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Ansell BENS BioClean Emerald Sterile Nitrile Gloves Class 10 (ISO 4)

Ansell BENS BioClean Emerald Nitrile Gloves Sterile Class 10 (ISO 4)

$834.30
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SKU:
BENS
Availability:
7 - 10 Business Days
Shipping:
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Quantity Option (Case):
200 Pairs
Inner Packaging:
See Below
Ansell BioClean™ Emerald BENS Sterile Nitrile Cleanroom Gloves — Class 10 / ISO 4 Chemo-Rated Protection with Accelerator-Free Comfort and Sustainable Packaging
Class 10 / ISO 4 Sterile (SAL 10-6) Nitrile (latex-free) Accelerator-free Powder-free Chemo-tested (ASTM D6978) Anti-static 12" length Green 200 pairs / case
Product overview
BioClean™ Emerald BENS is a sterile, single-use nitrile cleanroom glove designed for Class 10 / ISO 4 and EU GMP Grade A/B sterile operations where glove performance, documentation, and contamination control discipline must hold up under audit pressure. BENS combines a smooth glove body with a micro-textured finish for controlled grip, a chlorinated internal surface for more consistent donning, and a hand-specific shape to support dexterity during skilled handling and aseptic workflows.

BENS is also part of the BioClean chemotherapy-rated glove line and is tested for use with chemotherapy drugs. Packaging is engineered for both clean introduction and sustainability goals: sterile gloves are packed in recyclable plastic with recycled cardboard shipper cases (always confirm local recycling capability for polyethylene film, as acceptability varies by region).
Why customers choose Emerald BENS
  • Built for Class 10 / ISO 4 and sterile cleanrooms, aligning glove selection with risk-based contamination control where gloves are a primary product-contact risk.
  • Sterile by gamma irradiation with a published Sterility Assurance Level (SAL) of 10-6, supporting critical zone handling and sterile processing discipline.
  • Accelerator-free, powder-free, and latex-free nitrile formulation helps reduce Type I latex and Type IV chemical allergy concerns while maintaining controlled-environment performance.
  • Chemo-tested barrier intent for hazardous drug handling programs where chemotherapy permeation performance and documentation matter (follow your facility’s hazardous drug procedures and glove change frequency requirements).
  • Hand-specific ergonomic shape supports dexterity and reduces fatigue during repetitive aseptic tasks, sampling, and skilled manipulation.
  • Smooth surface with micro-textured finish supports controlled grip without the “sticky” feel some aggressive textures can introduce in sterile handling.
  • Clean processed and deionized washed to reduce surface particulates, ionic extractables, and non-volatile residues (NVR) for cleaner downstream outcomes.
  • Designed to be double-donned and commonly positioned as an underglove for double-gloving workflows.
  • More sustainable packaging approach: recyclable plastic packaging and recycled cardboard shipper cases (verify local PE film recycling availability).
Recommended applications
  • Aseptic filling, processing, and labeling steps where sterility assurance and consistent glove integrity are required
  • Sterile processing departments and clean transfer operations (material movement, staging, and controlled introduction)
  • Pharmaceutical and biotech manufacturing tasks (blending operations, sampling, transferring liquids and solids)
  • Hazardous drug / chemotherapy handling workflows where chemotherapy testing and change-frequency discipline are part of the safety program
  • Chemical handling and splash-risk tasks where nitrile chemical resistance is part of the selection logic (confirm compatibility against your chemical list)
  • Medical device manufacturing and laboratory research where both contamination control and operator protection are required
Note: Sterile glove performance in real operations depends on technique (donning/doffing, glove change frequency, and touch discipline) as much as glove specification. Validate glove selection and change timing in your process, especially for hazardous drug handling and aseptic manipulations.
Specifications (from published technical data)
SKU BENS
Cleanroom classification Class 10 / ISO Class 4 & EU GMP Grade A/B and other sterile cleanrooms
Material / color Nitrile / Green
Powder content Powder-free
External glove surface Smooth with micro-textured finish
Internal glove surface Chlorinated
Shape Hand specific
Cuff Beaded; cuff length: Standard
Typical glove length 300 mm / 12 in
Freedom from holes (AQL) 1.5 AQL Performance
Thickness targets (single wall) Palm: 0.11 mm / 4.33 mil
Finger: 0.15 mm / 5.90 mil
Cuff: 0.08 mm / 3.15 mil
Typical particle level (cleanroom metric) ≥0.5 µm: < 1,200 counts / cm2
Anti-static Yes
Sterility Sterile; SAL 10-6
Sterilization method Gamma irradiation; published minimum dose 25 kGy
Tested for use with chemotherapy drugs Yes
Available sizes 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0
Reorder numbers BENS-6.0, BENS-6.5, BENS-7.0, BENS-7.5, BENS-8.0, BENS-8.5, BENS-9.0
Packaging (case) 1 pair per inner wrap; 1 inner wrap per pouch; 10 pouches per outer bag; 20 outer bags per lined carton (200 pairs)
(More sustainable packaging: recyclable plastic packaging and recycled cardboard shipper cases; inner wrap, pouch, bag, and liner use polyethylene (PE) film. Always verify local recycling options for PE.)
Shelf life Five (5) years from date of manufacture
Storage guidance Keep away from direct sunlight; store in a dry place in the original packaging; keep away from ozone sources.
Country of origin Malaysia
Test method context (as published): typical particle count references IEST-RP-CC005.4; length and thickness targets reference EN ISO 21420; freedom from holes references EN 374-2. Always validate glove selection in your process, including chemical compatibility, product-contact risk, and operator technique.
Cleanroom program guidance (U.S. first, global context second)
In U.S.-based cleanrooms and regulated manufacturing, sterile gloves are treated as a primary contamination control and mix-up risk at the point of use. Build glove selection and use into your quality system: defined gowning sequence, controlled donning/doffing, documented glove change frequency at critical steps, and clear handling rules for product-contact surfaces. Many U.S. programs use ISO 14644 cleanroom terminology alongside FDA expectations and facility contamination control strategy (CCS) practices. In sterile compounding and hazardous drug workflows, teams often align technique, change frequency, and documentation discipline to USP <797> and USP <800> intent (as applicable to the operation).
As a secondary/global benchmark, EU GMP Annex 1 reinforces risk-based CCS thinking: material transfer discipline, glove integrity/changes at critical steps, and documentation that supports investigation readiness. Use it as a continuous improvement lens where it fits your business, without treating it as a U.S. legal requirement.
Helpful standards and guidance hubs (for program reference): https://www.iso.org/standard/53394.html  |  https://www.fda.gov  |  https://www.astm.org  |  https://www.iest.org
Build a best-in-class ISO 4 consumables set
SOSCleanroom does not compromise on glove quality in critical environments. Ansell is our best-in-class glove line for customers who need consistent controlled-environment performance and documentation discipline. To reduce overall contamination risk in ISO 4 spaces, match your glove choice with wiping and swabbing materials that are engineered for the same environment and the same level of traceability.
Texwipe pairing suggestion (ISO 4-aligned wiping and swabbing)
For over 35 years, SOS and Texwipe have been close partners, and SOSCleanroom is the authorized Master Distributor of ITW Texwipe for the United States market. In ISO Class 4 programs, many teams standardize a sealed-edge/sterile wipe set for critical touch-downs and disinfectant application, then add a sterile swab for grooves, ports, and tight geometries where wipes cannot maintain consistent contact.
  • Dry wipe-downs and controlled cleaning strokes: Texwipe TX8659 Vectra Alpha10 LT 9" x 9" polyester wipers (low-linting; note that no wiper is truly “zero-lint” in every process condition). https://www.soscleanroom.com/product/wipers/texwipe-tx8659-vectra-alpha10-lt-9-x-9-polyester-cleanroom-wiper/
  • Sterile pre-wetted critical wipe-downs: Texwipe STX1704P Sterile Revolve 4" x 4" pre-wetted 70% IPA wipers (sterile and ISO-class listed on the product page). https://www.soscleanroom.com/product/wipers/texwipe-stx1704p-sterile-revolve-4-x-4-upcycled-polyester-cleanroom-wiper-pre-wetted-70-ipa/
  • Precision swabbing for tight features: Texwipe STX758B sterile micro polyester knit swab for grooves, slots, ports, and controlled sampling/cleaning workflows (verify fit and cleanliness requirements for your application). https://www.soscleanroom.com/product/swabs/texwipe-stx758b-sterile-micro-alpha-polyester-cleanroom-swab/
About Ansell and SOSCleanroom supply confidence
Ansell is a global manufacturer of hand and body protection solutions with strong controlled-environment product lines used across life sciences, electronics, and critical manufacturing. In sterile cleanrooms, consistency matters: formulation control, clean processing, sterile packaging discipline, and the ability to support documentation requests when quality teams need to qualify and sustain a glove program.
SOSCleanroom supports customers who need dependable, best-in-class cleanroom consumables with fast shipping, excellent customer service, fair pricing, and continuity of supply backed by 40+ years serving controlled environments. As a third-party validation point, Cleanroom Technology reported that SOS Cleanroom Supply became an Ansell authorised distributor (June 20, 2023): https://www.cleanroomtechnology.com/sos-cleanroom-supply-becomes-ansell-authorised-distributor-209576
Documentation
Product Data Sheet (PDS) – SOSCleanroom hosted (stable): bioclean-emerald-bens_pds_us.pdf
Declaration of Conformity – SOSCleanroom hosted: BioClean Emerald BENS – EU Declaration of Conformity (PDF)
Chemical Permeation Summary – SOSCleanroom hosted: Chemical Permeation Report Summary (BENS) (PDF)
Chemotherapy Permeation Summary – SOSCleanroom hosted: Chemotherapy Permeation Brochure (BENS) (PDF)
Manufacturer hosted PDS (reference): Ansell PDS (BioClean Emerald BENS)
Manufacturer hosted chemotherapy permeation summary (reference): Ansell chemotherapy permeation brochure (BENS)
Manufacturer hosted chemical permeation summary (reference): Ansell chemical permeation report summary (BENS)
If you have any questions please email us at Sales@SOSsupply.com or give us a call at (214)340-8574.
If you need additional information please try our SOSCleanroom specific AI ChatBot which draws from our extensive cleanroom specific libraries.
Last updated: January 10, 2026
© 2026 SOSCleanroom.com
The Technical Vault
By SOSCleanroom
Ansell BioClean™ Emerald BENS Sterile Nitrile Cleanroom Gloves — Class 10 / ISO 4, Chemo-Rated Barrier Protection with Sustainability-Minded Packaging
Class 10 / ISO 4 Sterile (SAL 10-6) Chemo-rated (ASTM D6978) Accelerator-free Anti-static 200 pairs / case
1. Practical solutions in a critical environment

When your risk profile includes both contamination control and exposure potential (chemicals or cytotoxic drugs), glove selection becomes part of the contamination control strategy — not a commodity purchase. BioClean™ Emerald BENS is positioned for sterile cleanrooms where teams need sterile presentation, controlled particle contribution, and a defensible barrier story for chemical and chemotherapy handling.

Operationally, BENS is frequently selected for double-don workflows (often as an underglove) where ease of donning, predictable fit, and lot traceability support consistent technique and investigation readiness when deviations occur.

2. What this glove is for
  • Aseptic filling, processing, and labeling steps where sterile presentation and glove integrity are required
  • Sterile processing departments and clean transfer operations (material staging, controlled introduction, and point-of-use handling)
  • Hazardous drug / chemotherapy handling programs where permeation data and disciplined change frequency are part of the safety program
  • Pharmaceutical, biotech, and medical device tasks requiring both contamination control and operator protection
3. Selection rationale
  • Sterile ISO 4 fit: Selected for Class 10 / ISO 4 and sterile cleanroom programs where a sterile glove with lot traceability supports contamination control expectations.
  • Chemo + chemical barrier story: Designed for workflows where chemotherapy drug testing and chemical resistance are part of the documented risk assessment (confirm against your drug/chemical list).
  • Accelerator-free nitrile: Helps reduce sensitization concerns associated with chemical accelerators, while also avoiding natural rubber latex exposure risk.
  • Donning discipline: Chlorinated internal surface supports smoother donning, useful in double-glove sequences and frequent glove changes.
  • Cleanroom cleanliness metrics: Controlled particle performance supports use in critical zones when technique and change frequency are properly managed.
  • Packaging strategy: Pair-per-wrap with pouch/bag/case configuration supports controlled transfer practices and point-of-use sterility maintenance.
SOSCleanroom selection philosophy
SOSCleanroom supports customers who need dependable, best-in-class cleanroom consumables. In critical environments, we do not recommend “good enough” substitutes when process risk, product integrity, and compliance expectations are on the line.
4. Materials and construction
  • Material: Nitrile
  • Color: Green
  • Shape: Hand specific
  • Cuff: Beaded; cuff length: Standard
  • External surface: Smooth with micro-textured finish
  • Internal surface: Chlorinated
  • Powder content: Powder-free
5. Specifications in context

These specifications matter most when they are tied to how your operators actually work: how gloves are staged, donned, sanitized, and changed. For sterile/critical tasks, the practical goal is to maintain consistent technique and a predictable barrier margin while avoiding self-inflicted contamination events (poor donning, over-sanitization, and uncontrolled touch patterns).

Specification Value Operational meaning
Cleanroom class Class 10 / ISO Class 4 (also positioned for EU GMP Grade A/B use) Appropriate for critical-zone work when paired with validated aseptic technique, controlled transfers, and defined change frequency.
Sterility Sterile; SAL 10-6 Sterile presentation supports aseptic workflows; maintain sterility through proper transfer and point-of-use handling.
Freedom from holes AQL 1.5 A quality benchmark for pinholes; your real-world protection also depends on snag avoidance and timely change-out.
Length 300 mm / 12 in Supports wrist coverage; pair with sleeve interface control (cuff-over-sleeve or taped interface, per SOP).
Thickness targets Palm 0.11 mm; Finger 0.15 mm; Cuff 0.08 mm Balances dexterity with barrier margin; thicker finger area supports pinch/grip tasks common in staging and aseptic handling.
Tensile (before aging) Refer to manufacturer PDS Use to compare mechanical robustness across candidate gloves; focus on real failure points (snags at edges, ports, clamps).
Force at break (before aging) Refer to manufacturer PDS Useful for comparing tear resistance; validate against your fixtures and handling steps.
Tested for chemotherapy drugs Yes Supports hazardous drug program documentation; verify drug list, concentration, and exposure time assumptions.
Anti-static Yes Helps reduce static-related attraction of particulates; still requires facility ESD controls where applicable.
Country of origin Malaysia Useful for supplier qualification records and continuity planning.
Shelf life 5 years from date of manufacture Supports inventory planning; rotate stock and protect from heat/ozone/sunlight per storage guidance.
6. Cleanliness metrics

For ISO 4 sterile work, glove cleanliness is managed as a system: glove cleanliness metrics + operator technique + surface controls. BENS is listed with a typical particle level (≥ 0.5 µm) below; treat this as a comparative metric and validate in your process (especially if your workflow includes frequent alcohol wiping and repeated contact with critical surfaces).

Metric Value Method / reference
Typical particle count ≥ 0.5 µm < 1,200 counts / cm2 Cleanroom glove cleanliness practices commonly reference IEST-RP-CC005 series guidance
Freedom from holes AQL 1.5 Glove integrity testing conventions are addressed in applicable PPE standards; align acceptance criteria to your QA program

Practical note: If your operators sanitize gloves frequently, define a facility-specific approach (agent, contact time, reapplication triggers, and glove change-out triggers) so alcohol use does not become an uncontrolled variable.

7. Packaging, sterility, and traceability
  • Case configuration: 1 pair per inner wrap; 1 inner wrap per pouch; 10 pouches per outer bag; 20 outer bags per lined carton (200 pairs)
  • Sterilization method: Gamma irradiation (minimum dose listed as 25 kGy)
  • Available sizes: 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0
  • Shelf life: 5 years from date of manufacture (store dry, away from direct sunlight and ozone sources, in original packaging)
8. Best-practice use
Customer SOP disclaimer
This guidance is provided as a suggested starting point for customer SOP development and operator training. Every cleanroom and process is different. Customers must evaluate risk, validate procedures, and obtain appropriate QA/ES approval before implementation. Always follow your facility gowning and aseptic technique requirements and the manufacturer’s instructions for use.
  • Stage with intent: Bring only what you will use into the critical zone; keep spare gloves and wipes staged outside the highest-risk area to reduce packaging debris and touch events.
  • Donning without particle events: Use deliberate, low-shear donning. Avoid “snap” motions that generate particles and increase the chance of micro-tears at fingertips.
  • Sanitization (facility-defined): If alcohol wiping of gloved hands is part of your program, standardize contact time, reapplication triggers, and when sanitization requires a glove change.
  • Double-donning: For cytotoxic/chemical workflows, many programs double-glove. Define whether BENS is intended as the inner glove, outer glove, or both — and align to permeation assumptions.
  • Change-out triggers: Define triggers (task-based, time-based, post-contact with non-sterile surfaces, after aggressive wiping, after snag events, or when breakthrough risk timing is reached in HD programs).
Suggested pairings: wipers, swabs, and solutions for sterile glove workflows
In ISO 4 work, glove performance is only part of the outcome. Consistency improves when teams standardize the “glove + wiping + detailing + solution” set so operators are not improvising at point-of-use.
Use case Recommended item Why it pairs well
ISO 4 critical wipe-downs (equipment, benches, transfer items) Texwipe TX3211 SterileWipe™ LP 9" x 9" Sterile Polyester Wiper Sterile presentation with low-lint polyester knit performance for routine critical-zone wipe-downs and solution application.
Sterile gowning room wipe-downs and aseptic support areas Texwipe TX3224 Sterile TexTra™ 10 9" x 9" Sterile Polyester Wiper Higher absorbency knit option for broader wipe-downs where you want controlled solution pickup and removal.
Detail cleaning (ports, fittings, interfaces, corners) Texwipe STX758B Sterile Micro Alpha® Polyester Knit Swab Micro geometry helps reduce “missed soil” risk in tight features; sterile packaging supports point-of-use control.
Sterile IPA delivery (routine spray application) Texwipe TX8270 Sterile 70% IPA (8 oz. Trigger Spray) Point-of-use sterile IPA with adjustable spray delivery for controlled wetting and repeatable technique.
Sterile IPA bulk use (high consumption points) Texwipe TX3290 Sterile 70% IPA (1 Gallon, 4/Case) Best fit for high-volume stations; supports standardized refill and consumption control when permitted by SOP.
Guardrail: Confirm solution compatibility with your surfaces and your facility SOPs (wet-contact time, reapplication triggers, and glove change-out triggers).
9. Common failure modes
  • Over-sanitizing without change discipline: Repeated alcohol wiping can drive handling shortcuts; define when sanitization requires glove replacement.
  • Snags at engineered edges: Ports, clamps, crimps, trays, and sharp cutouts cause fingertip micro-tears — train operators to pause and change after a snag event.
  • Barrier assumptions not matched to exposure time: In hazardous drug programs, permeation data must match the drug, concentration, and task duration actually used.
  • Packaging touch mistakes: Improper transfer of outer packaging into the critical zone creates avoidable touch events and debris risk.
  • Double-glove mismatch: If BENS is used as an underglove, the outer glove choice (material/thickness) still determines the first line of defense and the contamination-contact surface.
10. Other gloves to consider

These alternatives are commonly evaluated in sterile decision sets. Selection should be driven by allergy profile, tactile needs, surface compatibility (sanitization), and the intervention model defined in your facility procedures.

11. Program fit for regulated cleanrooms
  • ISO 4 / Grade A discipline: Supports critical-zone workflows when paired with validated transfer, defined glove change frequency, and documented technique expectations.
  • Hazardous drug alignment: Chemo testing support is helpful where cytotoxic risk assessment and exposure control are formally documented (verify against your HD program design).
  • Allergy risk management: Latex-free and accelerator-free positioning can reduce sensitization concerns in long-duration or high-change-frequency operations.
  • Traceability and investigations: Lot coding and sterile packaging configuration support deviation response and documentation expectations in mature quality systems.
12. Source basis
Product documentation
Standards & guidance references
These references are included to support terminology and program alignment. Customers should confirm applicability to their processes and approved SOPs.
Technical Vault Notice
Important disclaimer: This entry is provided for general process support and reference only. It is not regulatory, legal, medical, or validation advice.
Customers must evaluate risk, confirm applicability to their processes, and follow their approved SOPs, QA requirements, and the manufacturer’s instructions for use.
Questions or documentation requests: Sales@SOSsupply.com  |  (214) 340-8574
Last reviewed: January 30, 2026
© 2026 SOSCleanroom.com