Ansell BioClean Sterile Nitrile RABS Gloves

Description
Technical Vault

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 page (SOSCleanroom): Ansell BioClean™ GGL Sterile Nitrile RABS/Isolator Gloves

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

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

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 and isolators, a glove 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 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.
Applications requiring sterile, long-sleeve glove geometry to reduce cross-contamination risk during extended manipulations.

3) Why 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 supports CCS and deviation prevention.
ISO 4 cleanroom washing/packing discipline: controls particulate burden entering the critical zone.
Disinfectant and decontamination compatibility: manufacturer documentation highlights VHP, IPA, and common disinfectant compatibility.
Supportable documentation trail: product data sheets plus declarations help QA build a defensible glove program.

Port-size note: 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. 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	Published (GGL family / example PDS)	Why it matters
Material	Nitrile (latex-free)	Reduces latex protein concerns; good chemical compatibility for gloveport work.
Sterility assurance	SAL 10^-6; gamma irradiation (25 kGy)	Aligns to validated sterile transfer expectations when glove changes are controlled and documented.
Integrity test	100% water leak tested	Practical incoming control for barrier assurance.
Cleanroom processing	Washed and packed in ISO Class 4; Class 10 / ISO 4 & EU GMP Grade A	Controls particulate burden entering the critical zone.
Disinfectant / decon	Compatibility noted with VHP, IPA, and common disinfectants	Requires site validation for exact chemistry and contact time.
Port size	Series is port-size specific. SOS example: 304 mm / 12 in. PDS example (GGL10NIT59): 254 mm / 10 in.	Hardware fit drives leak risk. Confirm before qualification.
Size (hand)	Example PDS: 9.75	Hand fit affects fatigue and tactile control.
Typical length	Example PDS: 840 mm / 33 in	Extended sleeve coverage for deep isolator manipulations.
Thickness (single wall)	Palm 0.50 mm, finger 0.60 mm, cuff 0.50 mm	Balances puncture resistance and tactile control.
Shelf life	3 years from date of manufacture	Rotate stock and protect packaging integrity.

6) Specifications in context

In gloveport work, your CCS should treat glove systems like any other critical utility: define replacement frequency, integrity checks, disinfectant exposures, and how you investigate glove-related deviations. The GGL family's published controls (sterility assurance, ISO 4 washing/packing, 100% leak testing) are the kind of upstream process signals QA teams look for when building a defensible rationale for barrier reliability.

7) Cleanliness metrics and contamination control

Control / metric	Published value	Operational use
Sterility assurance level	SAL 10^-6	Tie to glove-change intervals, sterile transfer SOPs, and packaging integrity checks.
Leak testing	100% water leak tested	Use as incoming assurance; implement routine glove system integrity checks per your CCS.
Cleanroom washing/packing	ISO Class 4	Supports reduced incoming particulate burden; maintain outer-bag control during staging.
Ions / NVR / particle counts	Not published for this listing/PDS	If required, perform qualification testing (incoming lot checks, user-conditions sampling).

Matching cleanroom consumables: For wiping and spot-cleaning alongside gloveport work, many teams standardize on low-linting, cleanroom-processed textiles and swabs.

Wipers: ITW Texwipe Vectra® Alpha® 10 (TX1010) for critical wiping applications.
Swabs: ITW Texwipe CleanFoam® B-series (TX742B) for confined-area cleaning.

SOSCleanroom is the authorized Master Distributor of ITW Texwipe for the United States market.

8) Packaging, sterilization, and traceability

Packaging uses multiple sealed PE bags (inner-to-outer) to protect sterility through staging and transfer. Sterilization is gamma irradiation (25 kGy), with a published shelf life of three years from date of manufacture. 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

Incoming inspection: verify outer packaging integrity before staging to the clean side.
Controlled transfer: bring only the required bag layer into the next cleaner area.
Ring interface discipline: install per gloveport hardware instructions; over-tensioning and misalignment are common root causes of leaks.
Disinfectant exposure control: define approved chemistry list, contact times, and maximum exposure frequency.
Integrity checks: perform glove system integrity testing at defined intervals per your CCS risk assessment.
Glove change rules: set hard limits on hours of use, manipulations, and observed stress events.

Customer SOP disclaimer: The handling guidance above is general best-practice education. It is not a substitute for your facility's written procedures, validation protocols, or quality system requirements. Always follow your site-approved SOPs and perform documented qualification before use in product-contact or aseptic manufacturing operations.

10) Common failure modes

Micro-tears at the ring interface: misaligned clamps, sharp ring edges, or over-tensioning during installation.
Punctures from tools and fixtures: tweezers and sharp-edged components can puncture nitrile without obvious visual cues.
Chemical stress cracking: cumulative exposure to aggressive chemistries outside validated compatibility can embrittle polymer over time.
Packaging compromise: small seal breaches and pinholes can invalidate sterile transfer assumptions.
Human factors: fatigue-driven over-gripping and repetitive motion increases tear probability.

11) Closest competitors

Ansell BioClean CGL (Clean, non-sterile): similar gloveport concept but positioned as "clean" rather than sterile.
Sterile elbow-length ISO 4 cleanroom gloves (non-gloveport): when the work is adjacent to but not through gloveports.

12) Program fit (standards, guidance, and audit readiness)

Glove system integrity, glove-change discipline, and documentation traceability are recurring inspection themes. EU GMP Annex 1 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, supporting program continuity, documentation access, and stable supply planning.

13) Source basis

Product pages & documentation