The Technical Vault
By SOSCleanroom
Class 10 / ISO 4
Sterile (SAL 10-6)
Chemo-rated (ASTM D6978)
Accelerator-free
Ansell authorized distributor (3rd-party validated)
Ansell BioClean™ Emerald BENS Sterile Nitrile Gloves — Class 10 / ISO 4, Chemo-Rated Barrier Protection With Sustainability-Minded Packaging
Shown: Emerald-green sterile nitrile glove presentation for critical handling.
1) Practical solutions in a critical environment
When the risk profile includes both contamination control and chemical/cytotoxic exposure, glove selection stops being “PPE procurement” and becomes part of your contamination control strategy. BioClean™ Emerald BENS is positioned for sterile cleanrooms (Class 10 / ISO 4) where teams need a sterile presentation, low particle contribution, and a defensible barrier story for chemicals and chemotherapy drugs—without introducing accelerator-related sensitization risks.
Operationally, Emerald BENS is commonly used as an underglove for double-donning workflows, where the inner glove must be easy to don, predictable in fit, and clean processed to support viable and non-viable contamination controls.
2) What it’s for
- Sterile handling in Class 10 / ISO 4 cleanrooms and other sterile controlled environments
- Aseptic processing and sterile transfer tasks where glove sterility assurance and documentation matter
- Hazardous drug and cytotoxic handling programs where chemo permeation data is required for risk assessment
- Double-gloving practices (as an underglove) to reduce change frequency and strengthen barrier margin
- Skilled, dexterity-heavy work: sampling, transfers, aseptic filling/labeling, and sterile processing tasks
3) Why should customers consider these gloves
- Sterile assurance with audit-friendly language: gamma sterilized with SAL 10-6 and published sterilization method details.
- Chemo-rated barrier positioning: tested for chemotherapy drugs (ASTM D6978) and supported with a chemotherapy permeation summary for risk-based selection.
- Accelerator-free, powder-free, latex-free: reduced risk of Type I latex allergy and Type IV chemical sensitivities in glove-heavy operations.
- Clean processed for critical zones: deionized washing is used to reduce surface particulates, ionic extractables, and non-volatile residues (process intent stated by manufacturer).
- Sustainability-minded packaging concept: recyclable plastic packaging and recycled cardboard shipper cases are emphasized by the manufacturer; inner components are polyethylene (PE) film (local recycling rules vary).
- Fit and function for double-donning: hand-specific shaping and micro-textured finish support grip without aggressive surface texture that can increase snag risk on delicate packaging or components.
4) Materials and construction
Emerald BENS is a sterile, single-use nitrile glove with a beaded cuff and a smooth external surface with a micro-textured finish. The internal surface is chlorinated to support donning control (especially relevant for sterile inner-glove workflows). The glove is described as anti-static by the manufacturer and is presented as hand-specific (right/left) to support ergonomic fit and reduce fatigue during long-duration tasks.
Manufacturer-stated country of origin: Malaysia. This matters for some quality systems and supplier qualification packages; document it in your approved supplier file if your program tracks COO as part of change control.
5) Specifications in context
In ISO 4 / Class 10 environments, gloves are often the highest-frequency human-to-product interface. Small spec differences (length, thickness, AQL, particle contribution, sterilization method) show up as real operational outcomes: doffing frequency, tear rates, grip quality under IPA, and how often you need to re-gown after a glove change. Emerald BENS is built around “repeatable inner-glove behavior” for double-gloving: 12-inch length for gown interface control, published thickness targets for tactile performance, and a sterile presentation aligned to aseptic workflows.
| Specification |
Value (manufacturer-published) |
| Cleanroom classification |
Class 10 / ISO Class 4; described as applicable to EU GMP Grade A/B and other sterile cleanrooms |
| Sterility assurance |
Gamma sterilized; SAL 10-6; minimum dose 25 kGy |
| Length |
300 mm / 12 in |
| 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) |
| Freedom from holes |
1.5 AQL (Inspection Level I) performance |
| Composition / allergy profile |
Nitrile; powder-free; latex-free; accelerator-free |
| Finish and fit |
Hand specific; smooth with micro-textured finish; beaded cuff; internal chlorination |
| Antistatic |
Yes (manufacturer stated) |
| Shelf life |
Five (5) years from date of manufacture (when stored as directed) |
| Chemo drug testing |
Tested for use with chemotherapy drugs (ASTM D6978) |
6) Cleanliness metrics
In ISO 4 zones, cleanliness data is typically used two ways: (1) initial qualification/selection and (2) investigation support (when particulate or residue excursions occur). Below are manufacturer-published cleanliness indicators for Emerald BENS. If your CCS (contamination control strategy) requires additional metrics (endotoxin, NVR, sterility certificate format), request the specific lot documentation package before final approval.
| Metric |
Typical / stated value |
Test context |
| Typical particle count |
< 1200 counts/cm2 (≥ 0.5 µm) |
IEST-RP-CC005.4 (as cited by manufacturer) |
| Ionic extractables (examples) |
Chloride < 0.35; Sodium < 0.05; Sulphate < 0.05; Calcium < 0.60; Potassium < 0.08 (units stated by manufacturer as concentration in µg/cm)
|
Manufacturer-published ionic content table (typical values) |
| Non-volatile residue (NVR) |
Not published as a numeric value in the glove PDS (manufacturer states deionized washing reduces NVR) |
Documented as process intent; request additional data if your CCS requires a limit |
7) Packaging, sterility, and traceability
Emerald BENS is packaged to support aseptic donning discipline and controlled introduction. Packaging configuration (manufacturer stated):
- 1 pair per inner wrap
- 1 inner wrap per pouch
- 10 pouches per outer bag
- 20 outer bags per lined carton (200 pairs per case)
Sustainability note (manufacturer stated): inner wrap, pouch, bag, and liner are polyethylene (PE) film; shipped in recycled cardboard cases; local recycling acceptability for PE varies by location.
Sterility method and assurance: gamma irradiation with SAL 10-6 and a stated minimum sterilization dose of 25 kGy. In regulated programs, retain the applicable declaration/certificates in your qualification packet and align them to your CCS traceability expectations (lot tracking, deviation handling, and incoming inspection).
8) Best-practice use
Customer SOP disclaimer (read before adopting technique guidance)
The guidance below is a practical starting point for technician training and contamination-control consistency. It is not a facility SOP. Your organization is responsible for final SOPs, validation/qualification, regulatory alignment (FDA/USP/ISO as applicable), and documenting safe-use decisions for chemicals and hazardous drugs.
Aseptic donning and double-gloving discipline (typical ISO 4 practice): Use Emerald BENS as the underglove when the outer glove is changed frequently due to contact risk, disinfectant exposure, or task transitions. The underglove should remain protected during spray/wipe disinfection of the outer glove. If your workflow requires frequent outer-glove changes, choose an underglove that maintains tactile control and minimizes fatigue—this is where hand-specific shaping and published thickness targets matter.
- Glove change triggers: torn glove; visible residue; contact with non-controlled surfaces; extended exposure to aggressive chemistries; after handling cytotoxic drugs per your hazardous drug work practice.
- Alcohol compatibility reality: frequent IPA wipe-down can dry glove surfaces and change grip behavior. Train operators to use controlled wetness (enough to wet, not enough to drip) and to re-wet only as needed for contact time expectations.
- Cuff control: ensure the beaded cuff stays captured under the gown interface to reduce skin exposure and to keep the “clean boundary” stable during arm movement.
- Chemo handling: permeation data supports selection, but it does not equal safe wear time. Align glove change frequency to your internal risk assessment, drug set, and exposure scenario.
Pairing guidance for ISO 4 work (glove + wipe + swab): In real ISO 4 operations, glove selection is only half the control—your wipe/swatch tools often drive residue and particle outcomes.
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. For an ISO 4-aligned wipe tool, consider Texwipe Vectra® Alpha® Nu TX1069, which is described by Texwipe as ideal for ISO Class 1–4 areas and is engineered as a low-linting sealed-border polyester knit wiper.
For precision cleaning where a wiper cannot reach (ports, joints, recesses), qualify a cleanroom-processed foam swab geometry such as the Texwipe CleanFoam® Series (example: TX742B) based on your surface, solvent, and residue risk.
9) Common failure modes
- Unexpected tears during double-donning: usually driven by donning speed, sharp nail edges, jewelry policy violations, or friction from overdrying hands. Correct with donning technique, sizing, and hand prep controls.
- Grip variability after repeated disinfection: excessive IPA exposure can change tactile feel. Train “wipe once, inspect, re-wet only if needed,” and avoid over-spraying.
- False confidence from permeation tables: permeation breakthrough times are lab-based. Build your change frequency and exposure controls around your actual process (drug set, concentration, temperature, contact type).
- Packaging handling contamination: the most sterile glove can be compromised by poor pouch opening technique. Train controlled tearing/opening and “no reach-back” habits, and validate glove presentation at the point of use.
- Wrong size selection: too small increases tear risk; too large reduces dexterity and can increase touch contamination. Use a standardized sizing check during onboarding.
10) Closest competitors
In Class 10 / ISO 4 sterile nitrile programs, “closest competitors” are typically defined by sterility presentation, published cleanliness/particle performance, and available documentation for qualification packages (AQL, sterility assurance, and chemical/chemo positioning).
- Ansell BioClean™ Excell BEXS (sterile nitrile, ISO 4): often selected when teams want to stay within the BioClean documentation ecosystem but tune feel/fit and surface behavior for specific tasks.
- Ansell BioClean™ Nerva BNAL (cleanroom nitrile, ISO 4): used when extended protection profile or task-specific geometry is required (program-dependent).
- Kimtech™ G3 Sterile Sterling™ nitrile: a commonly qualified sterile nitrile option in sterile cleanrooms with published SAL and particle cleanliness positioning; often evaluated head-to-head on donning behavior and grip under IPA.
Practical selection note: if you are building a double-glove system, evaluate underglove + overglove as a pair. The “best” underglove is the one operators can don consistently, that stays intact under repetitive glove sanitization, and that supports the required change frequency without fatigue-driven errors.
11) Program fit
Ansell and BioClean in cleanroom programs: Ansell positions its cleanroom portfolio around contamination-control discipline (sterile-ready packaging, documented performance, and certification structures). In hazardous drug and cytotoxic workflows, that matters because glove choice must integrate PPE protection, aseptic technique, and documentation readiness into one auditable story.
SOSCleanroom supply reliability signal: Cleanroom Technology reported that SOS Cleanroom Supply became an Ansell authorized distributor (published June 20, 2023). That third-party validation supports the program expectation many regulated teams have: stable sourcing, dependable documentation routing, and continuity of supply.
US standards first, global benchmark second: US programs typically anchor to FDA expectations (aseptic processing guidance where applicable) and USP chapters relevant to the work (for example, USP <797> and USP <800> in compounding and hazardous drug handling contexts), with ISO 14644 terminology for cleanroom classification. EU GMP Annex 1 is often used as a secondary benchmark to sharpen CCS thinking (risk-based contamination control, transfer discipline, and documentation rigor) without implying it is a US legal requirement.
Completing the “hand + surface” control loop (ISO 4): If Emerald BENS is your inner-glove standard, align the rest of the consumables to the same zone risk. 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. For ISO 4 wipe-downs, Texwipe Vectra® Alpha® Nu TX1069 is described as suitable for ISO Class 1–4 areas and is designed as a low-linting, sealed-border polyester wiper. For tight geometries and controlled application/removal of solvents, qualify a compatible cleanroom foam swab geometry (example: Texwipe CleanFoam® Series TX742B) based on your CCS residue and particle risk.
12) Source basis
Primary product pages and manufacturer documentation
SOSCleanroom product page (BENS):
https://www.soscleanroom.com/product/brands/ansell-bens-bioclean-emerald-sterile-nitrile-gloves-class-10-iso-4/
Ansell product page (BioClean Emerald BENS):
https://www.ansell.com/us/en/products/bioclean-emerald-bens
Manufacturer Product Data Sheet (PDS) — “Emerald BENS Sterile Disposable Nitrile Cleanroom Glove” (© 2022 Ansell Limited):
https://www.soscleanroom.com/content/Ansell_PDF/bioclean-emerald-bens_pds_us.pdf
EU Declaration of Conformity (BENS) — SOS-hosted PDF:
https://www.soscleanroom.com/content/Ansell_PDF/bioclean-emerald-bens_bioclean%E2%84%A2-emerald%20bens_eu_20230511_declaration%20of%20conformity.pdf
Chemical Permeation Report Summary (EN 16523-1:2015) — SOS-hosted PDF:
https://www.soscleanroom.com/content/Ansell_PDF/Chemical%20Permeation%20Report%20Summary_BENS.pdf
Chemotherapy Permeation Report (ASTM D6978) — SOS-hosted PDF:
https://www.soscleanroom.com/content/Ansell_PDF/TSK-22437%20-%20Chemotheraphy%20Permeation%20Brochure%20-%20BENS-HR.pdf
Third-party validation (Ansell + SOSCleanroom relationship)
Cleanroom Technology (June 20, 2023):
https://www.cleanroomtechnology.com/sos-cleanroom-supply-becomes-ansell-authorised-distributor-209576
Complementary contamination-control tools (ISO 4-aligned examples)
Texwipe Vectra® Alpha® Nu TX1069 datasheet (ISO Class 1–4; Made in USA) — SOS-hosted PDF (DS-1069, Effective: Dec. 2009):
https://www.soscleanroom.com/content/texwipe_pdf/1069.pdf
Texwipe CleanFoam® Swabs Series B TDS (includes TX742B contamination characteristics) — SOS-hosted PDF:
https://www.soscleanroom.com/content/texwipe_pdf/740b%20741b%20742b%20751b%20752b%20757b.pdf
Texwipe TX742B product page (technical downloads and specs):
https://www.texwipe.com/small-cleanfoam-tx742b
Standards and regulatory bodies (education and terminology)
ISO (ISO 14644-1 landing page provided):
https://www.iso.org/standard/53394.html
FDA (general regulatory reference):
https://www.fda.gov
ASTM (test method standards reference):
https://www.astm.org
IEST (recommended practices and contamination-control guidance):
https://www.iest.org
SOSCleanroom is the source for this Technical Vault entry.
Briefed and approved by the SOSCleanroom (SOS) staff.
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Last reviewed: Jan. 10, 2026
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