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Ansell GGL BioClean Sterile Nitrile RABS/Isolator Gloves Class 10 (ISO 4)

Ansell BioClean GGL Sterile Nitrile RABS/Isolator Gloves Class 10 (ISO 4)

$9,730.00
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GGL
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20 Gloves
Inner Packaging:
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Ansell BioClean™ GGL Sterile Nitrile RABS/Isolator Gloves — Class 10 / ISO 4 Barrier Integrity for Aseptic Interfaces
Class 10 / ISO 4 EU GMP Grade A Sterile (SAL 10-6) Nitrile (latex-free) 100% water leak tested 33" extended length Gloveport / RABS VHP / IPA compatible 20 gloves / case
Product overview
Ansell BioClean™ GGL sterile nitrile RABS/isolator gloves are engineered for gloveport applications where the glove is a physical barrier between the operator and a critical process. They are intended for Class 10 / ISO 4 cleanroom use and are described as washed and packed in ISO Class 4 conditions, with 100% water leak testing and validated sterility (SAL 10-6).
Why customers choose BioClean™ GGL
  • Built for RABS and isolator gloveports where barrier integrity is the entire point of the consumable.
  • 100% water leak tested to support glove integrity discipline and investigation readiness.
  • Validated sterility target (SAL 10-6) for sterile manufacturing interfaces.
  • Nitrile construction (no natural rubber latex), supporting allergy risk reduction and broad chemical-disinfectant compatibility programs.
  • Published guidance highlights resistance to VHP (vaporized hydrogen peroxide), IPA (isopropyl alcohol) and common disinfectants—useful when isolators run routine decon cycles.
  • Tested against ASTM D6978 for chemotherapy drug handling (note: manufacturer literature may state “not listed in the US FDA 510(k)” for this testing context).
Recommended applications
  • Restricted Access Barrier Systems (RABS) gloveport operations
  • Isolator-based aseptic processing where glove change control and leak integrity checks are part of the contamination control strategy
  • Sterile manufacturing and sterile processing workflows that require validated sterile interfaces
  • Applications involving routine disinfectant exposure (including IPA) and isolator decontamination cycles (including VHP), where compatible materials matter
Note: RABS/isolator gloves are part of the barrier system. Always qualify the glove with your gloveport hardware (ring, O-ring, clamping system), decon cycle, and process contact risk before final release.
Specifications (from published technical data)
Product code (SOS listing) GGL
Cleanroom classification Class 10 / ISO 4; EU GMP Grade A
Material / color Nitrile / White
Surface / grip Smooth external surface
Cuff Beaded
Typical glove length 840 mm / 33 in
Thickness targets (single wall) Palm: 0.50 mm / 20 mil
Finger: 0.60 mm / 24 mil
Cuff: 0.50 mm / 20 mil
Freedom from holes / integrity 100% water leak tested
Sterilization / sterility Gamma irradiation (25 kGy); SAL 10-6
Port size 304 mm / 12 in (per SOS product listing). The BioClean™ GGL series is available in multiple port sizes—confirm gloveport diameter during qualification.
Available size 9.75
Chemotherapy drug handling Tested against ASTM D6978 (manufacturer literature may note: not listed in the US FDA 510(k))
Packaging (case) 1 piece per sealed inner PE bag; 1 inner bag per sealed second inner PE bag; 1 second inner bag per sealed outer PE bag; 20 outer bags per lined inner white Correx polyethylene box (20 pieces total)
Packaging note 20 gloves / case; ships in a lined shipper format (bulk packed)
Shelf life 3 years
Storage guidance Store in a dry, cool place (<40°C) away from direct sunlight and fluorescent light
Country of origin Malaysia
Program note: For gloveport programs, dimensional fit (port diameter, ring compression, cuff capture) and leak integrity checks are operational controls, not “nice-to-haves.” Treat glove changes, handling, and documentation as part of your contamination control strategy.
Cleanroom program guidance (U.S. first, global context second)
In U.S.-based sterile manufacturing programs, gloveport consumables support contamination control, mix-up prevention, and investigation readiness. When you qualify an isolator glove, align it to your risk-based control set: incoming inspection (port size verification), defined change frequency, leak test expectations, disinfectant/decon cycle compatibility, and documented lot traceability. For terminology and classification alignment, ISO 14644 cleanroom language is commonly used alongside internal quality systems, FDA expectations, and (where applicable) USP <797> / USP <800> workflow discipline.
As a secondary/global benchmark, EU GMP Annex 1 reinforces contamination control strategy (CCS) thinking in aseptic processing: glove integrity as a critical control, controlled material transfer, and documentation that supports deviation handling and root-cause analysis. 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
In critical environments, the glove is only one part of the contamination control system. Pair gloveport PPE with ISO 4-5 appropriate wiping and precision swabbing supplies to reduce overall particle and residue risk during setup, changeovers, and routine cleaning.
Texwipe pairing suggestion (ISO 4-5 critical wiping & precision 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. For ISO 4-5 critical environments, many teams standardize on sealed-border polyester wipers and cleanroom-processed foam swabs to support disciplined surface cleaning and controlled solvent application.
  • Wipers (ISO 4-5 critical): Texwipe Vectra® Alpha® 10 sealed-border polyester wipers (example product family: TX1010 / TX1012). Low-linting performance is the goal (note: no wiper is truly lint-free). Learn more: https://www.texwipe.com/vectra-alpha-10
  • Swabs (precision cleaning): Texwipe CleanFoam® swabs (example: TX742B) for controlled solvent application in small areas and tight geometries. Texwipe CleanTips® swabs are commonly identified by trademarked light-green/green handles and “Texwipe” embossing for traceability cues. Learn more: https://www.texwipe.com/small-cleanfoam-tx742b
About Ansell and SOSCleanroom supply confidence
Ansell is a global manufacturer of hand and body protection solutions with robust controlled-environment product lines used across life sciences, electronics, and critical manufacturing. In isolator and RABS programs, consistency matters: validated sterilization, packaging discipline, and documentation that supports qualification and long-term sustainment.
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 decades serving controlled environments. As third-party validation, Cleanroom Technology reported that SOS Cleanroom Supply became an Ansell authorised distributor (Published: June 20, 2023): https://cleanroomtechnology.com/sos-cleanroom-supply-becomes-ansell-authorised-distributor-209576
Documentation
Product Data Sheet (PDS) – SOSCleanroom hosted (stable): bioclean-nitrile-sterile-rabs-isolator-gloves-ggl10nit59_pds_us.pdf (If you require port-size-specific documentation for your gloveport hardware, contact SOSCleanroom for the exact matching PDS.)
Declaration of Conformity (SOSCleanroom hosted): GGL global declaration.pdf
GMP statement (SOSCleanroom hosted): GGL GMP Statement Global.pdf
Manufacturer reference (series datasheet link): GGL global PDS (Ansell)
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 11, 2026
© 2026 SOSCleanroom.com
The Technical Vault
By SOSCleanroom
Class 10 / ISO 4 processing Sterile (SAL 10-6) RABS / isolator gloveport use 100% water leak tested VHP / IPA compatibility noted
Ansell BioClean GGL sterile nitrile RABS/isolator gloveports: barrier integrity, sterility assurance, and glove-change discipline
Ansell BioClean GGL sterile nitrile RABS/isolator glove (series image)
Series image for identification. Gloveport/port-size configuration depends on isolator hardware and the ordered part number.
1) Practical solutions in a critical environment
In RABS (Restricted Access Barrier Systems) and isolators, a glove is not “just PPE.” It is a primary barrier that can become the highest-risk interface between a Grade A/ISO 5 critical zone and the surrounding area. The Ansell BioClean GGL sterile nitrile RABS/isolator glove family is built for that exact role: validated sterility (SAL 10-6), ISO Class 4 processing discipline, and integrity controls (100% water leak testing) that support a contamination-control strategy (CCS) built around barrier reliability and repeatable glove-change practices.
2) What it’s for
  • Aseptic manipulations through gloveports in isolators and RABS where glove integrity is directly tied to sterility assurance.
  • Operations exposed to routine disinfectant use and decontamination methods (including VHP cycles) where material compatibility matters.
  • High-consequence environments (sterile fill-finish, aseptic compounding/processing, biotech, sterile device assembly) where glove failure is a deviation event, not an inconvenience.
  • Applications requiring sterile, long-sleeve glove geometry (arm-length coverage) to reduce cross-contamination risk during extended manipulations.
3) Why should customers consider these gloves
  • Sterility assurance you can operationalize: SAL 10-6 supports validated sterile workflows where glove changes are planned and documented.
  • Barrier integrity emphasis: 100% water leak testing is a pragmatic control for liquid barrier assurance before the glove ever reaches your line.
  • ISO 4 cleanroom washing/packing discipline: processing and packaging controls reduce particulate burden entering the critical zone.
  • Disinfectant and decontamination compatibility is addressed: manufacturer documentation highlights compatibility with VHP, IPA, and common disinfectants—useful for CCS risk assessments.
  • Supportable documentation trail: product data sheets plus supporting declarations help QA build a defensible glove program.
Port-size note (accuracy-first): The SOSCleanroom product configuration for the GGL series shows a selectable port size (example shown: 304 mm / 12 in), while the linked manufacturer PDS example is for GGL10NIT59 (10 in / 254 mm port). The GGL series includes multiple port sizes—confirm the exact port size and request the matching part-number PDS for your isolator glove ring before validation and procurement.
4) Materials and construction
The BioClean GGL sterile RABS/isolator gloves are nitrile, white, ambidextrous, with a smooth external surface and a beaded cuff. This construction targets controlled tactile feedback and repeatable donning/handling inside gloveports while maintaining a robust liquid barrier. Because gloveports create concentrated stress at the ring interface, your real-world performance will be driven as much by gloveport hardware fit and installation practices as by the glove polymer itself.
5) Specifications at-a-glance
Parameter What’s published for the GGL family / example PDS Why it matters in ISO 4 barrier work
Material Nitrile (latex-free) Reduces latex protein concerns; supports long wear in gloveports with good chemical compatibility.
Sterility assurance SAL 10-6; gamma irradiation (25 kGy) Aligns to validated sterile transfer and manipulation expectations when glove changes are controlled and documented.
Integrity test 100% water leak tested Practical incoming control for barrier assurance (supports CCS and deviation prevention).
Cleanroom processing Washed and packed in ISO Class 4 cleanroom; listed as Class 10 / ISO 4 & EU GMP Grade A (PDS) Controls particulate burden entering the critical zone; supports sterile manufacturing expectations for barrier PPE.
Disinfectant / decon exposure Compatibility noted with VHP, IPA, and common disinfectants (PDS narrative) Reduces risk of polymer degradation in routine cycles; still requires site validation for your exact chemistry and contact time.
Port size Series is port-size specific. SOS listing example shows 304 mm / 12 in. PDS example (GGL10NIT59) lists 254 mm / 10 in. Hardware fit drives leak risk and fatigue. Confirm ring size and ordered part number before qualification.
Size (hand) Example PDS size: 9.75 Hand fit affects fatigue and tactile control—two drivers of unintended contact and micro-tears.
Typical length Example PDS: 840 mm / 33 in Extended sleeve coverage reduces forearm exposure and helps maintain barrier continuity during deep isolator manipulations.
Thickness (single wall) Example PDS targets: palm 0.50 mm, finger 0.60 mm, cuff 0.50 mm Balances puncture resistance and tactile control; finger thickness matters most in pinch/grip operations.
Shelf life Example PDS: 3 years from date of manufacture Supports inventory planning, but rotate stock and protect packaging integrity to avoid sterility and polymer aging risks.
6) Specifications in context
In gloveport work, “good gloves” are the starting point, not the finish line. Your CCS should treat glove systems like any other critical utility: define a replacement frequency, define integrity checks, define disinfectant exposures, and define how you investigate glove-related deviations. The GGL family’s published controls (sterility assurance, ISO 4 washing/packing discipline, and 100% leak testing) are the kind of upstream process signals QA teams look for when they are building a defendable rationale for barrier reliability—especially where Annex 1 expectations emphasize glove/system integrity testing and risk-based controls.
7) Cleanliness metrics and contamination control (table view)
For gloveport gloves, the “cleanliness metric” that most often drives investigations is integrity (leaks, micro-tears, ring-interface seal failures), followed by sterility assurance and incoming packaging integrity. Published particulate, ion, and NVR values are not always provided for gloveport glove families—so your qualification should emphasize incoming inspection and in-process integrity controls.
Control / metric Typical published value / status How to use it operationally
Sterility assurance level SAL 10-6 (published) Tie to glove-change intervals, sterile transfer SOPs, and packaging integrity checks.
Leak testing 100% water leak tested (published) Use as incoming assurance; still implement routine glove system integrity checks per your CCS (and hardware capability).
Cleanroom washing/packing class ISO Class 4 washed/packed (published) Supports reduced incoming particulate burden; maintain outer-bag control during staging and transfer.
Ions / NVR / particle counts Not published for this listing/PDS excerpt If required for your process, perform qualification testing (incoming lot checks, user-conditions sampling) rather than assuming values.
Matching best-in-class cleanroom consumables (ISO 4 mindset): For wiping and spot-cleaning tasks that happen alongside gloveport work (staging shelves, non-product-contact tool exteriors, glove ring areas outside the critical zone), many teams standardize on low-linting, cleanroom-processed textiles and swabs with tight process controls. Because no wiper is truly lint-free, focus on low-linting materials with controlled edge construction and documented cleaning processes.
  • Wipers: ITW Texwipe Vectra® Alpha® 10 family (example: TX1010) for critical wiping applications: https://www.texwipe.com/vectra-alpha-10-tx1010
  • Swabs: ITW Texwipe CleanFoam® B-series (example: TX742B) for confined-area cleaning: https://www.texwipe.com/small-cleanfoam-tx742b
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.
8) Packaging, sterilization, and traceability
The published packaging configuration for the referenced sterile PDS example uses multiple sealed polyethylene (PE) bags (inner-to-outer) to protect sterility through staging and transfer. Sterilization is listed as gamma irradiation (25 kGy), with a published shelf life of three years from date of manufacture (PDS example). For QA documentation, the series is supported by an EU Declaration of Conformity (covering GGLxxNIT59) and additional quality declarations posted with the product documentation.
9) Best-practice use (technician-focused)
Gloveport gloves succeed or fail on disciplined handling. These practices are commonly embedded in CCS-driven programs:
  • Incoming inspection: verify outer packaging integrity (tears, pinholes, compromised seals) before staging to the clean side.
  • Controlled transfer: bring only the required bag layer into the next cleaner area; do not “carry the outside in.”
  • Ring interface discipline: install per gloveport hardware instructions; over-tensioning and misalignment are common root causes of leaks and early tearing.
  • Disinfectant exposure control: define the approved chemistry list, contact times, and maximum exposure frequency; reassess after changes in disinfectant rotations (including sporicidal rotations).
  • Integrity checks: perform glove system integrity testing at defined intervals where required/feasible (beginning/end of batch, or per your CCS risk assessment).
  • Glove change rules: set hard limits (hours of use, number of manipulations, observed stress events) and treat “near misses” (snags, sharp-edge contacts) as change triggers.
Customer SOP disclaimer (read before adopting): The handling guidance above is provided as general best-practice education to support customer training and risk-based process design. It is not a substitute for your facility’s written procedures, validation protocols, or quality system requirements. Always follow your site-approved SOPs, verify compatibility for your specific disinfectants/decontamination method, and perform documented qualification (including gloveport fit and integrity testing methodology) before use in product-contact or aseptic manufacturing operations.
10) Common failure modes
  • Micro-tears at the ring interface: caused by misaligned clamps, sharp ring edges, or over-tensioning during installation.
  • Punctures from tools and fixtures: tweezers, sharp-edged components, and burrs can puncture nitrile without obvious visual cues.
  • Chemical stress cracking: cumulative exposure to aggressive chemistries outside validated compatibility (or excessive contact time) can embrittle polymer over time.
  • Packaging compromise: small seal breaches and pinholes can invalidate sterile transfer assumptions—inspect every layer.
  • Human factors: fatigue-driven over-gripping and repetitive motion increases tear probability; confirm ergonomic fit and glove sizing.
11) Closest competitors
Keep competitor evaluations mechanism-based: sterility assurance approach, integrity-testing controls, ring-fit options, and documentation discipline.
  • Ansell BioClean CGL (Clean, non-sterile) RABS/isolator glove family: similar gloveport concept, but positioned as “clean” rather than sterile—useful where your process sterilizes the isolator environment and glove system as a whole or where sterile packaging is not required for the glove component.
  • Sterile elbow-length ISO 4 cleanroom gloves (non-gloveport) for open RABS support work: when the work is adjacent to, but not through, gloveports, sterile ISO 4 gloves (e.g., sterile nitrile lines) may be more appropriate than a gloveport configuration.
12) Program fit (standards, guidance, and audit readiness)
In the U.S., sterile manufacturing and aseptic processing expectations are typically anchored in FDA cGMP guidance and your internal quality system. Glove system integrity, glove-change discipline, and documentation traceability are recurring inspection themes because they directly affect contamination risk. Internationally, EU GMP Annex 1 is a widely used benchmark that raises the bar on CCS formality, barrier integrity testing, and risk-based justification for how glove systems are installed, monitored, and replaced. Annex 1 is not a U.S. legal requirement, but it is a useful framework for tightening your CCS and reducing deviation rates.
SOSCleanroom + Ansell documentation reliability: Cleanroom Technology reported (June 20, 2023) that SOS Cleanroom Supply became an Ansell authorized distributor. That authorization supports program continuity, documentation access, and stable supply planning for QA-controlled glove programs.
13) Source basis
Product pages & documentation used to build this entry
  • SOSCleanroom product page (GGL series): https://www.soscleanroom.com/product/brands/ansell-ggl-bioclean-sterile-nitrile-rabs-isolator-gloves-class-10-iso-4/
  • Manufacturer PDS (SOS-hosted stable copy): “BioClean Nitrile Sterile RABS/Isolator Gloves GGL10NIT59 – Product Data Sheet” (© 2022 shown on document): https://www.soscleanroom.com/content/Ansell_PDF/bioclean-nitrile-sterile-rabs-isolator-gloves-ggl10nit59_pds_us.pdf
  • EU Declaration of Conformity (SOS-hosted): https://www.soscleanroom.com/content/Ansell_PDF/bioclean-nitrile-sterile-rabs-isolator-gloves-ggl10nit59_bioclean%E2%84%A2-ggl10nit59_eu_20230512_declaration%20of%20conformity.pdf
  • GMP declaration document (SOS-hosted): https://www.soscleanroom.com/content/Ansell_PDF/gmp.pdf
  • Ansell manufacturer page (reference): https://www.ansell.com/us/en/products/bioclean-nitrile-sterile-rabs-isolator-gloves-ggl10nit59
  • Ansell PDS link (reference): https://www.ansell.com/-/media/projects/ansell/website/pim/product-assets/bioclean/ggl10nit59/ggl10nit59-global-pds.ashx
  • Cleanroom Technology validation (Ansell authorized distributor): https://cleanroomtechnology.com/sos-cleanroom-supply-becomes-ansell-authorised-distributor-209576
  • FDA aseptic processing guidance (U.S. primary reference): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sterile-drug-products-produced-aseptic-processing-current-good-manufacturing-practice
  • EU GMP Annex 1 (European Commission): https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf
  • ASTM (standards body reference): https://www.astm.org
  • IEST (recommended practices reference): https://www.iest.org
  • ISO 14644-1 overview page (ISO standard reference): https://www.iso.org/standard/53394.html
  • ITW Texwipe supporting references (paired consumables): https://www.texwipe.com/vectra-alpha-10-tx1010 and https://www.texwipe.com/small-cleanfoam-tx742b
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.
If you need additional information please try our SOSCleanroom specific AI ChatBot which draws from our extensive cleanroom specific libraries.
Last reviewed: January 11, 2026
© 2026 SOSCleanroom.com