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Ansell BNAL BioClean Nerva Cleanroom Nitrile Gloves Class 10 (ISO 4)

Ansell BNAL BioClean Nerva Cleanroom Nitrile Gloves Class 10 (ISO 4)

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SKU:
BNAL
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1000 Gloves
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Ansell BioClean™ Nerva BNAL Cleanroom Nitrile Gloves (White) — Class 10 (ISO 4) Elbow-Length, Accelerator-Free Chemical Splash Protection
Nitrile Class 10 / ISO 4 400 mm / 16" elbow length Accelerator-free Textured fingers + palm PPE Category III (EU) Non-sterile
 
What this glove is built to do in ISO 4 work
BioClean™ Nerva BNAL is an elbow-length (400 mm / 16") nitrile cleanroom glove designed for Class 10 (ISO 4) environments where hand and forearm coverage, chemical splash resistance, and contamination control must work together. The extended cuff helps reduce cross-contamination risk at the gown/glove interface, the textured palm and fingers improve handling confidence in wet or dry conditions, and the beaded cuff supports more stable donning and less roll-down during long tasks.
This glove is non-sterile and is commonly selected when sterile presentation is not required or when a risk-based approach calls for double-gloving with BNAL as the outer glove to protect the inner glove from chemical exposure or high-contact abrasion.
Critical note for regulated pharmacy and aseptic programs
In U.S. operations, glove selection is typically justified within a contamination control strategy aligned to FDA cGMP expectations and site SOPs (and, where applicable, USP <797>/<800>). EU GMP Annex 1 can be used as a secondary benchmark for continuous improvement and risk-based CCS discipline. This glove supports the coverage and handling side of control; it does not replace validated gowning, disinfecting, and gloving-change practices.
Why SOSCleanroom recommends Ansell for critical gloves
Ansell is SOSCleanroom’s best-in-class glove line for cleanrooms and laboratories. In critical environments, SOS does not compromise on glove quality because the glove is part of your contamination control system: it touches product-contact surfaces, tools, equipment interfaces, door hardware, carts, and critical components where a single failure can become a deviation, rework event, or customer complaint. BioClean™ gloves are engineered for controlled environments with published cleanliness context, defined thickness targets, and documentation that helps quality teams standardize and defend a program.
Key performance and contamination-control drivers
  • Elbow-length coverage (16"): More forearm protection to reduce cross-contamination risk near sleeves and gown cuffs during wipe-downs, transfer, and wet work.
  • Accelerator-free, latex-free, powder-free: Reduced risk of Type I latex allergy concerns and reduced powder-related contamination pathways (operator and process dependent).
  • Textured fingers and palm: Improved grip in wet handling (IPA, disinfectants, buffer solutions) and during glove-on-glove interactions in double-gloving workflows.
  • Beaded cuff + chlorinated interior: Donning stability with a smoother internal surface to support consistent glove changes and less “hang-up” on damp hands.
  • Published cleanliness context: Typical particle count and typical ionic extractables help teams plan risk and validate incoming materials where background matters.
  • Double-gloving intent: Recommended as an outer glove when an added protection layer is needed (site risk assessment and SOP required).
Specifications (published values)
Cleanroom class Class 10 / ISO 4
Material / color Nitrile / White
Sterility Non-sterile
Length 400 mm / 16" (typical)
External surface Textured fingers and palm
Internal surface Chlorinated
Cuff Beaded; extended
Freedom from holes (AQL) 0.65 AQL (Performance Level 3)
Thickness (single-wall targets) Finger: 0.16 mm (6.30 mil)  |  Palm: 0.10 mm (3.94 mil)  |  Cuff: 0.08 mm (3.15 mil)
Typical particle count < 2800 counts/cm² at ≥ 0.5 µm (per IEST-RP-CC005.4 test method reference)
Shelf life / storage 5 years from date of manufacture. Store in a dry, cool place (<40°C) away from direct sunlight and fluorescent light.
Country of origin (published) Malaysia
Size note: The published product data sheet lists S–XXL sizing. The SOSCleanroom product configurator may display additional sizes based on current availability and ordering configuration.
Typical ionic extractables (published values)
For ISO 4 programs, ionic background can matter when you are handling optics, sensitive coatings, residue-sensitive assemblies, or performing analytical work where blanks/background must stay stable. Below are the published typical ionic values (units shown as µg/cm²).
Ion Typical concentration (µg/cm²) Ion Typical concentration (µg/cm²)
Ammonium 0.020 Nitrate 0.500
Calcium 0.400 Phosphate 0.060
Chloride 0.030 Potassium 0.060
Fluoride Not detected Sodium 0.050
Magnesium Not detected Sulphate 0.100
Bromide Not tested Nitrite Not tested
Lithium Not tested Zinc Not detected
Values are typical published concentrations and should be used as planning context (not as specification limits). Use your site’s qualification/validation approach for acceptance criteria.
Chemical permeation snapshot (selected agents)
For cleaning and disinfection operations, chemical compatibility cannot be assumed. The BNAL permeation summary reports mean breakthrough times (minutes) using standardized methods (including ASTM F739). Treat these values as a starting point for your risk assessment and always validate against your chemical concentration, temperature, exposure duration, and task mechanics.
Chemical agent (concentration) Mean breakthrough time (minutes)
Ammonium hydroxide (28%) 26
Citric acid (10%) >480
Glutaraldehyde (50%) >480
Hexane 33
Hydrochloric acid (32%) 397
Hydrochloric acid (37%) 135
Hydrogen peroxide (30%) >480
Iodine (10%) >480
Isopropanol (70%) 31
n-Heptane 51
Phosphoric acid (85%) >480
Sodium hydroxide (40%) >480
Sodium hypochlorite (12%) >480
Sulfuric acid (96%) 11
Always confirm chemical compatibility for your exact formulation and dwell/exposure profile. If your operation is tied to hazardous drugs (USP <800>), note that BNAL is published as not tested for use with chemotherapy drugs.
How to use BNAL well (operator-level discipline)
  • Donning: Use a controlled donning method that avoids touching non-controlled surfaces. Seat the beaded cuff fully to reduce roll-down and sleeve gaps.
  • Glove changes: Change gloves after chemical exposure, visible soil, puncture risk events, or task transitions (clean-to-dirty boundaries). A consistent change cadence is often more effective than “as needed.”
  • Double-gloving: If your CCS/SOP calls for layered protection, use BNAL as the outer glove and treat outer-glove removal as a contamination control step (slow peel, no snap, controlled disposal).
  • Wet work: When handling disinfectants or alcohol, keep technique consistent. Excess liquid increases runoff and sleeve wetting; under-wetting can compromise dwell/contact time for disinfectants.
  • Storage: Keep cartons sealed until use and store below 40°C away from direct light to preserve material performance and reduce aging risk.
When you should step up to sterile gloves
BNAL is non-sterile. If your process requires sterile presentation for aseptic manipulations, sterile field proximity, or documented sterile introductions, select a sterile cleanroom glove that matches your ISO-class risk profile and SOP. SOSCleanroom can help align glove choice to your zone classification and validation expectations.
Matched Texwipe consumables for ISO 4 environments (recommended complements)
When you are operating at ISO 4, gloves and wiping systems should be matched to the same contamination-control tier. 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. Below are ISO 4-appropriate Texwipe options customers often pair with BNAL for documented wipe-downs and controlled transfer steps.
  • Texwipe TX3224 Sterile TexTra™ 10 (9" x 9") dry wipers: sealed-border polyester knit, sterile (SAL 10-6) for aseptic wipe-down workflows where edge control and documentation matter.
  • Texwipe STX1704P Sterile Revolve™ (4" x 4") pre-wetted 70% IPA: sterile, sealed-edge, small-format control for hoods, isolators, pass-throughs, and tight equipment interfaces. Low-linting performance; no wiper is truly “lint-free” in every process condition.
  • Texwipe TX3042P Sterile Vertex® (12" x 12") pre-wetted 70% IPA: larger-format sterile, sealed-edge knit for repeatable wipe-down steps that benefit from standardized wetness (vs. spray-and-wipe variability).
If you have any questions please email us at Sales@SOSsupply.com or give us a call at (214)340-8574.
OR check out the AI ChatBot powered by SOSCleanroom data libraries - give it a try! THIS IS NEW FOR 2026!
Last updated: Jan. 10, 2026  |  © 2026 SOSCleanroom.com. All rights reserved.
The Technical Vault
By SOSCleanroom
BNAL Nitrile Class 10 / ISO 4 Non-sterile 16-inch / 400 mm PPE Category III
Ansell BioClean™ Nerva BNAL (ISO 4 / Class 10) Nitrile Cleanroom Gloves — Elbow-Length Chemical-Resistance PPE for Controlled Environments
A glove is never “just PPE” in an ISO 4 space. It is a moving surface that touches tools, containers, fixtures, and high-risk interfaces all day long. BNAL is designed for controlled environments where the operator needs extended forearm coverage (400 mm / 16-inch), confident grip, and standards-backed chemical-permeation performance without introducing unnecessary contamination variables.
Ansell BioClean Nerva BNAL nitrile cleanroom gloves (ISO 4 / Class 10)
BioClean Nerva BNAL: extra-length nitrile cleanroom gloves for ISO 4 / Class 10 work zones.
Practical solutions in a critical environment
BNAL earns its place when your contamination-control strategy (CCS) depends on disciplined technique: fewer exposed forearm surfaces, fewer cuff roll-down events, and fewer “wet cuff” transfers when operators handle solutions, small containers, and wipe-wet surfaces. In regulated or audit-heavy operations, the value is repeatability: a known glove model with published physical properties, published cleanliness indicators, and documented chemical-permeation testing that can be referenced during risk reviews and change-control.
What is this glove used for
  • ISO 4 / Class 10 cleanrooms where extended coverage helps reduce forearm skin exposure and cuff-interface contamination.
  • Handling and transfer of wet items (wipe-wet tools, solution bottles, fixtures) where beaded cuffs and added length help reduce drip paths and roll-off.
  • Lab and R&D / production tasks where chemical-contact risk exists and ASTM/EN permeation data is needed for selection documentation (always validate to your chemical, exposure time, and task specifics).
  • Double-gloving programs where BNAL is specified as the outer glove (per manufacturer guidance).
Why should customers consider this glove
  • Elbow-length coverage (400 mm / 16-inch): reduces exposed forearm surface and supports cleaner gown-to-glove interfaces in ISO 4 zones.
  • PPE Category III chemical-risk posture: supported by declared conformity and referenced EN chemical standards for higher-risk chemical tasks.
  • Defined quality indicator (AQL 0.65): supports lot acceptance logic and procurement consistency for holes/defects control.
  • Textured fingers and palm: improves grip under wipe-wet handling without relying on excessive pinch force (a common tear driver).
  • Non-particulating EasyTear packaging concept: supports cleaner opening behavior and reduced handling disruption at the point of use.
Materials and construction
BNAL is a powder-free, latex-free, non-sterile nitrile glove with a chlorinated internal surface (helps donning) and textured external surface on fingers and palm (helps wet grip). The beaded cuff supports cuff integrity and helps reduce cuff roll when sleeves or gown cuffs apply shear forces.
Attribute Published value
Material Nitrile
Color White
Shape Ambidextrous
Cuff Beaded; extended (16-inch / 400 mm)
Internal surface Chlorinated
External surface Textured fingers and palm
Cleanroom class Class 10 / ISO 4
Sterile No
Specifications in context
BNAL is often selected when the task risk is at the cuff and forearm interface, not just at the fingertips. In ISO 4 work, operators commonly create contamination pathways through sleeve creep, cuff roll, or wet cuffs contacting benches and carts. The extended 16-inch length helps reduce those “edge conditions,” especially when paired with gowning discipline and a defined glove-change cadence.
Spec Published value Why it matters in ISO 4 work
Freedom from holes 0.65 AQL (Inspection Level I), Performance Level 3 Supports defect-control expectations and helps reduce “mystery leaks” during wet handling.
Target thickness (palm) 0.10 mm (3.94 mil) Balances tactile feedback with barrier needs for many common cleaning/transfer tasks.
Target thickness (finger) 0.16 mm (6.30 mil) Helps reduce fingertip failure during pinch-heavy tasks and repeated tool handling.
Target thickness (cuff) 0.08 mm (3.15 mil) Cuff integrity and roll resistance matter when sleeves and tape interfaces add friction.
Double-gloving recommendation Yes, as outer glove Supports contamination control and task segmentation (outer glove changes more frequently).
Tested for chemotherapy drugs No For USP <800> hazardous drug programs, align glove selection to HD-specific requirements and your facility risk assessment.
Chemical permeation snapshot (continuous-contact testing): The summary below is useful for screening, but it does not replace your CCS, SDS review, task exposure time, splash vs. immersion assumptions, or your safety team’s selection process.
Chemical agent (test concentration) Mean breakthrough time (minutes) Notes for cleanroom users
Isopropanol (70%) 31 Useful for IPA-contact tasks, but do not treat this as “all-day” exposure; define glove-change triggers for wet handling.
Hydrogen peroxide (30%) >480 Good screening indicator for peroxide exposure; always confirm task specifics (concentration, time, temperature).
Sodium hypochlorite (12%) >480 Relevant for bleach-contact cleaning/disinfection workflows; validate against your actual formulation and contact pattern.
Glutaraldehyde (50%) >480 Strong indicator for high-resistance in the test method; ensure your EH&S controls align with the chemical hazard profile.
Sulfuric acid (96%) 11 Short breakthrough time: treat as a high-risk exposure scenario; review dedicated acid PPE requirements.
Cleanliness metrics
In ISO 4 work, “clean” must be operational: measurable background indicators that help you define limits, evaluate changes, and avoid silent process drift. Use the metrics below as planning inputs and tie them to your internal acceptance criteria and monitoring strategy.
Typical particle count (glove surface):
Metric Published value Test reference
Particles ≥ 0.5 µm (counts/cm²) < 2800 IEST-RP-CC005.4
Typical ionic content (surface extractables):
Ion Typical concentration (µg/cm²) Notes
Ammonium 0.020 Planning indicator for sensitive residue/ionic background work.
Calcium 0.400 Often tracked in precision cleaning and some analytical workflows.
Chloride 0.030 Relevant to corrosion-sensitive surfaces and ionic contamination controls.
Nitrate 0.500 Highest listed typical anion in the published set; confirm suitability to your limits.
Phosphate 0.060 Relevant to residue-sensitive processes and some analytical methods.
Potassium 0.060 Useful planning indicator for ionic-background management.
Sodium 0.050 Common contaminant of interest; tie to your acceptance criteria.
Sulphate 0.100 Corrosion and residue relevance depends on materials and processes.
Fluoride Not detected Published as not detected in the typical data set.
Magnesium Not detected Published as not detected in the typical data set.
Zinc Not detected Published as not detected in the typical data set.
Packaging, sterility, traceability
  • Pack configuration: 100 pieces per sealed inner PE bag; one inner bag per sealed outer PE bag; 10 outer bags per lined carton (1,000 gloves per case).
  • Sterility: non-sterile. If sterility is required for your ISO 4 workflow, select a sterile glove model validated to your facility’s sterility assurance requirements.
  • Storage: store in a dry, cool place (< 40°C) away from direct sunlight and fluorescent light.
  • Shelf life: five (5) years from date of manufacture (published).
  • Country of origin (published): Malaysia.
Best-practice use
ISO 4 performance is usually won or lost by technique. The glove can be excellent on paper and still fail in practice if operators treat it like a generic disposable.
  • Glove-change discipline: define triggers (tear, wet cuff, visible soil, leaving/entering critical zone, after chemical handling steps) instead of changing “when it feels dirty.”
  • Double-gloving: if your program uses two gloves, treat the outer glove as consumable and change it frequently. BNAL is recommended as an outer glove.
  • Grip without over-force: textured palms help; train operators to avoid excessive pinch force on thin components (pinch force is a leading contributor to fingertip tears).
  • Wet work controls: if sleeves or gown cuffs become wet, treat it as a contamination event and follow your CCS response (change glove, evaluate gown interface, and sanitize per SOP).
  • Chemical selection logic: use permeation data as screening and document the decision. Confirm actual task conditions (concentration, temperature, contact time, splash vs. immersion) and align with EH&S requirements.
  • Pharmacy compounding note: BNAL is not tested for chemotherapy drugs. Where USP <800> applies, select HD-appropriate gloves per your hazardous drug risk assessment.
U.S. standards first, global benchmark second: Many U.S. customers align glove programs to FDA cGMP/aseptic processing expectations and ISO 14644 cleanroom classification terminology, and then use EU GMP Annex 1 as a secondary benchmark to strengthen contamination-control strategy thinking (CCS, risk-based controls, and disciplined personnel practices). Use Annex 1 for continuous improvement — not as a statement of U.S. legal requirement.
Common failure modes
  • Cuff roll and sleeve creep: usually a training and interface problem. Standardize gown-to-glove sequence and tape/interface rules (if used) to prevent wet cuff transfer.
  • Pinch-tear at fingertips: driven by force, sharp edges, and repetitive manipulation. Train for tool-assisted handling where possible and replace gloves before a micro-tear becomes a contamination event.
  • False confidence in chemical resistance: permeation charts are not “permission slips.” Define conservative exposure assumptions and set glove-change cadence for chemical-contact tasks.
  • Wrong glove for sterility requirement: BNAL is non-sterile. If you require sterile glove presentation (or sterile validated processing), select a sterile BioClean option and align it to your aseptic practice and documentation.
Closest competitors
Selection should be driven by sterility need, cuff length, extractables background expectations, and chemical-contact risk.
  • Ansell Nitrilite 93-401 (Class 10 / ISO 4): a non-sterile cleanroom nitrile option positioned for very low ionic content (useful where ionic background is the dominant concern).
  • Ansell BioClean Excell (BEXS) sterile nitrile (ISO 4 / Class 10): consider when sterility is required in the work zone (validate presentation and sterility requirements to your SOP).
  • Ansell BioClean Emerald (BENS) sterile nitrile (ISO 4 / Class 10): another sterile pathway for ISO 4 environments when sterile glove controls are mandatory.
Program fit
SOSCleanroom positions Ansell as a best-in-class glove line for critical environments. In ISO 4 operations, “saving cost on gloves” is rarely a true savings once you account for defect risk, rework, investigation time, and change-control burden.
Distributor trust line (third-party validation): Cleanroom Technology reported that SOS Cleanroom Supply became an Ansell authorised distributor, reinforcing supply-chain credibility for customers who require documented sourcing and continuity.
ISO 4 companion consumables (ITW Texwipe): In ISO 4 spaces, gloves and cleaning materials must work together. 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. If you want to keep the glove/wipe/cleaning system aligned to the same environment class, these pair well with BNAL in ISO 4 programs:
  • Texwipe TX1034 AlphaSat 4" x 4" pre-wetted 70% IPA wipers: SOSCleanroom lists ISO 4 (Class 10) among the stated use environments; good for small-area wipe-downs and controlled IPA application where repeatable wetness reduces “operator variability.”
  • Texwipe TX3049 Sterile Vertex® 9" x 9" sealed-edge wipers: designed for ISO Class 3–7 environments with sealed edges to reduce particle release from the edge; useful when your ISO 4 cleaning strategy depends on sterile, sealed-edge wiping and strong sorption for spill control.
Selection checkpoint: Always confirm that the glove model (sterile vs. non-sterile), the wiper model (sterile vs. non-sterile, sealed edge vs. cut edge), and the cleaning chemistry (validated concentration, filtration, and contact time) match your room classification, process risk, and documentation requirements. This is where CCS alignment prevents audit pain later.
SOSCleanroom note about SOP's
The Technical Vault is written to help customers make informed contamination-control decisions and improve day-to-day handling technique. It is not your facility’s Standard Operating Procedure (SOP), batch record, or validation protocol.

Customers are responsible for establishing, training, and enforcing SOPs that fit their specific risks, products, equipment, cleanroom classification, and regulatory obligations. Always confirm material compatibility, cleanliness suitability, sterility requirements, and acceptance criteria using your internal quality system and documented methods.

If you adapt any technique guidance from this entry, treat it as a starting template. Your team should review and approve the final method, then qualify it for your specific tasks, chemicals, cleanliness limits, inspection methods, and risk profile. In short: use these best-practice suggestions to strengthen your SOPs—not to replace them.
Source basis
SKU-specific pages and PDFs
  • SOSCleanroom product page (BNAL): https://www.soscleanroom.com/product/brands/ansell-bnal-bioclean-nerva-cleanroom-nitrile-gloves-class-10-iso-4/
  • SOS-hosted Product Data Sheet (BioClean Nerva BNAL, Technical Data Sheet): https://www.soscleanroom.com/content/Ansell_PDF/bioclean-nerva-bnal_pds_us.pdf
  • SOS-hosted EU Declaration of Conformity (BioClean Nerva BNAL): https://www.soscleanroom.com/content/Ansell_PDF/bioclean-nerva-bnal_bioclean%E2%84%A2-nerva%20bnal_eu_20230511_declaration%20of%20conformity.pdf
  • SOS-hosted Chemical Permeation Report Summary (BNAL): https://www.soscleanroom.com/content/Ansell_PDF/Chemical%20Permeation%20Report%20Summary_BNAL.pdf
Third-party validation (Ansell authorised distributor)
  • Cleanroom Technology (Published June 20, 2023): https://cleanroomtechnology.com/sos-cleanroom-supply-becomes-ansell-authorised-distributor-209576
ISO 4 companion consumables (Texwipe)
  • SOSCleanroom product page (Texwipe TX1034): https://www.soscleanroom.com/product/wipers/texwipe-tx1034-alphasat-4-x-4-polyester-cleanroom-wiper-pre-wetted-70-ipa/
  • Manufacturer product page (Texwipe TX3049): https://www.texwipe.com/sterile-vertex-high-sorption-tx3049
  • SOS-hosted PDF (Vertex sterile high-sorption wipers TX3042/TX3049 series): https://www.soscleanroom.com/content/texwipe_pdf/3042%203049%203042p%203049p.pdf
Standards and regulatory bodies referenced for context
  • International Organization for Standardization (ISO) cleanroom classification context (ISO 14644-1): https://www.iso.org/standard/53394.html
  • FDA (Food and Drug Administration) — cGMP / aseptic processing guidance hub: https://www.fda.gov/
  • ASTM (American Society for Testing and Materials): https://www.astm.org/
  • IEST (Institute of Environmental Sciences and Technology): https://www.iest.org/
  • EU GMP Annex 1 (Manufacture of Sterile Medicinal Products) — European Commission PDF: https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf
  • USP (U.S. Pharmacopeia) compounding standards context (USP organization): https://www.usp.org/
  • USP <800> hazardous drugs handling overview: https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare
SOSCleanroom is the source for this Technical Vault entry.
Briefed and approved by the SOSCleanroom (SOS) staff.
If you have any questions please email us at Sales@SOSsupply.com or give us a call at (214)340-8574.
OR check out the AI ChatBot powered by SOSCleanroom data libraries - give it a try! THIS IS NEW FOR 2026!
Last reviewed: January 10, 2026
© 2026 SOSCleanroom