Ansell BioClean Emerald BENS Sterile Nitrile Cleanroom Gloves - Class 10 / ISO 4 - 200 Pairs/Case
Ansell BioClean™ Emerald BENS sterile nitrile cleanroom gloves are designed for critical contamination-controlled environments requiring sterile hand protection, controlled particulate levels, chemical resistance, and precision handling. Manufactured from green, powder-free nitrile without natural rubber latex or chemical accelerators, these gloves provide comfortable protection for pharmaceutical manufacturing, biotechnology, laboratory operations, and aseptic processing.
BioClean Emerald BENS gloves are suitable for Class 10 / ISO Class 4 cleanroom applications and EU GMP Grade A/B environments, subject to facility qualification. They feature a hand-specific design, smooth exterior with micro-textured finish, chlorinated interior, and beaded cuff. The approximately 300 mm length supports secure overlap between glove cuffs and cleanroom garments.
Each glove pair is gamma sterilized to a Sterility Assurance Level (SAL) of 10-6 and supplied in protective multilayer packaging for controlled introduction into sterile environments. BENS gloves are also tested for resistance to specified chemotherapy drugs under ASTM D6978, making them an option for hazardous-drug programs when the manufacturer's drug-specific permeation data support the application.
Sterile Cleanroom Protection Advantage: BioClean Emerald BENS combines sterile nitrile construction, ISO Class 4 cleanroom compatibility, AQL 1.5, antistatic properties, low particle contribution, and documented chemotherapy-drug permeation testing. Its latex-free, accelerator-free formulation and individual sterile pair packaging support controlled gowning and chemical-protection programs in critical environments.
Specifications:
- Manufacturer: Ansell
- Brand: BioClean™
- Product Family: BioClean Emerald
- Model: BENS
- Product Type: Sterile Disposable Nitrile Cleanroom Gloves
- Material: Nitrile
- Color: Green
- Natural Rubber Latex: None
- Chemical Accelerators: Accelerator-free
- 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
- 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
- Exterior Surface: Smooth with micro-textured finish
- Interior Surface: Chlorinated
- Cuff Style: Beaded
- Typical Glove Length: 300 mm (12 inches)
- Target Palm Thickness: 0.11 mm (4.33 mil), single wall
- Target Finger Thickness: 0.15 mm (5.90 mil), single wall
- Target Cuff Thickness: 0.08 mm (3.15 mil), single wall
- Minimum Ultimate Tensile Strength Before Aging: 15 MPa
- Force at Break Before Aging: At least 6 N, EN 455-2
- Chemotherapy Drug Testing: Yes, ASTM D6978
- Chemotherapy Permeation Test Endpoint: 0.01 µg/cm²/min
- Chemical Protection: PPE Category III, EN ISO 374-1 Type B
- Double-Gloving: Suitable for use as an underglove in approved double-gloving procedures
- 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: Dry conditions in original packaging, protected from sunlight and ozone sources
- Ordering Configuration: Case of 200 pairs; select required glove size
About the Manufacturer:
Ansell develops protective gloves and apparel for pharmaceutical manufacturing, biotechnology, laboratory research, medical devices, healthcare, electronics, and other critical environments. Its BioClean™ portfolio includes sterile and non-sterile gloves, cleanroom garments, and specialized protective products.
BioClean Emerald BENS gloves combine accelerator-free nitrile construction with cleanroom processing, deionized washing, gamma sterilization, and controlled packaging. These manufacturing processes support low surface particulate levels, controlled ionic extractables, and consistent sterile presentation.
SOSCleanroom supports customers with Ansell product selection, sterile glove sizing, chemical-permeation documentation, manufacturer specifications, and procurement assistance for contamination-sensitive environments.
BioClean Emerald BENS Features:
- Sterile nitrile glove construction
- Class 10 / ISO Class 4 cleanroom compatibility
- Gamma sterilized to SAL 10-6
- AQL 1.5 freedom-from-holes classification
- Typical particle count below 1,200 particles/cm² at ≥0.5 µm
- Natural rubber latex-free formulation
- Chemical accelerator-free construction
- Powder-free
- Manufacturer-designated antistatic properties
- Hand-specific ergonomic fit
- Smooth exterior with micro-textured grip
- Chlorinated interior for controlled donning
- Beaded cuff for secure gown overlap
- Approximately 300 mm overall glove length
- Deionized cleanroom washing to reduce surface contamination
- Individually packaged sterile pairs
- Multilayer polyethylene packaging
- ASTM D6978 chemotherapy-drug permeation testing
- Suitable for approved double-gloving configurations
- Five-year published shelf life
- Seven manufacturer sizes
- 200 pairs per case
BioClean Emerald BENS Benefits:
- Sterile Presentation: Gamma sterilization and individually packaged pairs support approved aseptic gowning procedures.
- Critical Cleanroom Compatibility: Designed for Class 10 / ISO 4 and suitable critical sterile manufacturing environments.
- Low Particle Contribution: Controlled washing helps reduce surface particulates, ionic residues, and nonvolatile contaminants.
- Latex-Free Protection: Nitrile construction avoids exposure to natural rubber latex proteins.
- Accelerator-Free Formulation: Helps reduce exposure to certain chemical accelerators associated with Type IV contact sensitivities.
- Precision Handling: Hand-specific construction supports dexterity during detailed aseptic tasks.
- Controlled Grip: Micro-textured surface supports handling of tools, containers, and components.
- Antistatic Design: Manufacturer-designated antistatic properties support applicable electrostatic-control selection requirements.
- Documented Chemical Performance: ASTM D6978 chemotherapy permeation results support drug-specific glove selection.
- Double-Gloving Compatibility: Chlorinated interior and ergonomic design support use as an underglove where required.
- Material Traceability: Manufacturer packaging and labeling support receiving, quality control, and lot management.
- Controlled Procurement: Standard 200-pair case packaging supports recurring sterile glove requirements.
Common Applications:
- Aseptic pharmaceutical manufacturing
- Sterile filling and packaging operations
- ISO Class 4 contamination-controlled environments
- EU GMP Grade A/B manufacturing operations
- Biotechnology production and research
- Medical device manufacturing and sterile assembly
- Controlled laboratory sampling and inspection
- Sterile material preparation and transfer
- Pharmaceutical compounding where the glove meets the applicable process requirements
- Hazardous-drug handling where drug-specific permeation data support use
- Double-gloving procedures for approved sterile operations
- Cleaning and sanitization procedures requiring compatible sterile nitrile gloves
- Precision manipulation of contamination-sensitive components
- Controlled chemical handling with verified material compatibility
Best-Practice Use:
- Select the Correct Size: Choose a secure fit that supports finger movement without excessive stretching.
- Inspect Packaging: Check the sterile pouch and protective packaging before use.
- Verify Expiration: Confirm the glove pair is within the manufacturer-labeled expiration date.
- Follow Controlled Transfer: Remove outer packaging at the appropriate stage of the facility's cleanroom transfer process.
- Use Aseptic Donning: Avoid touching the sterile glove exterior with nonqualified surfaces.
- Maintain Gown Overlap: Ensure appropriate glove-to-sleeve coverage during all working movements.
- Double-Glove When Required: Follow the approved sequence for inner and outer gloves.
- Inspect After Donning: Check for visible damage, punctures, tears, or excessive tension.
- Use Approved Glove Sanitization: Follow facility procedures for sanitizing gloved hands.
- Replace Damaged Gloves: Change gloves immediately when integrity or sterility is compromised.
- Control Task Changes: Replace gloves when moving between operations or contamination zones according to the approved SOP.
- Review Chemical Exposure: Verify the glove's resistance to the actual chemicals and hazardous drugs used.
- Maintain Lot Traceability: Record product identification and expiration information where required.
- Dispose Properly: Follow applicable procedures for potentially contaminated glove disposal.
Sterile Packaging and Controlled Transfer:
BioClean Emerald BENS gloves use multilayer protective packaging to support controlled introduction into sterile manufacturing environments. Each pair is individually wrapped and pouched, with additional outer-bag and case protection.
- Inner Wrap: One pair per protective inner wrap.
- Individual Pouch: One wrapped pair per pouch.
- Outer Bag: Ten individually pouched pairs.
- Case: Twenty outer bags per lined carton.
- Total Packaging: 200 individually packaged sterile pairs per case.
- Receiving Inspection: Verify case integrity, product identity, size, lot number, and expiration date.
- Outer Packaging Removal: Remove shipping materials and designated protective layers in the appropriate preparation area.
- Material Transfer: Follow approved procedures for cleaning or disinfecting the remaining packaging surfaces before entering higher-classification areas.
- Pouch Opening: Open sterile packaging using controlled handling techniques to prevent contact with the glove exterior.
- Inner Wrap: Use the protective wrap to assist aseptic donning.
- Package Integrity: Reject damaged, wet, opened, or otherwise compromised sterile packaging.
- Lot Control: Maintain traceability through receiving, transfer, and point-of-use procedures where required.
Sterile Transfer Guidance: The multilayer packaging is intended to support controlled material transfer and aseptic glove presentation. Each facility should define where packaging layers are removed, how remaining package surfaces are handled, and how sterile gloves are introduced at the point of use. Follow established gowning and contamination-control procedures throughout the transfer process.
Sterility, AQL and Particle Control Explained:
- Sterility Assurance Level: SAL 10-6 is associated with the validated gamma sterilization process.
- Gamma Irradiation: Manufacturer-published minimum sterilization dose of 25 kGy.
- AQL 1.5: Standardized freedom-from-holes quality classification under EN 374-2.
- Particle Control: Typical particle count below 1,200 particles/cm² at ≥0.5 µm.
- Testing Method: IEST-RP-CC005.4 for published particulate performance.
- Deionized Washing: Helps reduce ionic extractables, surface particulate contamination, and nonvolatile residue.
- Handling Controls: Glove cleanliness depends on proper packaging transfer, aseptic donning, controlled contact, sanitization, and replacement practices.
- Glove Integrity: Tears, punctures, and mechanical damage can compromise protection during use.
Cleanroom Performance Guidance: Sterility, freedom from holes, and particle cleanliness represent different performance characteristics. BioClean Emerald BENS provides documented performance in these areas, while proper gowning technique, glove inspection, sanitization, and defined replacement practices remain essential to contamination control.
ASTM D6978 Chemotherapy Permeation Performance:
Ansell provides third-party laboratory chemotherapy permeation results for BioClean Emerald BENS under ASTM D6978. The published testing identifies breakthrough times for specific chemotherapy drugs at defined concentrations, using a permeation rate of 0.01 µg/cm²/min.
The following results are taken from the manufacturer's BioClean Emerald BENS chemotherapy permeation report.
| Chemotherapy Drug |
Test Concentration |
Breakthrough Time |
| Capecitabine |
26.0 mg/mL |
>240 minutes |
| Carboplatin |
10.0 mg/mL |
>240 minutes |
| Carmustine |
3.3 mg/mL |
128.6 minutes |
| Cisplatin |
1.0 mg/mL |
>240 minutes |
| Cyclophosphamide |
20.0 mg/mL |
>240 minutes |
| Docetaxel |
10.0 mg/mL |
>240 minutes |
| Doxorubicin HCl |
2.0 mg/mL |
>240 minutes |
| Epirubicin HCl |
2.0 mg/mL |
>240 minutes |
| Etoposide |
20.0 mg/mL |
>240 minutes |
| Fluorouracil |
50.0 mg/mL |
>240 minutes |
| Gemcitabine |
38.0 mg/mL |
>240 minutes |
| Irinotecan |
20.0 mg/mL |
>240 minutes |
| Mitoxantrone HCl |
2.0 mg/mL |
>240 minutes |
| Oxaliplatin |
5.0 mg/mL |
>240 minutes |
| Paclitaxel |
6.0 mg/mL |
>240 minutes |
| Rituximab |
10.0 mg/mL |
>240 minutes |
| Thiotepa |
10.0 mg/mL |
>240 minutes |
| Vinorelbine |
10.0 mg/mL |
>240 minutes |
Test Method: ASTM D6978, third-party accredited laboratory. The reported breakthrough threshold is 0.01 µg/cm²/min. Results are specific to the tested drug, concentration, and laboratory conditions.
Chemotherapy Protection Guidance: BENS is tested against the specific chemotherapy drugs and concentrations shown above. The breakthrough results are laboratory measurements, not approved glove-wear durations. A result of greater than 240 minutes does not mean gloves should be worn for four hours during hazardous-drug handling. Actual protection depends on the drug formulation, exposure type, glove condition, temperature, and facility PPE procedures. Follow the applicable hazardous-drug glove-change requirements and the facility's approved SOP.
Hazardous-Drug Glove-Change Procedures:
Chemotherapy glove selection must account for both chemical permeation performance and actual exposure during preparation, administration support, cleaning, spill response, and other hazardous-drug activities. The facility's glove-change procedure should establish when gloves must be replaced regardless of the manufacturer's laboratory breakthrough results.
- Double-Gloving: Use two pairs of appropriate chemotherapy gloves where required by the applicable hazardous-drug handling standards and workplace procedures.
- Routine Change Frequency: For USP <800> hazardous-drug compounding, change chemotherapy gloves at least every 30 minutes unless the applicable manufacturer's instructions require more frequent replacement.
- Immediate Replacement: Replace gloves immediately if torn, punctured, visibly contaminated, or otherwise compromised.
- After Drug Contact: Follow the facility's procedure for immediate glove replacement after spills, splashes, or contamination events.
- Task Changes: Change gloves at defined transitions between operations, materials, or contamination zones.
- Outer-Glove Replacement: Follow the procedure for safely removing and replacing an outer glove without contaminating the inner glove or sterile work area.
- Inner-Glove Inspection: Assess the inner glove after outer-glove removal and replace it when required by the procedure or suspected contamination.
- Hand Hygiene: Perform hand hygiene according to the relevant gowning and hazardous-drug procedures after glove removal.
- Cleaning and Sanitization: Use only approved glove sanitization procedures compatible with the nitrile material and the work being performed.
- Drug-Specific Limits: Review the manufacturer's chemotherapy permeation information when the drug or formulation changes.
- Documented SOP: Establish clear glove-change intervals, replacement triggers, double-gloving instructions, and waste-handling requirements.
Glove-Change Principle: Laboratory breakthrough times establish material permeation performance under defined conditions. They do not replace required glove-change intervals. During hazardous-drug compounding, facilities subject to USP <800> should follow the applicable chemotherapy-glove change frequency, replace compromised or contaminated gloves immediately, and maintain documented double-gloving procedures.
Chemical Compatibility and Use Limitations:
- Drug-Specific Testing: ASTM D6978 results apply only to the tested drugs, concentrations, and conditions.
- Untested Drugs: Do not assume equivalent chemical resistance for chemotherapy drugs that are not included in the published testing.
- Drug Mixtures: Mixtures and formulations may change permeation performance compared with testing of individual substances.
- Carmustine: The published breakthrough time is 128.6 minutes at 3.3 mg/mL, rather than greater than 240 minutes.
- Breakthrough Time: A reported laboratory breakthrough time is not a recommended maximum wearing period.
- Repeated Exposure: Repeated splashes, wiping, contact with contaminated surfaces, and other work activities may affect performance.
- Material Degradation: Swelling, discoloration, tackiness, or loss of elasticity can indicate chemical incompatibility.
- Mechanical Damage: Cuts, punctures, excessive stretching, and abrasion can compromise barrier performance.
- Disinfectant Compatibility: Verify suitability for the facility's approved glove sanitization chemicals and contact conditions.
- Thermal Exposure: Elevated temperatures may influence permeation and material behavior.
- Hazard Assessment: Select glove material according to the actual chemical hazards, handling procedures, and applicable standards.
Antistatic and ESD Considerations:
Ansell identifies BioClean Emerald BENS as antistatic. This characteristic can be relevant in controlled environments where static accumulation, particle attraction, and sensitive equipment handling are operational considerations.
- Manufacturer Antistatic Classification: Yes
- Cleanroom Operations: Antistatic properties may support contamination-control procedures where electrostatic behavior is relevant.
- ESD Workstations: Follow required facility grounding and equipment-control procedures.
- Electrical Qualification: Confirm the glove's electrical properties against any defined ESD application requirements.
- Personnel Grounding: Antistatic gloves do not replace appropriate wrist straps, footwear, flooring, or other ESD controls.
- Handling Conditions: Surface moisture, chemical residues, contact materials, and environmental conditions can influence electrostatic behavior.
- Process Selection: Evaluate antistatic performance separately from glove sterility, particle cleanliness, and chemical protection.
Latex-Free and Accelerator-Free Construction:
- Natural Rubber Latex-Free: Nitrile construction contains no natural rubber latex proteins.
- Chemical Accelerator-Free: Manufactured without added chemical accelerators used in some glove formulations.
- Powder-Free: Eliminates added glove powder as a contamination source.
- Operator Comfort: Hand-specific construction and chlorinated interior support precision handling and frequent glove changes.
- Allergy Management: Latex-free and accelerator-free construction can reduce exposure to selected sensitizers but does not eliminate all possible glove-related skin reactions.
- Material Qualification: Review formulation compatibility where chemicals, product-contact requirements, or process contaminants are critical.
Size Selection and Manufacturer Ordering Codes:
BioClean Emerald BENS is available in seven manufacturer sizes. Select the appropriate size for secure fingertip control, comfortable movement, and proper fit when double-gloving.
- Size 6: BENS-6.0
- Size 6.5: BENS-6.5
- Size 7: BENS-7.0
- Size 7.5: BENS-7.5
- Size 8: BENS-8.0
- Size 8.5: BENS-8.5
- Size 9: BENS-9.0
Fit Guidance: Oversized gloves may reduce fingertip control and create excess material around instruments or components. Undersized gloves can restrict movement and increase stress on the material. Evaluate the complete fit when wearing two glove layers.
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 manufacture
- Lot-Specific Expiration: Follow the labeled expiration date on the supplied packaging
- Storage: Keep in original packaging in a dry environment
- Sunlight Protection: Avoid direct sunlight
- Ozone Protection: Keep away from ozone-generating equipment
- Package Integrity: Inspect protective packaging before sterile transfer or gowning
- Packaging Materials: Polyethylene-based inner wrap, pouch, bag, and liner
- Recyclability: Polyethylene packaging may be recyclable where local facilities accept the material
- Shipping Case: Manufacturer identifies recycled cardboard shipper packaging
- Lot Traceability: Record required product identification and expiration information
- Stock Rotation: Follow first-expiring-first-out procedures where applicable
- Opened Packaging: Maintain sterile handling discipline and discard compromised pairs
- Disposal: Handle contaminated gloves according to the facility's chemical and hazardous-drug waste procedures
Manufacturer Technical Documents:
Ansell BioClean Emerald BENS Product Data Sheet (PDF): Click Here
Ansell BioClean Emerald BENS Chemotherapy Permeation Report - ASTM D6978 (PDF): Click Here
SOSCleanroom BioClean Emerald BENS Product Information: Click Here
Other Similar Products Available From SOSCleanroom.com
Sterile Nitrile Cleanroom Gloves
Sterile Latex Alternative
Compatible Contamination-Control Consumables
Notes: Need assistance selecting sterile nitrile gloves for ISO 4 cleanrooms, comparing BENS and BEXS, or reviewing chemotherapy permeation requirements? Open the SOSCleanroom Technical Vault tab above for additional information about aseptic gowning, controlled material transfer, double-gloving, glove-change procedures, antistatic properties, and chemical protection.
SOSCleanroom.com supports pharmaceutical, biotechnology, semiconductor, laboratory, medical device, and other critical environments with sterile cleanroom gloves, protective apparel, cleaning products, and specialized 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)
© 2026 SOS Supply. All rights reserved.
