Ansell BioClean Advance BASL Sterile Latex Cleanroom Gloves - Class 10 / ISO 4 - 200 Pairs/Case
Ansell BioClean™ Advance BASL sterile latex cleanroom gloves are designed for critical contamination-controlled environments where sterile hand protection, tactile sensitivity, and reliable grip are essential. Manufactured from natural rubber latex, these powder-free gloves feature textured fingers, a chlorinated interior, and a beaded cuff to support controlled donning and precise handling during pharmaceutical, biotechnology, laboratory, and other cleanroom operations.
BioClean Advance BASL gloves are compatible with Class 10 / ISO Class 4 cleanroom applications and are supplied sterile following gamma irradiation, with a sterility assurance level (SAL) of 10-6. Their hand-specific construction and approximately 295 mm length support dexterity and gown-to-glove overlap. EasyTear® polyethylene packaging helps facilitate controlled opening and sterile glove presentation.
Each pair is individually packaged in a protective polyethylene wallet and sealed EasyTear® pouch. The gloves are supplied in cases of 200 pairs and are available in sizes 6 through 9, including half sizes.
Sterile Cleanroom Protection Advantage: BioClean Advance BASL combines sterile presentation, Class 10 / ISO 4 cleanroom compatibility, textured fingertip grip, and natural latex flexibility. Its pair-packed EasyTear® presentation and suitability as an outer glove in double-gloving procedures support controlled gowning and glove-change practices in critical cleanroom environments.
Specifications:
- Manufacturer: Ansell
- Brand: BioClean™
- Product Family: BioClean Advance
- Model: BASL
- Product Type: Sterile Disposable Latex Cleanroom Gloves
- Glove Material: Natural rubber latex
- Material Color: Natural
- Powder Content: Powder-free
- Cleanroom Classification: Class 10 / ISO Class 4
- Additional Cleanroom Applications: EU GMP Grade A/B and other sterile cleanroom environments, subject to facility qualification
- Sterility: Sterile
- Sterilization Method: Gamma irradiation
- Minimum Sterilization Dose: 25 kGy
- Sterility Assurance Level: 10-6
- Freedom from Holes: AQL 1.5, Inspection Level I, Performance Level 2
- Glove Shape: Hand-specific
- External Surface: Textured fingers
- Internal Surface: Chlorinated
- Cuff Style: Beaded
- Typical Glove Length: 295 mm (11.6")
- Target Palm Thickness: 0.20 mm (7.87 mil), according to the U.S. PDS
- Target Finger Thickness: 0.24 mm (9.44 mil)
- Target Cuff Thickness: 0.18 mm (7.09 mil)
- Typical Particle Count: Less than 2,000 particles/cm² at ≥0.5 µm, according to published manufacturer testing
- Total Extractable Protein: 50 µg/g or less
- Antistatic: No
- Tested for Use with Chemotherapy Drugs: No
- Double-Gloving Recommendation: Yes, as an outer glove
- Available Sizes: 6, 6.5, 7, 7.5, 8, 8.5, 9
- Packaging: Individually pair-packed, EasyTear® polyethylene presentation
- Case Quantity: 200 pairs
- Country of Origin: Malaysia
- Shelf Life: 5 years from date of manufacture, subject to labeled expiration and storage requirements
- Storage: Cool, dry conditions away from direct sunlight, ozone, and ignition sources
- Ordering Configuration: Case of 200 pairs; select the required glove size
About the Manufacturer:
Ansell manufactures protective gloves and apparel for life sciences, pharmaceutical manufacturing, biotechnology, healthcare, laboratory research, electronics, and controlled manufacturing environments. Its BioClean™ portfolio includes sterile and non-sterile gloves, garments, and accessories developed for contamination-sensitive applications.
The BioClean Advance BASL series combines natural rubber latex construction with controlled cleanroom processing, gamma sterilization, and protective polyethylene packaging. These characteristics help facilities manage material cleanliness, sterility, operator dexterity, and glove handling during critical operations.
SOSCleanroom supports customers with Ansell product selection, manufacturer documentation, sterile glove sizing, packaging configurations, and procurement assistance for critical environments.
BioClean Advance BASL Features:
- Sterile natural rubber latex cleanroom glove construction
- Class 10 / ISO Class 4 cleanroom compatibility
- Gamma sterilized to SAL 10-6
- AQL 1.5 freedom-from-holes performance
- Powder-free construction
- Textured fingers for controlled grip
- Chlorinated interior for improved donning characteristics
- Hand-specific design for comfortable fit and dexterity
- Beaded cuff for donning stability
- Approximately 295 mm glove length
- Recommended by Ansell for double-gloving as an outer glove
- EasyTear® packaging designed for controlled opening
- Individually sterile pair-packed presentation
- Published particle and extractable-protein data
- Seven available glove sizes
- 200 pairs per case
BioClean Advance BASL Benefits:
- Sterile Presentation: Gamma irradiation and individual pair packaging support approved sterile gowning procedures.
- Cleanroom Compatibility: Designed for demanding Class 10 / ISO 4 contamination-control applications.
- Natural Latex Flexibility: Elastic latex construction provides a close fit and tactile feedback during precision handling.
- Textured Fingertip Grip: Supports controlled manipulation of tools, containers, equipment, and components.
- Comfortable Donning: Chlorinated internal surfaces support glove application without added powder.
- Stable Cuff Design: Beaded cuffs help maintain a secure gown-to-glove interface.
- Double-Gloving Compatibility: Suitable for use as an outer glove in facility-approved layered glove procedures.
- Protective Packaging: EasyTear® pouches help support controlled transfer, opening, and aseptic handling.
- Documented Barrier Quality: AQL 1.5 provides a standardized freedom-from-holes quality classification.
- Traceable Supply: Manufacturer labeling and documented packaging support controlled receiving and material management.
- Case Procurement: Standard 200-pair case packaging supports recurring cleanroom glove requirements.
Common Applications:
- Aseptic pharmaceutical manufacturing
- Sterile processing and controlled gowning operations
- ISO Class 4 contamination-controlled environments
- Biotechnology manufacturing and laboratory operations
- Sterile material transfer and handling
- Medical device manufacturing and sterile assembly
- Precision handling of sensitive components
- Controlled laboratory sampling and inspection
- Cleanroom equipment preparation and cleaning
- Outer-glove applications in approved double-gloving procedures
- Critical manufacturing operations requiring sterile hand protection
- Pharmaceutical compounding activities where latex gloves are permitted and provide the required protection
Best-Practice Use:
- Confirm Material Suitability: Verify that natural rubber latex is permitted under the facility's allergy-management and PPE policies.
- Select the Correct Size: Use the manufacturer sizing options to obtain a secure fit without excessive tension or loose fingertips.
- Inspect Packaging: Check protective pouches for tears, damage, moisture intrusion, or compromised seals before opening.
- Verify Expiration: Confirm the product is within its labeled shelf life.
- Follow Transfer Procedures: Introduce sterile glove packaging into controlled areas according to the facility's approved material-transfer process.
- Open Carefully: Use the EasyTear® pouch as intended and avoid uncontrolled tearing or unnecessary package manipulation.
- Use Aseptic Donning: Avoid touching the external glove surfaces with unqualified hands or equipment.
- Maintain Gown Overlap: Ensure an appropriate interface between glove cuffs and cleanroom garment sleeves.
- Double-Glove When Required: Follow the facility's defined inner-glove and outer-glove procedures.
- Change Compromised Gloves: Replace gloves after tears, punctures, suspected contamination, or loss of sterility.
- Control Sanitization: Use only approved glove sanitization procedures supported by material compatibility and facility requirements.
- Prevent Cross-Contamination: Replace gloves between tasks or zones when required by approved procedures.
- Dispose Properly: Discard used gloves according to applicable contamination-control and waste-management requirements.
Natural Rubber Latex Allergy Considerations:
BioClean Advance BASL is manufactured from natural rubber latex. Although natural latex provides excellent flexibility and tactile sensitivity, it contains proteins that can cause allergic reactions in susceptible individuals. Powder-free construction and controlled extractable protein levels do not make natural rubber latex allergy-free.
- Latex Allergy: Natural rubber latex may cause Type I immediate hypersensitivity reactions, including potentially serious allergic responses.
- Exposure Assessment: Confirm whether workers, patients, or other persons may have known or suspected latex sensitivity.
- Facility Latex Policy: Follow workplace requirements for latex product identification, restrictions, and approved alternatives.
- Protein Content: The manufacturer publishes a total extractable protein level of 50 µg/g or less; this does not eliminate sensitization or allergic reaction risk.
- Powder-Free Construction: Helps avoid glove powder as a potential contamination source but does not remove natural latex proteins.
- Material Alternatives: Select qualified nitrile, neoprene, or other latex-free gloves where natural rubber latex is unsuitable.
- Operator Training: Ensure personnel understand applicable glove-allergy precautions and reporting procedures.
Latex Material Selection: BASL contains natural rubber latex and should not be selected for personnel or applications requiring latex-free gloves. Facilities should evaluate latex allergy risks and select an appropriate sterile synthetic alternative whenever natural rubber latex is prohibited or unsuitable.
AQL, Cleanroom Performance and Sterility Explained:
- AQL 1.5: Represents a manufacturer quality classification for freedom from holes under the applicable standardized inspection method. It does not mean every glove is guaranteed free from defects.
- ISO Class 4: Indicates the glove's intended cleanroom compatibility. A glove's designation does not independently certify the cleanliness classification of the room in which it is used.
- Gamma Sterilization: Gloves are processed by gamma irradiation according to the manufacturer's validated sterilization program.
- SAL 10-6: Describes the sterility assurance level associated with the validated sterilization process, not a guarantee against contamination after opening.
- Particle Performance: Published particle-count data support product selection and qualification, but contamination introduced during handling remains process dependent.
- Glove Integrity: Tears, punctures, improper donning, and contact with uncontrolled surfaces can compromise protective performance.
- Cleanroom Qualification: Material selection should be supported by the facility's contamination-control strategy and approved procedures.
Cleanroom Performance Guidance: Sterility, freedom from holes, and particle cleanliness describe different performance characteristics. Selecting a sterile ISO 4 glove does not eliminate the need for appropriate gowning technique, packaging controls, glove inspection, change-out procedures, and ongoing environmental monitoring.
Double-Gloving and Sterile Gowning Guidance:
Ansell recommends BASL for use as an outer glove in double-gloving procedures. Layered glove systems can support sterile gowning and controlled glove replacement, but the configuration should be determined by the facility's documented contamination-control procedures and required protection.
- Outer-Glove Selection: BASL can be selected as the outer layer when the material, fit, and required protection are suitable.
- Inner-Glove Selection: Choose compatible inner gloves according to the facility's gowning procedure, material requirements, and allergy policy.
- Sizing: Evaluate combined glove fit to avoid excessive tightness, loss of dexterity, or restricted hand movement.
- Gown Interface: Maintain appropriate glove and sleeve overlap throughout working movements.
- Controlled Donning: Follow aseptic technique when putting on or replacing outer gloves.
- Change-Out Frequency: Establish replacement criteria based on process contamination risk, task changes, and glove integrity.
- Surface Contact: Replace or appropriately manage gloves after contact with nonqualified surfaces.
- Disinfection Procedures: Use only cleaning or sanitizing methods compatible with the glove material and approved by the facility.
- Damage Inspection: Remove torn, punctured, deteriorated, or otherwise compromised gloves immediately.
Chemical Protection and Chemotherapy Selection:
BioClean Advance BASL is designed for sterile cleanroom handling and has published manufacturer chemical-permeation information. Chemical protection must be assessed separately from sterility, AQL, and cleanroom classification. Ansell identifies BASL as not tested for use with chemotherapy drugs.
- Chemotherapy Testing: BASL is not designated by Ansell as tested for use with chemotherapy drugs.
- Hazardous Drug Handling: Do not substitute BASL for chemotherapy-tested gloves when the applicable hazardous-drug program requires such testing.
- USP <800> Applications: Select appropriate gloves that meet the applicable hazardous-drug handling requirements, including required chemotherapy testing and double-gloving procedures.
- Chemical Permeation: Review manufacturer chemical-permeation data for the specific substance and exposure conditions.
- Breakthrough Time: Laboratory permeation performance may not directly represent safe real-world wear time.
- Chemical Compatibility: Evaluate chemical concentration, temperature, duration, glove degradation, and potential exposure.
- Disinfectant Contact: Confirm compatibility with the facility's glove sanitization chemicals.
- Material Degradation: Replace gloves when swelling, tackiness, cracking, discoloration, or loss of mechanical integrity occurs.
- Task-Based PPE: Select the required glove material and protective performance for each chemical and process rather than relying solely on cleanroom classification.
Chemotherapy Glove Selection: Ansell does not identify BioClean Advance BASL as tested for chemotherapy drug handling. Facilities handling hazardous drugs should select gloves with the required documented chemotherapy-drug testing and chemical compatibility, consistent with their applicable safety standards and approved procedures.
Antistatic and ESD Considerations:
Ansell identifies BioClean Advance BASL as non-antistatic. Sterile cleanroom compatibility does not establish electrical resistance, static dissipation, or suitability for electrostatic-discharge-sensitive electronic components.
- Antistatic Classification: No
- ESD-Sensitive Operations: Evaluate gloves specifically designed and qualified for the relevant electrostatic-control requirements.
- Personnel Grounding: Maintain required wrist straps, footwear, flooring, and workstation controls under the facility ESD program.
- Material Qualification: Confirm glove electrical performance under the actual handling conditions where charge control is required.
- Cleanroom vs. ESD: Particle cleanliness and sterility do not independently establish electrostatic protection.
Size Selection and Manufacturer Ordering Codes:
BASL is available in seven sizes. Select the appropriate size when ordering to support a close fit, secure cuff placement, and precise hand movement during sterile operations.
- Size 6: BASL6.0
- Size 6.5: BASL6.5
- Size 7: BASL7.0
- Size 7.5: BASL7.5
- Size 8: BASL8.0
- Size 8.5: BASL8.5
- Size 9: BASL9.0
Fit Guidance: Oversized gloves can reduce tactile control and create excess material at the fingertips. Undersized gloves may restrict movement and increase material tension. When double-gloving, evaluate the complete glove combination rather than sizing each layer independently.
Packaging and Storage Recommendations:
- Inner Wallet: 1 pair per polyethylene wallet
- Individual Pouch: 1 wallet per sealed EasyTear® polyethylene pouch
- Outer Bag: 10 pouches per sealed polyethylene bag
- Case: 20 outer bags per lined carton
- Total Case Quantity: 200 sterile pairs
- Shelf Life: 5 years from date of manufacture
- Storage Conditions: Store in a cool, dry environment
- Sunlight Protection: Keep away from direct sunlight
- Ozone Protection: Avoid exposure to ozone sources that may degrade natural rubber latex
- Ignition Sources: Store away from ignition sources according to manufacturer guidance
- Expiration Control: Follow labeled expiration dates and facility stock-rotation procedures
- Package Integrity: Inspect sterile pouches before use and reject damaged packaging
- Lot Traceability: Retain lot information according to quality and receiving procedures
- Opened Packages: Follow aseptic gowning procedures and discard compromised or unused exposed gloves as required
- Disposal: Follow facility waste-management requirements
Manufacturer Technical Documents:
Ansell BioClean Advance BASL Manufacturer Product Information: Click Here
Ansell BioClean Advance BASL U.S. Product Data Sheet: Click Here
BioClean Advance BASL Product Data Sheet (SOSCleanroom PDF): Click Here
Ansell Regulatory Documentation and Chemical Permeation Information: Click Here
SOSCleanroom BioClean Advance BASL Product Information: Click Here
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Notes: Need assistance selecting sterile latex, nitrile, or neoprene cleanroom gloves? Open the SOSCleanroom Technical Vault tab above for additional information about glove selection, aseptic gowning, latex allergy considerations, cleanroom compatibility, double-gloving, and chemical-protection requirements.
SOSCleanroom.com supports pharmaceutical, biotechnology, semiconductor, laboratory, and other critical environments with sterile cleanroom gloves, protective apparel, cleaning products, and contamination-control consumables. Our team provides manufacturer documentation, product-selection assistance, packaging information, and procurement support.
Product description updated: October 19, 2026 (SOS Technical Staff)
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