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Ansell BASL BioClean Advance Sterile Latex Gloves Class 10 (ISO 4)

Ansell BASL BioClean Advance Sterile Latex Gloves Class 10 (ISO 4)

$622.90
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SKU:
BASL
Availability:
7 - 10 Business Days
Shipping:
Calculated at Checkout
Quantity Option (Case):
200 Pairs
Inner Packaging:
See Below
Ansell BioClean™ Advance BASL Sterile Latex Gloves — Class 10 / ISO 4 EasyTear® Packaging, Double-Donning Support and High-Grip Textured Fingers
Class 10 / ISO 4 Sterile (SAL 10-6) Natural rubber latex Powder-free Textured fingers EasyTear® low-particulating packaging 11.6" length 200 pairs / case
Product overview
BioClean™ Advance BASL sterile latex cleanroom gloves are designed for Class 10 / ISO 4 operations where operator touch is a primary contamination-control and product-contact risk. BASL is built to support double-donning as an outer glove layer, with textured fingers for confident grip and a beaded cuff for donning stability. Sterilization is by gamma irradiation and the gloves are supplied in non-particulating EasyTear® packaging to reduce particulate generation during transfer, opening and gowning.
Latex note: Natural rubber latex may cause allergic reactions in some individuals. Confirm your site allergen policy and glove material requirements before standardizing.
Why customers choose BASL
  • Class 10 / ISO 4 positioning for critical clean operations where glove shed, transfer discipline and change frequency are central to contamination control.
  • Double-donning-friendly as an outer glove: supports layered protection strategies and controlled changes at defined process steps.
  • Textured finger surface improves grip on tooling, fixtures, containers and packaging during aseptic and high-precision handling.
  • Beaded cuff helps donning stability and reduces tearing risk during gowning interfaces.
  • Gamma-irradiated sterile supply (SAL 10-6) with EasyTear® low-particulating packaging to reduce opening-related particulate contamination risk.
Recommended applications
  • Cleanroom cleaning and preparing (sterile glove requirement)
  • Pharmaceutical manufacturing and aseptic workflows where sterile gowning is specified
  • Medical device manufacturing and controlled assembly where cross-contamination risk is high
  • Transferring liquids and solids within controlled environments
  • Procedures requiring sustained wear comfort and stable grip
Practical gowning reminder: For sterile operations, define a glove-change frequency (time- or task-based), validate disinfection compatibility where gloves contact disinfectants, and train aseptic opening technique so packaging does not become a particle source at the point of use.
Specifications (from published product details)
SKU BASL
Cleanroom classification Class 10 / ISO 4
Material / color Natural rubber latex / Natural
Sterility / SAL Sterile / 10-6
Freedom from holes (AQL) 1.5 AQL (Inspection Level I), Performance Level 2
Glove length 295 mm / 11.6 in
Surface / grip Textured fingers
Cuff Beaded
Internal glove surface Chlorinated
Shape Hand specific
Thickness targets (single wall) Palm: 0.20 mm / 7.87 mil
Finger: 0.24 mm / 9.44 mil
Double gloving recommendation Yes, as outer glove
Tested for use with chemotherapy drugs No
Available sizes (as listed on SOSCleanroom) 6, 6.5, 7, 7.5, 8, 8.5, 9
Packaging (case) 1 pair per inner PE wallet; 1 wallet per sealed EasyTear® PE pouch; 10 pouches per sealed outer PE bag; 20 outer bags per lined carton (200 pairs)
Always validate glove selection in your process: product-contact risk, sizing and fatigue, disinfectant compatibility, grip needs, and the glove-change points required by your contamination control strategy.
Cleanroom program guidance (U.S. first, global context second)
In U.S.-based cleanroom and regulated manufacturing programs, sterile gloves are typically treated as a primary contamination-control and mix-up risk at the point of use. Tie BASL into your CCS-driven approach: controlled transfer into the clean area, defined donning/doffing steps, sterile opening technique, and a documented glove-change frequency linked to task risk (e.g., after touching non-sterile items, after disinfection cycles, or at time-based intervals). ISO 14644 terminology is commonly used in U.S. cleanroom programs alongside internal quality systems and risk-based controls.
As a secondary/global benchmark, EU GMP Annex 1 reinforces contamination control strategy (CCS) thinking for sterile operations: glove integrity and timely changes at critical steps, disciplined material transfer, and documentation that supports traceability and investigation readiness. Use Annex 1 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 designed for the same class of controlled environment and verified in your CCS.
Texwipe pairing suggestions (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.
  • ISO 4 wiping (dry): Texwipe AlphaWipe® TX1004 polyester wipers are commonly used for ISO Class 4–8 cleaning and spill control where a low-linting wipe is required (note: no wiper is truly lint-free). Learn more: Texwipe AlphaWipe TX1004
  • ISO 4 wiping (pre-wetted): When your SOP calls for consistent wetness and repeatable wipe-downs, Texwipe AlphaSat® TX1039 (70% IPA / 30% DIW) is published for ISO Class 4–8 environments and is widely used for equipment and surface wiping. Learn more: Texwipe AlphaSat TX1039
  • Precision swabbing (validation and hard-to-reach features): For targeted cleaning and TOC cleaning validation surface sampling, many programs standardize on Texwipe TX761K (Low TOC Alpha® sampling swab). Confirm swab selection, extraction requirements and recovery expectations in your method validation and CCS. Learn more: SOSCleanroom: Texwipe TX761K  |  Texwipe: TX761K overview
About Ansell and SOSCleanroom supply confidence
Ansell is a global manufacturer of hand and body protection solutions with a deep contamination-control portfolio for life sciences, microelectronics and critical manufacturing. In cleanrooms, consistency matters: formulation control, sterile packaging discipline, lot traceability, and the ability to support documentation requests when customers 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): Read the announcement.
Documentation
Product Data Sheet (PDS) – SOSCleanroom hosted (stable): bioclean-advance-basl_pds_us.pdf
Declaration of Conformity – SOSCleanroom hosted (stable): bioclean-advance-basl_eu_doc.pdf
Chemical permeation report – SOSCleanroom hosted (stable): bioclean-advance-basl_permeation_report.pdf
Manufacturer product page: Ansell BioClean™ Advance BASL
Manufacturer hosted PDS (PDF): Ansell PDS (BASL)
Manufacturer regulatory documents: Declaration of Conformity  |  Chemical permeation report
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™ Advance BASL Sterile Latex Cleanroom Gloves — Class 10 / ISO 4, Pair-Packed EasyTear™ Packaging, Double-Donning Support, Textured Fingers
Class 10 / ISO 4 Sterile (SAL 10-6) Gamma Irradiated (25 kGy) Natural Rubber Latex Powder-Free Textured Fingers 200 Pairs / Case
1. Practical solutions in a critical environment

In Class 10 / ISO 4 environments, operator touch is one of the most persistent contamination-control and product-contact risks. BASL is positioned for high-control sterile operations where glove shed, glove change discipline, and packaging behavior at point-of-use matter as much as barrier performance.

BASL uses low-particulating EasyTear™ packaging to reduce packaging-generated particulates during transfer, opening, and donning. The glove is designed to support double-donning strategies as an outer glove, with textured fingers to maintain grip during sterile manipulations and a beaded cuff to stabilize donning.

2. What this glove is for
  • Class 10 / ISO 4 clean operations where sterile gloves and strict contamination control are required
  • Aseptic processing and sterile manufacturing zones where double-donning is used as a control
  • High-precision sterile handling where tactile feedback and grip affect quality and defect risk
  • Transfer, gowning, and change-out steps where packaging performance (opening without particle events) matters
3. Selection rationale
  • ISO 4 positioning: Built for critical clean operations where glove contribution must remain tightly controlled.
  • EasyTear™ packaging: Low-particulating packaging helps reduce packaging-driven particle events during opening and donning.
  • Double-donning support: Designed for layered glove strategies where outer gloves are changed at defined steps.
  • Textured fingers: Improved grip during handling of containers, tools, fixtures, and transfer items in sterile workflows.
  • Documented cleanroom metrics: Particle, AQL, ionic content, and protein limits support QA qualification files.
  • Defined traceability: Pair-packed configuration and case structure support controlled dispensing and lot traceability.
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: Natural rubber latex
  • Color: Natural
  • Shape: Hand-specific (left/right)
  • Cuff: Beaded
  • External surface: Textured fingers
  • Internal surface: Chlorinated
  • Powder content: Powder-free
5. Specifications in context

In ISO 4 programs, sterile gloves must perform in two ways: (1) provide barrier integrity and consistent donning, and (2) avoid creating particle events through packaging behavior, glove handling, and glove change practices. The specifications below map directly to common ISO 4 operational risks: tears during donning, micro-leaks, grip loss during manipulations, and uncontrolled background contribution.

Specification Value Operational meaning
Cleanroom class Class 10 / ISO 4 Positions BASL for highly controlled clean operations where glove contribution is closely managed.
Sterility SAL 10-6 Supports sterile outer glove use when transfer and donning steps preserve sterile intent.
Freedom from holes AQL 1.5 Leak quality baseline; still requires immediate change-out for any suspected defect or touch-risk event.
Length 295 mm / 11.6" Supports gown-to-glove overlap and reduces exposed interface risk during reaching and rotations.
Thickness targets Palm 0.20 mm (7.87 mil) / Finger 0.24 mm (9.44 mil) / Cuff 0.18 mm (7.09 mil) Balanced for durability, donning stability, and controlled tactile response during sterile handling.
Tested for chemotherapy drugs No If hazardous drugs are in scope, select a glove specifically labeled/tested for your HD program requirements.
Country of origin Malaysia Relevant for supplier qualification and documentation requirements in regulated programs.
Shelf life 5 years from date of manufacture Use FEFO rotation and verify lot/expiry at point of use per SOP.
6. Cleanliness metrics

ISO 4 programs typically track glove background through particle release and extractables because these metrics show up as real deviations: unexpected particulate, residue films, and unexplained variability in sensitive processes. BASL provides documented particle and extractables baselines that can be trended and tied to lot qualification.

Metric Value Method / reference
Typical particle count ≥ 0.5 µm < 2000 counts/cm² IEST-RP-CC005.4
Protein level ≤ 50 µg/g total extractable protein Manufacturer technical data
Ionic content (examples) Chloride < 1.80 µg/cm²; Sulphate < 0.22 µg/cm²; Nitrate < 0.50 µg/cm²; Sodium < 0.08 µg/cm²; Potassium < 0.08 µg/cm² Manufacturer technical data (lot documentation supports qualification)

Operational note: In ISO 4, background control is as much technique as it is glove selection. Avoid cuff snapping, rapid dry rubbing on packaging, and uncontrolled staging of opened inner wallets.

7. Packaging, sterility, and traceability
  • Case configuration: 1 pair per inner PE wallet; 1 wallet per sealed EasyTear™ PE pouch; 10 pouches per sealed outer PE bag; 20 outer bags per lined carton (200 pairs/case)
  • Sterilization method: Gamma irradiation (25 kGy minimum dose)
  • Available sizes: 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0
  • Shelf life: 5 years from date of manufacture (verify lot/expiry on case labeling)
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: In ISO 4, treat glove packaging as a transfer item. Control how pouches are wiped, introduced, and opened. Open only what you will use in that sequence.
  • Donning without particle events: Use EasyTear™ packaging deliberately—slow, controlled opening; no ripping motions; avoid snapping cuffs. Maintain a consistent donning orientation to reduce touch events.
  • Sanitization (facility-defined): If glove sanitization is part of your program, use sterile alcohol and define reapplication triggers, wet-contact expectations, and drying rules in the SOP.
  • Double-donning: Define inner/outer glove roles. Most ISO 4 programs treat the outer glove as the “work layer” and change it at defined steps, after wipes, and after any suspect-touch event.
  • Change-out triggers: Any tear, puncture, cuff roll-down, loss of grip, tacky residue, or contact with non-qualified surfaces is an immediate change-out event.
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 TX3224 Sterile TexTra10™ 9" x 9" Polyester Cleanroom Wiper Sterile sealed-border polyester wiper supports repeatable wipe patterns with low lint and controlled extractables in critical zones.
Critical polishing / film-sensitive surfaces (ISO 4 decision sets) Texwipe TX3211 SterileWipe™ LP 9" x 9" Polyester Cleanroom Wiper Sterile continuous-filament polyester wiper used for critical cleaning and polishing where low particle generation is a priority.
Sterile gowning room wipe-downs and aseptic support areas Texwipe TX8932S Sterile TexVantage™ 12" x 12" Cellulose/Polyester Cleanroom Wiper Sterile larger-format wiper supports faster coverage on carts and staging areas while maintaining contamination-control discipline.
Detail cleaning (ports, fittings, interfaces, corners) Texwipe STX763 Sterile Gamma-Irradiated Polyester Swab Sterile swab for controlled solvent cleaning in tight geometries where wipers cannot maintain contact.
Sterile IPA delivery (routine spray application) Texwipe TX8270 Sterile 70% Isopropanol Alcohol Solution (8 oz) Sterile, ready-to-use spray format helps standardize application volume and pattern for routine glove and surface sanitization steps.
Sterile IPA bulk use (high consumption points) Texwipe TX3290 Sterile 70% Isopropanol Alcohol Solution (1 Gallon, 4/Case) Bulk sterile IPA supports high-use points; align dispensing controls to avoid over-wetting and prevent solvent-driven residue movement.
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
  • Latex sensitization risk: Natural rubber latex may cause allergic reactions. Align glove material selection to your facility allergen policy and occupational health requirements.
  • Packaging-driven particle events: Fast tearing motions, excessive handling, or opening pouches outside defined transfer steps can create avoidable particulate risk.
  • Double-donning drift: When outer-glove change triggers are not defined, operators extend use beyond the intended control model.
  • Grip loss during critical steps: Over-wetting during sanitization or mismatch between wiper substrate and soil type can create slips and rework.
  • Interface exposure: Cuff roll-down or sleeve creep can expose skin or create snag points; build overlap checks into the work sequence.
10. Other gloves to consider

These alternatives are commonly evaluated in sterile ISO 5–ISO 4 decision sets. Selection should be driven by allergen policy, tactile requirements, and the intervention model defined in your facility procedures.

11. Program fit for regulated cleanrooms
  • ISO 4 contamination control: Strong fit for programs that treat gloves and packaging behavior as a core control element in the contamination control strategy.
  • Double-donning model: Designed to support layered glove strategies where the outer glove is changed at defined steps and after touch risks.
  • Documentation-driven qualification: Suitable where QA requires cleanroom metrics (particles, extractables, protein) and defined sterility/packaging configuration for the qualification file.
  • Allergen policy alignment: Latex may be acceptable in many controlled environments, but should be explicitly governed by site policy and documented alternatives.
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