration: Rear-head clip fastening can support compatible cleanroom hood and mask combinations.
- Standardized Gowning: Universal sizing and individually packaged units support repeatable personnel-entry procedures.
- Lot-Controlled Supply: Manufacturer packaging supports controlled receiving, stock rotation, and material issuance.
Common Applications:
- Aseptic pharmaceutical manufacturing
- ISO Class 4 cleanroom gowning
- EU GMP Grade A/B controlled environments
- Sterile filling and pharmaceutical packaging support
- Biotechnology manufacturing operations
- Medical device manufacturing and sterile assembly
- Controlled laboratory activities
- Critical material preparation and handling
- Cleanroom entry procedures requiring sterile masks
- Routine cleanroom gowning with compatible hoods
- Contamination-sensitive manufacturing and inspection
- Sterile operations where individually packaged facial coverings are required
- Personnel contamination-control programs using headloop fastening systems
Best-Practice Use:
- Follow the Gowning SOP: Use the mask in the approved sequence with the facility's hood, coverall, gloves, and other required apparel.
- Verify Product Identification: Confirm MEA210-1 and the manufacturer expiration date.
- Inspect Packaging: Check the sealed inner polyethylene bag before opening.
- Use Aseptic Opening: Present the mask without contacting its intended clean exterior or interior with unqualified surfaces.
- Handle the Headloops: Minimize touching the main mask material during donning.
- Position Correctly: Place the mask over the nose and mouth area according to the approved procedure.
- Fasten the Clip: Bring the headloops together and secure the blue connector behind the head.
- Adjust the Noseband: Shape the enclosed metal strip gently around the bridge of the nose.
- Verify Pleat Position: Expand the pleats sufficiently to provide the intended coverage.
- Confirm Hood Compatibility: Ensure the fastening arrangement remains secure with the selected hood.
- Avoid Repeated Adjustment: Limit unnecessary contact with the face mask once properly donned.
- Replace When Compromised: Change the mask if wet, damaged, displaced, or contaminated.
- Observe Area Changes: Follow required mask-change procedures when moving between work zones.
- Remove by the Fastenings: Avoid touching the front surface when doffing.
- Dispose After Use: Follow the facility's applicable waste and contamination-control procedures.
Sterile Donning and Blue Clip Fastening:
MEA210-1 uses non-latex polyurethane loops with a separate blue plastic clip fastener. The fastening arrangement helps secure the mask at the back of the head, making correct loop tension and connector positioning important elements of the gowning process.
- Prepare: Complete the required hand hygiene and preliminary gowning steps.
- Inspect: Confirm the sterile bag is intact and contains the mask and blue clip.
- Open: Open the sealed inner bag using the facility-approved aseptic technique.
- Present the Mask: Hold by the fastening components or approved handling areas without touching the primary filtration surface.
- Position: Arrange the mask over the nose and mouth, expanding the pleats for suitable coverage.
- Fasten: Bring the headloops behind the head and secure them using the supplied blue clip.
- Adjust: Shape the noseband to improve positioning and reduce unintended gaps.
- Integrate: Complete the hood and other gowning steps according to the approved sequence.
- Check: Turn the head and perform normal work movements to confirm the mask remains stable.
- Maintain: Avoid touching or repositioning the mask during critical operations unless required by the facility's corrective gowning procedure.
Headloop Fastening Guidance: The blue connector secures the polyurethane loops behind the head. Position the clip so the loops remain stable without excessive tension, and confirm that the mask and hood do not interfere with one another. Correct fastening supports gowning consistency but does not establish a respirator-grade facial seal.
Filtration Performance: PFE, BFE and VFE Explained:
Ansell publishes three separate filtration-efficiency results for MEA210-1. Each measurement addresses a different test challenge and should be interpreted using the manufacturer's stated particle size and testing conditions.
| Measurement |
Manufacturer Result |
What It Measures |
| Particle Filtration Efficiency (PFE) |
89.3% at 0.1 µm |
Filtration of particles under the specified particle-efficiency test conditions |
| Bacterial Filtration Efficiency (BFE) |
92.3% at 0.3 µm |
Manufacturer-reported efficiency against the specified bacterial filtration challenge |
| Viral Filtration Efficiency (VFE) |
93.8% at 3.0 µm |
Manufacturer-reported efficiency against the specified viral filtration challenge |
- Different Particle Sizes: Each value corresponds to a different reported test condition and should not be compared as if all three were measured using the same challenge.
- Laboratory Performance: Filtration results describe performance under defined testing conditions rather than actual total inward or outward leakage during wear.
- Mask Fit: The headloop fastening and noseband affect position, but the mask is not designed to form a certified tight-fitting respirator seal.
- Filtration Material: The meltblown polyester layer provides the primary filtration structure.
- Airflow Resistance: The manufacturer reports a differential pressure of 3.8 mm H2O/cm².
- Breathability Assessment: Differential pressure characterizes resistance to airflow under the specified method and is distinct from filtration efficiency.
- Contamination Control: Gowning discipline, correct placement, replacement frequency, and appropriate room controls remain essential.
Filtration Selection Guidance: MEA210-1 has documented PFE, BFE, and VFE results, but these are different measurements obtained under specified laboratory conditions. They do not establish N95 respirator certification, a guaranteed percentage of protection for the wearer, or equivalent performance against every airborne hazard.
Three-Layer Material Construction:
MEA210-1 incorporates three functional layers that contribute to wearer comfort, filtration, and surface handling. The overall mask construction should be evaluated for both cleanliness and compatibility with critical-area gowning procedures.
- Inner Facing: Hygroscopic nonwoven polypropylene/polyethylene intended to provide a comfortable surface against the wearer.
- Filtration Layer: Meltblown polyester supporting the published particle, bacterial, and viral filtration performance.
- Outer Facing: Hydrophobic nonwoven spunbonded polyester forming the exterior layer.
- Pleated Geometry: Allows the mask to expand for appropriate nose, mouth, and chin-area coverage.
- Ultrasonic Construction: Supports construction integrity and reduces reliance on loose stitched edge materials.
- Headloops: Non-latex polyurethane fastenings secure behind the head with the blue connector.
- Noseband: Malleable plastic-coated steel supports contouring around the nose.
- Single-Use Design: Material and mask construction are intended for disposal after the approved use period.
Sterile Packaging and Controlled Material Transfer:
Each MEA210-1 mask is individually sealed in polyethylene packaging together with its blue clip connector. The manufacturer uses additional protective bags and a lined carton to support controlled receiving, storage, and material transfer into sterile areas.
- Individual Inner Bag: One sterile mask and blue clip connector.
- Outer Bag: 50 individually sealed inner bags.
- Case: 12 sealed outer bags per lined carton.
- Total Case Quantity: 600 individually packaged sterile masks.
- Receiving Inspection: Confirm part number MEA210-1, lot identification, expiration date, and package integrity.
- Outer Carton Removal: Remove corrugated shipping materials at the approved receiving or staging area.
- Protective-Layer Transfer: Follow the facility's procedures for removing or sanitizing outer packaging layers before introducing materials into more critical areas.
- Individual Issue: Transfer a sealed inner bag for each operator according to the gowning procedure.
- Aseptic Opening: Open the sterile package without contacting the mask's intended clean surfaces.
- Clip Handling: Maintain control of the blue fastener during donning; do not place it on uncontrolled surfaces.
- Damaged Packaging: Reject masks from open, torn, wet, or otherwise compromised sterile bags.
- Material Traceability: Retain the required manufacturer lot and receiving records.
- After Opening: Use or discard the mask according to the approved sterile gowning procedure.
Sterile Transfer Guidance: Individual inner packaging supports one-mask-at-a-time issue while protective outer bags provide additional transfer layers. Maintain package integrity until the correct opening stage, and follow approved aseptic handling procedures for both the mask and supplied clip connector.
Face Mask, Face Veil and Respirator Selection:
Sterile cleanroom face masks, non-sterile face veils, and certified respirators serve different purposes. The appropriate product should be selected according to required sterility, cleanroom classification, fastening design, filtration properties, and any workplace respiratory hazards.
- MEA210-1 Sterile Looped Face Mask: Class 10 / ISO 4 sterile mask with polyurethane headloops, blue clip connector, and published PFE, BFE, and VFE performance.
- MTA210-1 Sterile Tie-On Face Mask: Alternative sterile cleanroom mask using a tie-on fastening arrangement.
- BFV05 Non-Sterile Face Veil: Headloop face veil designated by Ansell for Class 10,000 / ISO 7 applications, with published PFE of 85%.
- BDBS Sterile Pouch-Style Face Mask: Alternative sterile mask configuration for controlled gowning procedures requiring its specific mask design.
- Hood Compatibility: Verify fastening position, coverage, and interaction with the selected cleanroom hood.
- Sterility Requirements: Use sterile mask configurations when required by the facility's aseptic gowning procedures.
- Respiratory Hazards: A conventional cleanroom mask is not a replacement for approved respiratory protective equipment.
- NIOSH Respirators: Where the hazard assessment requires respiratory protection, select an appropriately certified respirator within the required respiratory protection program.
- Fit Testing: Occupational use of tight-fitting respirators requires applicable training, medical evaluation, and fit-testing procedures.
- Filtration Comparisons: Compare PFE, BFE, and VFE only with attention to the relevant testing methods and conditions.
Product Selection Guidance: Choose MEA210-1 when the process requires a sterile ISO Class 4 cleanroom mask with a headloop-and-clip fastening system. Consider tie-on or pouch-style sterile alternatives when the gowning configuration requires a different fastening or coverage design. For inhalation hazards requiring respiratory protection, use a properly selected and approved respirator instead of treating the cleanroom mask as an N95 equivalent.
Cleanroom Personnel Contamination Control:
- Facial Coverage: Cover the nose and mouth according to the approved gowning procedure.
- Operator-Generated Contamination: Speaking, breathing, facial contact, and excessive movement can contribute to contamination risk.
- Sterile Presentation: Keep each mask sealed until the appropriate point in the gowning sequence.
- Headloop Handling: Handle fastening components carefully to reduce contact with the main mask surface.
- Clip Security: Position the blue connector so headloop tension remains stable throughout the task.
- Noseband Position: Shape the enclosed metal strip gently and minimize subsequent adjustment.
- Hood and Mask Interface: Confirm that the hood does not displace the mask during movement.
- Gloved-Hand Contact: Follow the facility's glove-change or sanitization procedure if a worn mask must be adjusted.
- Wetness and Damage: Replace masks if they become wet, torn, or otherwise compromised.
- Routine Replacement: Follow the site-defined time- or event-based mask-change SOP.
- Personnel Training: Include correct sterile opening, clip fastening, fit checks, replacement, and doffing in gowning qualification.
Sterility, Shelf Life and Storage:
- Gamma Irradiation: Manufacturer-identified sterilization process.
- Minimum Dose: 25 kGy.
- SAL: 10-6 under the manufacturer's validated sterilization process.
- Shelf Life: Five years from date of manufacture.
- Lot-Specific Expiration: Follow the expiration date on the supplied packaging.
- Storage Environment: Cool and dry.
- Temperature: Below 40°C (104°F).
- Sunlight: Protect from direct sunlight.
- Fluorescent Light: Avoid prolonged fluorescent light exposure as directed by Ansell.
- Original Packaging: Keep unused masks protected inside their sealed manufacturer packaging.
- Physical Protection: Avoid crushing, excessive compression, wetting, and damage to the noseband or loops.
- Receiving Control: Inspect outer and inner packaging for evidence of damage or loss of seal integrity.
- Stock Rotation: Follow first-expiring-first-out inventory procedures where applicable.
- Single Use: Do not launder, reprocess, or reuse masks as sterile face coverings after wearing.
- Disposal: Follow applicable facility contamination-control and waste-management requirements.
Manufacturer Technical Documents:
Ansell BioClean MEA210-1 Manufacturer Product Information: Click Here
Ansell BioClean MEA210-1 U.S. Technical Data Sheet - Sterilization, Packaging and Filtration Performance (PDF): Click Here
BioClean MEA210-1 Product Data Sheet (SOSCleanroom PDF): Click Here
SOSCleanroom BioClean MEA210-1 Product Information: Click Here
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Notes: Need assistance selecting sterile cleanroom masks, comparing headloop and tie-on configurations, or interpreting PFE, BFE, and VFE data? Open the SOSCleanroom Technical Vault tab above for additional guidance on sterile mask selection, cleanroom gowning, material transfer, hood compatibility, contamination control, and filtration testing.
SOSCleanroom.com supports pharmaceutical, biotechnology, semiconductor, medical device, laboratory, and other critical environments with sterile face masks, cleanroom hoods, protective apparel, gloves, and specialized contamination-control supplies. Our team provides manufacturer documentation, product-selection assistance, packaging information, and procurement support.
Product description updated: October 23, 2026 (SOS Technical Staff)
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