Ansell BioClean Excell BEXS Sterile Nitrile Cleanroom Gloves - Class 10 / ISO 4 - 200 Pairs/Case
Ansell BioClean™ Excell BEXS sterile nitrile cleanroom gloves provide controlled hand protection for pharmaceutical manufacturing, biotechnology, aseptic processing, and other critical environments. These white, powder-free, natural rubber latex-free, and chemical accelerator-free gloves combine sterile presentation with cleanroom processing, chemical resistance, antistatic properties, and precise handling performance.
Designed for Class 10 / ISO Class 4 cleanrooms and EU GMP Grade A/B environments, BioClean Excell BEXS gloves feature a hand-specific design, textured fingers and palm, chlorinated interior, and beaded cuff. The approximately 300 mm (12-inch) length supports gown-to-glove overlap during controlled operations.
BEXS gloves are gamma sterilized to a Sterility Assurance Level (SAL) of 10-6 and packaged as individual sterile pairs in a multilayer protective configuration. Each case contains 200 pairs, with sizes 6 through 9 available, including half sizes.
Sterile Cleanroom Protection Advantage: BioClean Excell BEXS combines sterile nitrile protection, Class 10 / ISO 4 cleanroom compatibility, low particle contribution, antistatic properties, and controlled sterile packaging. Its latex-free, accelerator-free construction and textured grip make it a practical option for contamination-sensitive operations requiring dexterity, cleanroom material control, and documented glove performance.
Specifications:
- Manufacturer: Ansell
- Brand: BioClean™
- Product Family: BioClean Excell
- Model: BEXS
- Product Type: Sterile Disposable Nitrile Cleanroom Gloves
- Material: Nitrile
- Color: White
- Natural Rubber Latex: None
- Chemical Accelerators: Accelerator-free formulation
- Powder: Powder-free
- Cleanroom Classification: Class 10 / ISO Class 4
- Additional Cleanroom Applications: EU GMP 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
- Freedom from Holes: AQL 1.5, EN 374-2 testing
- Typical Particle Count: Less than 1,200 particles/cm² at ≥0.5 µm
- Particle Test Method: IEST-RP-CC005.4
- Antistatic: Yes
- Glove Shape: Hand-specific
- External Surface: Textured fingers and palm
- Internal Surface: Chlorinated
- Cuff Style: Beaded
- Typical Glove Length: 300 mm (12 inches)
- Target Palm Thickness: 0.14 mm (5.51 mil), single wall
- Target Finger Thickness: 0.17 mm (6.69 mil), single wall
- Target Cuff Thickness: 0.11 mm (4.33 mil), single wall
- Minimum Tensile Strength Before Aging: 15 MPa, ASTM D412-06a
- Natural Latex Protein Content: Not applicable; contains no natural rubber latex
- Chemical Protection: Manufacturer chemical-permeation information available for specified substances
- Chemotherapy Drug Protection: Manufacturer chemotherapy-permeation information available; verify individual drug, concentration, and tested exposure duration
- Available Sizes: 6, 6.5, 7, 7.5, 8, 8.5, 9
- Packaging: Individually pair-packed sterile presentation
- Case Quantity: 200 pairs
- Country of Origin: Malaysia
- Published Shelf Life: 5 years from date of manufacture
- Storage: Cool, dry conditions away from sunlight, ozone sources, and ignition sources
- Ordering Configuration: Case of 200 pairs; select the required size
About the Manufacturer:
Ansell develops personal protective equipment for pharmaceutical manufacturing, biotechnology, healthcare, laboratory research, electronics, medical devices, and other industrial and controlled environments. Its BioClean™ product family includes sterile and non-sterile gloves, cleanroom garments, and specialized protective products.
BioClean Excell BEXS gloves are manufactured using a latex-free, chemical accelerator-free nitrile formulation. They undergo clean processing, including deionized washing, to help control surface particulates, ionic extractables, and nonvolatile residues. Gamma sterilization and multilayer sterile packaging support use in critical contamination-control operations.
SOSCleanroom supports customers with Ansell glove selection, sterile gowning requirements, manufacturer documentation, size selection, packaging configurations, and procurement assistance for critical environments.
BioClean Excell BEXS Features:
- Sterile nitrile glove construction
- Class 10 / ISO Class 4 cleanroom compatibility
- Gamma sterilized to SAL 10-6
- AQL 1.5 freedom-from-holes performance
- Typical particle count below 1,200 particles/cm² at ≥0.5 µm
- Natural rubber latex-free and chemical accelerator-free formulation
- Powder-free construction
- Antistatic properties identified by Ansell
- Textured fingers and palm for secure grip
- Chlorinated interior for controlled donning
- Hand-specific design for improved fit and dexterity
- Beaded cuff for stable gown-to-glove overlap
- Approximately 300 mm glove length
- Deionized cleanroom washing to reduce particulate and residue contribution
- Individual sterile pair packaging
- Multilayer packaging designed for controlled transfer
- Published chemical and chemotherapy permeation documentation
- Five-year manufacturer shelf life
- Seven glove sizes
- 200 pairs per case
BioClean Excell BEXS Benefits:
- Sterile Presentation: Validated gamma sterilization and individually packaged pairs support approved aseptic gowning procedures.
- Critical Cleanroom Compatibility: Designed for use in demanding Class 10 / ISO 4 environments.
- Low Particle Contribution: Clean processing helps minimize particulate contamination transferred from the glove surface.
- Reduced Natural Latex Allergy Exposure: Nitrile construction eliminates natural rubber latex proteins from the glove material.
- Accelerator-Free Construction: Avoids added chemical accelerators commonly associated with certain glove-related Type IV sensitivities.
- Improved Dexterity: Hand-specific shaping supports accurate manipulation of instruments, containers, components, and laboratory tools.
- Controlled Grip: Textured fingers and palm provide tactile handling in appropriate wet and dry conditions.
- Antistatic Performance: Manufacturer-identified antistatic properties support applicable electrostatic-control selection programs.
- Gowning Compatibility: Approximately 12-inch length supports controlled glove and sleeve overlap.
- Quality Documentation: Published particle, sterility, hole-quality, and physical-property information supports material qualification.
- Chemical Selection Support: Manufacturer permeation data help facilities evaluate gloves against specified chemical and hazardous-drug exposures.
- Controlled Procurement: Standard 200-pair cases support recurring sterile glove programs.
Common Applications:
- Aseptic pharmaceutical manufacturing and processing
- ISO Class 4 cleanroom operations
- EU GMP Grade A/B manufacturing environments
- Sterile filling and packaging operations
- Biotechnology manufacturing and laboratory research
- Medical device manufacturing and sterile assembly
- Controlled handling of materials and components
- Cleanroom sampling and inspection
- Sterile processing and material preparation
- Restricted-access barrier system (RABS) support procedures
- Isolator material-transfer and support operations requiring separately donned sterile gloves
- Precision handling in contamination-sensitive environments
- Controlled chemical handling where documented glove compatibility is established
- Hazardous-drug handling only where the specific permeation data and facility requirements support the selected application
Best-Practice Use:
- Select the Correct Size: Choose a glove that provides secure fingertip control without excessive tension or loose material.
- Check the Expiration Date: Confirm that the selected pair remains within the labeled shelf life.
- Inspect Sterile Packaging: Verify that the pouch and protective packaging are intact before opening.
- Follow Material Transfer Procedures: Remove outer packaging in the appropriate controlled area according to the facility's approved procedures.
- Use Aseptic Donning: Avoid direct contact with the exterior glove surface during donning.
- Maintain Sleeve Coverage: Ensure proper overlap between glove cuffs and cleanroom garment sleeves.
- Inspect After Donning: Check for tearing, punctures, excessive stretching, or other defects.
- Control Surface Contact: Avoid touching uncontrolled equipment, packaging, or surfaces during sterile operations.
- Use Approved Glove Sanitization: Follow facility procedures for disinfectant selection, compatibility, application, and required contact time.
- Replace Compromised Gloves: Change gloves whenever integrity or sterility may have been affected.
- Follow Double-Gloving Requirements: Use an approved inner- and outer-glove configuration where required.
- Review Chemical Exposure: Confirm that the glove provides appropriate protection for any chemicals or hazardous drugs involved.
- Maintain Lot Traceability: Record product lot and expiration information where required by the quality system.
- Dispose Properly: Discard used gloves according to applicable contamination-control and waste-handling requirements.
Sterile Packaging and Controlled Transfer:
BioClean Excell BEXS gloves are packaged in a multilayer configuration designed to support controlled introduction into sterile environments. Each pair is protected by an inner wrap and pouch, with additional outer bags and lined case packaging.
- Inner Wrap: One glove pair per protective inner wrap.
- Individual Pouch: One wrapped pair per pouch.
- Outer Bag: Ten individually packaged pairs per outer bag.
- Case: Twenty outer bags per lined carton, totaling 200 sterile pairs.
- Receiving Area: Inspect shipping cartons and confirm the correct item, size, lot, and expiration information.
- Outer Packaging Removal: Remove shipping materials and unnecessary outer layers at the facility-designated transfer stages.
- Controlled Transfer: Use approved cleaning, disinfection, or transfer procedures for remaining package surfaces before entering more critical areas.
- Aseptic Opening: Open the individual pouch using the approved technique without touching the sterile glove exterior.
- Glove Presentation: Use the inner wrap to support controlled glove handling and prevent contact with nonqualified surfaces.
- Package Integrity: Reject pairs with torn, opened, wet, or otherwise compromised sterile packaging.
- Transfer Documentation: Follow facility procedures for product identification, lot traceability, material release, and gowning records.
Sterile Transfer Guidance: Multilayer packaging provides separate protective layers for material handling and controlled transfer. The packaging configuration should be integrated into the facility's approved gowning and contamination-control procedures. Sterility is maintained through proper package integrity, controlled opening, and aseptic handling at the point of use.
Sterility, AQL and Particle Control Explained:
BEXS gloves have published performance characteristics covering sterility, hole-quality classification, and particulate cleanliness. Each characteristic addresses a separate aspect of glove suitability for critical environments.
- Sterility Assurance Level (SAL 10-6): Describes the probability-based assurance associated with the validated gamma sterilization process.
- Gamma Irradiation: The manufacturer identifies a minimum sterilization dose of 25 kGy.
- AQL 1.5: Represents a standardized freedom-from-holes quality classification and does not guarantee that every glove is free from defects.
- Typical Particle Count: Below 1,200 particles/cm² for particles at least 0.5 µm in size under the stated manufacturer test method.
- Particle Testing: The manufacturer references IEST-RP-CC005.4 for typical particulate testing.
- Clean Processing: Deionized washing helps control particulates, ionic extractables, and nonvolatile residues.
- Operational Cleanliness: Actual contamination control depends on sterile transfer, donning technique, glove sanitization, change frequency, and work practices.
- Glove Integrity: Mechanical damage, punctures, and improper handling can compromise barrier performance after sterilization.
Cleanroom Performance Guidance: Sterility, glove integrity, and surface particle cleanliness are separate selection criteria. BEXS combines manufacturer-documented performance in these areas, but proper sterile gowning, material transfer, glove inspection, and change-out procedures remain essential to maintaining contamination control.
Chemical and Chemotherapy Permeation Selection:
BioClean Excell BEXS offers chemical-protection characteristics supported by manufacturer permeation documentation. Chemical resistance and chemotherapy-drug resistance must be evaluated using the specific substance, concentration, exposure duration, and conditions of the intended application.
- Chemical Permeation: Review manufacturer testing for the actual chemical or formulation being handled.
- Chemotherapy Permeation: Use the BEXS chemotherapy-permeation report to identify tested drugs, concentrations, and reported breakthrough behavior.
- Drug-Specific Selection: Performance against one chemotherapy drug does not establish equivalent resistance to other drugs or mixtures.
- Concentration: Confirm that the documented test concentration is appropriate for the intended hazardous-drug formulation.
- Breakthrough Time: Laboratory permeation results describe performance under defined test conditions and are not automatic safe-wear durations.
- Exposure Duration: Evaluate the expected contact time, task duration, and glove replacement frequency.
- Temperature: Higher temperatures may change permeation behavior and material performance.
- Physical Contact: Immersion, splash, repeated contact, and intermittent contamination represent different exposure conditions.
- Material Degradation: Inspect for swelling, discoloration, loss of elasticity, tackiness, or other chemical damage.
- Double-Gloving: Use the facility-required configuration for hazardous-drug handling or aseptic work, including appropriate outer-glove replacement intervals.
- USP <800> Programs: Where applicable, ensure the selected gloves meet the specific hazardous-drug handling requirements and documented chemotherapy-testing criteria.
- Glove Replacement: Follow the facility's glove-change procedures and replace gloves immediately after damage or contamination requiring removal.
Chemotherapy Protection Guidance: BEXS chemotherapy-permeation information should be interpreted for each tested drug and concentration. No single permeation result establishes universal protection against every hazardous drug. Select gloves using the manufacturer's applicable test documentation, required protection standards, the facility's hazardous-drug list, and approved glove-change procedures.
Antistatic and ESD Considerations:
Ansell identifies BioClean Excell BEXS as antistatic. This makes electrostatic behavior an additional factor in the glove's application profile, particularly for environments that combine contamination control with sensitive equipment or electronic components.
- Manufacturer Antistatic Classification: Yes
- Material: Nitrile formulation with manufacturer-identified antistatic characteristics
- ESD Workstations: Follow the facility's grounding, material-selection, and personnel-control requirements.
- Glove Qualification: Confirm that the specific glove meets the required electrical resistance or charge-control criteria for the application.
- Handling Conditions: Moisture, surface contamination, glove fit, and contact materials can influence electrostatic performance.
- Personnel Grounding: Antistatic gloves do not replace approved wrist straps, footwear, flooring, or workstation grounding systems.
- Static-Sensitive Equipment: Apply the full ESD program where required by component sensitivity and facility procedures.
ESD Selection Guidance: BioClean Excell BEXS is manufacturer-designated as antistatic. For applications with defined ESD performance requirements, confirm the required electrical characteristics and evaluate the glove within the complete grounding and handling system.
Latex-Free and Accelerator-Free Material Selection:
BEXS gloves are made from nitrile without natural rubber latex or added chemical accelerators. This construction can be beneficial for facilities seeking to reduce exposure to natural latex proteins and selected accelerator-related sensitizers.
- Natural Latex-Free: Contains no natural rubber latex proteins.
- Accelerator-Free: Manufactured without added chemical vulcanization accelerators associated with certain contact sensitivities.
- Powder-Free: Eliminates glove powder as a potential particulate source.
- Operator Comfort: Hand-specific shaping and the chlorinated interior support controlled donning and precise work.
- Allergy Management: Nitrile and accelerator-free construction can reduce exposure to selected allergens but do not eliminate every possible skin sensitivity.
- Process Compatibility: Review formulation and material suitability for the facility's products, chemicals, and surfaces.
Size Selection and Manufacturer Ordering Codes:
BioClean Excell BEXS is available in seven sizes. Select the appropriate size to support controlled handling, finger dexterity, and secure fit during aseptic operations.
- Size 6: BEXS-60
- Size 6.5: BEXS-65
- Size 7: BEXS-70
- Size 7.5: BEXS-75
- Size 8: BEXS-80
- Size 8.5: BEXS-85
- Size 9: BEXS-90
Fit Guidance: Oversized gloves may reduce fingertip control and increase unwanted material movement. Undersized gloves may restrict movement or place additional stress on the glove material. Evaluate fit while performing the actual task and when wearing any required inner glove.
Packaging and Storage Recommendations:
- Inner Wrap: 1 pair
- Individual Pouch: 1 wrapped pair
- Outer Bag: 10 individually packaged pairs
- Case: 20 outer bags per lined carton
- Total Case Quantity: 200 pairs
- Shelf Life: 5 years from date of manufacture
- Lot-Specific Expiration: Follow the expiration information on the supplied product packaging
- Storage Conditions: Cool, dry environment
- Sunlight Protection: Keep away from direct sunlight
- Ozone Protection: Avoid storage near ozone-producing equipment or sources
- Ignition Sources: Store away from ignition sources according to manufacturer guidance
- Package Integrity: Inspect pouches and protective bags before use
- Controlled Transfer: Follow facility procedures for removing outer packaging and introducing sterile supplies into cleanroom areas
- Lot Traceability: Record manufacturer lot and expiration information where required
- Stock Rotation: Use approved first-expiring-first-out procedures
- Opened Packaging: Maintain sterile handling discipline and discard compromised pairs
- Disposal: Follow facility requirements for used gloves and any associated chemical or hazardous-drug contamination
Manufacturer Technical Documents:
Ansell BioClean Excell BEXS U.S. Product Data Sheet: Click Here
BioClean Excell BEXS Product Data Sheet (SOSCleanroom PDF): Click Here
Ansell BioClean Sterile Cleanroom Gloves and Manufacturer Resources: Click Here
SOSCleanroom BioClean Excell BEXS Product Information: Click Here
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Notes: Need assistance selecting sterile nitrile gloves for ISO 4 cleanrooms, comparing BioClean Excell BEXS with BioClean Emerald BENS, or reviewing chemical and chemotherapy permeation requirements? Open the SOSCleanroom Technical Vault tab above for additional information about aseptic gowning, sterile packaging transfer, glove integrity, antistatic properties, and chemical-protection selection.
SOSCleanroom.com supports pharmaceutical, biotechnology, semiconductor, medical device, laboratory, and other critical environments with sterile cleanroom gloves, protective apparel, cleaning products, and specialized contamination-control consumables. Our team provides product selection assistance, manufacturer documentation, packaging information, and procurement support.
Product description updated: October 19, 2026 (SOS Technical Staff)
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