The Technical Vault
By SOSCleanroom
Ansell AccuTech® 91-225 Sterile Latex Cleanroom Gloves — ISO 5 / EU GMP Grade A/B Dexterity, Viral Protection Positioning, and Low-Protein Latex Control
Sterile (gamma, 25 kGy)
Class 100 / ISO 5 cleanroom compatible
Natural rubber latex (powder-free)
12" length (300 mm), extended cuff
AQL 0.65 (freedom from holes)
200 pairs/case (bulk packed)
Product thumbnail (for quick visual ID at point-of-use).
1) Practical solutions in a critical environment
In ISO 5 / Grade A-type workflows, glove selection is not a comfort decision — it is a contamination-control control point. AccuTech® 91-225 is positioned for sterile, aseptic handling where fingertip sensitivity, consistent donning behavior, and predictable barrier integrity matter as much as sterility itself. The published combination of low particle count, low extractable protein, and anatomic design is intended to reduce variability between operators and across shifts.
Why SOSCleanroom carries Ansell for critical environments: SOSCleanroom does not compromise on glove quality where the environment cannot be compromised. Ansell is a best-in-class glove line with deep life-sciences focus, documented product controls, and broad critical-environment adoption. Cleanroom Technology (June 20, 2023) reported SOS Cleanroom Supply became an Ansell authorised distributor, reinforcing documented supply-channel integrity.
2) What it’s for
Ansell positions AccuTech® 91-225 for aseptic applications in biotechnology, pharmaceutical manufacturing, lab R&D, and controlled/critical environments, including tasks such as aseptic filling/labeling, compounding and blending, sampling, and transfer steps where sterility and handling precision must be maintained.
- ISO 5 workzones, restricted-access barrier systems, isolators, and laminar-flow critical areas where glove shedding and technique drift can become investigation triggers.
- Sterile material handling: staging, set-up, and manipulations where dexterity reduces the temptation to “re-grip” or over-handle items.
- Documented sterile workflows where lot traceability, packaging configuration, and published cleanliness data support qualification rationale.
3) Why should customers consider these gloves
- ISO 5 / Grade A compatibility posture: The published positioning explicitly targets Class 100 / ISO 5 and EU GMP Grade A/B sterile cleanrooms.
- Published particle control: Typical particle count reported as < 3500 counts/cm² at ≥0.5 µm (test method: IEST-RP-CC005.4).
- Low extractable protein: Protein level is published at 50 µg/g or less to help reduce protein-driven latex allergy risk (still requires facility latex policy controls).
- Anatomic design + textured fingers: Hand-specific shape with textured fingertips supports controlled grip without excessive force (a common driver of glove micro-tears and operator fatigue).
- Bulk-packed sterile efficiency: 200 pairs/case configuration can reduce handling steps vs. small-case formats when your gowning station volume is high.
4) Materials and construction
AccuTech® 91-225 is made from natural rubber latex (powder-free) with an anatomic shape (straight fingers) and a straight cuff. The inside surface is listed as chlorinated, which typically supports smoother donning and reduced tack — particularly relevant when double-gloving or when gowning-room humidity swings.
Latex note (operational): Low-protein latex reduces protein-related risk but does not eliminate latex sensitization concerns. If your CCS or EHS program restricts latex, treat this glove as a non-starter and shift to sterile nitrile or polyisoprene alternatives (see “Closest competitors” for ISO 5 options).
5) Specifications in context
The table below lists published values and what they mean in day-to-day sterile handling. In ISO 5 operations, the goal is not “thick” or “thin” — it is the stable balance between tactile control, tear resistance, and low shedding when technique is under time pressure.
| Attribute |
Published value |
Why it matters operationally |
| Cleanroom compatibility |
Class 100 / ISO Class 5; EU GMP Grade A/B (sterile cleanrooms) |
Sets expectation that the glove is intended for the highest-risk zones where personnel are the dominant contamination source. |
| Length |
300 mm / 12 in |
Extended cuff reduces wrist exposure and helps interface with sleeve cuffs and taped gowning systems. |
| Freedom from holes |
AQL 0.65 |
Lower AQL supports barrier confidence; still requires routine glove changeout discipline and inspection triggers. |
| Thickness (single wall) |
Finger 0.23 mm (9.1 mil); Palm 0.22 mm (8.66 mil); Cuff 0.25 mm (9.8 mil) |
Thickness drives tactile feel, tear resistance, and fatigue; cuff thickness supports gown interface durability. |
| Surface / interior |
Textured fingers; internal surface chlorinated |
Texture improves grip control; chlorination generally eases donning and reduces tack in double-glove programs. |
| Sterilization |
Gamma irradiation (25 kGy) |
Aligns with sterile consumable handling; treat package integrity and opening technique as part of sterility assurance at point-of-use. |
| Shelf life |
5 years |
Supports long qualification windows when storage controls are maintained (cool, dry, away from ozone/sunlight). |
| Country of origin |
Malaysia |
Useful for supplier qualification files and incoming inspection documentation. |
6) Cleanliness metrics
Published cleanliness metrics are most valuable when you use them to support method selection, qualification rationale, deviation investigations, and change-control decisions. Do not treat these as facility acceptance limits; qualify against your internal criteria and documented methods.
| Metric |
Typical / published value |
Test method / context |
| Particles (releasable) |
< 3500 counts/cm² at ≥0.5 µm |
IEST-RP-CC005.4 (as published on the technical data sheet) |
| Extractable protein |
50 µg/g or less |
Published protein level; supports latex risk management posture (facility policy still required) |
| Ionic extractables |
Not published / not stated |
If ionic control is critical (e.g., sensitive assays, electronics), confirm with your quality system or supplier documentation |
| NVR (non-volatile residue) |
Not published / not stated |
For residue-sensitive work, validate via your internal extraction/inspection method |
| Antistatic |
Not tested |
If ESD control is required, select an ESD-validated glove system rather than assuming performance |
7) Packaging, sterility and traceability
- SOSCleanroom packaging (bulk packed): 200 pairs/case; 10 bags/case; 20 pairs/bag; double bagged to support cleaner introduction workflow.
- Manufacturer packaging (technical data sheet): 1 pair per inner poly pack; 10 inner poly packs per inner polybag; 5 outer polybags per bag; 4 bags per master bag; 1 master bag (200 pairs) per carton/case.
- Sterilization method: Gamma irradiation (25 kGy).
- Traceability: In investigations and batch record support, capture glove lot, gowning time, double-glove status, and changeout timing — then link to cleaning/wipe lots used in the same zone.
- Storage controls: Keep out of direct sunlight; store cool and dry; keep away from ozone/ignition sources (per published storage guidance).
8) Best-practice use
High-grade sterile gloves perform best when the technique is controlled. In ISO 5, personnel are the dominant contamination source; glove discipline is a core control in U.S. aseptic processing expectations and aligns with EU GMP Annex 1’s emphasis on risk-based contamination control and consistent gowning behaviors.
- Donning sequence: Open the sterile inner packaging in a way that prevents the glove exterior from contacting the gown front, bench edge, or cart lip. If the glove touches a non-sterile surface, discard — do not rationalize.
- Double-glove logic: In aseptic work, treat the outer glove as the sacrificial control surface. Change the outer glove on a timed interval and on any contact event (door handle, cart handle, label printer, or suspected non-sterile touch).
- Changeout triggers: Replace immediately for any nick/tear suspicion, tacky feel changes, splash events, or after extended high-force manipulations (stoppers, crimping, stubborn caps) where micro-tears can occur.
- Alcohol wiping of gloved hands: If your CCS includes periodic glove sanitization, use validated sterile wipes/solutions, control dwell time, and prevent over-wetting that can drive drips or re-deposit residues.
- Latex program controls: If latex is allowed, document allergen posture and signage; segregate latex vs. latex-free work areas if required by your EHS program.
Matching ISO 5 gloves with ISO 5 cleaning consumables (recommended pairings):
For over 35 years, SOS and ITW Texwipe have been close partners, and SOSCleanroom is the authorized Master Distributor of ITW Texwipe for the United States market. To keep your ISO 5 program aligned, pair sterile glove handling with sterile, low-linting wipe and swab systems designed for ISO Class 3-5 environments:
- Sterile wipe-down (ISO 3-5): Sterile AlphaSat® 10 (70% USP IPA) — designed to clean ISO Class 3-5 cleanrooms, including isolators and BSCs.
- Dry wipe for staging/transfer where sterility is not required: Texwipe TX1009 AlphaWipe® sealed-edge polyester wiper (published ISO Class 4-5 positioning; confirm with your internal SOP scope).
- Sterile detail cleaning/swabbing: Texwipe STX708A Sterile CleanFoam® swab option when you need a sterile foam contact tool for small features (individually wrapped).
9) Common failure modes
- Package handling breaches: Sterile glove performance is defeated by poor opening technique. Train an “inner pack only touches sterile field” rule and enforce discard on contact events.
- Technique drift: Operators differ on how often they change gloves, how they sanitize, and what they consider a “contact event.” Standardize with a short technique card (interval + triggers) and audit it.
- Over-confidence in AQL: AQL supports confidence; it does not replace routine changeout and visual/tactile inspection for snags and micro-tears.
- Latex policy conflict: If latex is restricted by customer/site requirements, substitution under pressure can create deviation risk. Lock in approved alternatives and keep qualified stock available.
- Misapplied chemical expectations: This glove is not positioned for chemotherapy drug handling (published: No). For aggressive chemistries or cytotoxic exposures, select a glove validated for those hazards and document the rationale.
10) Closest competitors
For ISO 5 sterile glove programs, the meaningful differentiators are material (latex vs. nitrile vs. polyisoprene), published cleanliness/particle data, packaging/sterility format, and supply continuity (to avoid unqualified substitutions).
-
Latex-free ISO 5 alternative (sterile nitrile):
Ansell TouchNTuff® 93-700 (Class 100 / ISO 5) — consider when latex restriction or allergy posture drives material selection.
-
Latex-free ISO 5 alternative (sterile polyisoprene):
Ansell TouchNTuff® 83-500 (Class 100 / ISO 5) — common selection when users want latex-like feel without natural rubber latex.
-
Within-latex sterile ISO 5 option set (comfort/dexterity positioning):
Evaluate other sterile latex cleanroom gloves based on published particle/protein data, cuff length needs, and your gown interface/taping method.
11) Critical environment fit for these gloves
AccuTech® 91-225 is a strong fit when your work is sterile and tactile: aseptic manipulations, sampling, transfers, and set-ups where loss of fingertip feedback can drive re-gripping, over-handling, and technique drift. The published ISO 5 / Grade A/B positioning and particle/protein metrics support qualification documentation in audit-heavy programs.
For U.S.-based programs, align your glove controls with FDA expectations for contamination control and documented aseptic practices, and where applicable, USP <797>/<800> facility requirements for sterile compounding and hazardous drug controls. EU GMP Annex 1 can be used as a secondary benchmark for continuous improvement without implying it is a U.S. legal requirement.
12) 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 surfaces, solvents, cleanliness limits, inspection methods, and risk profile. In short: use these best-practice suggestions to strengthen your SOPs—not to replace them.
13) Source basis
SKU-specific pages and PDFs
- SOSCleanroom product page (AccuTech 91-225): https://www.soscleanroom.com/product/brands/ansell-91-225-accutech-sterile-latex-gloves-class-100-iso-5/
- SOS-hosted Ansell Technical Data Sheet (AccuTech 91-225, “TECHNICAL DATA SHEET”, © 2022 Ansell): https://www.soscleanroom.com/content/Ansell_PDF/accutech-91-225_pds_us.pdf
- SOS-hosted EU Declaration of Conformity (AccuTech 91-225; includes standards list and dates): https://www.soscleanroom.com/content/Ansell_PDF/accutech-91-225_accutech%C2%AE-91-225_eu_20230511_declaration%20of%20conformity.pdf
- Manufacturer product page (Ansell): https://www.ansell.com/us/en/products/accutech-91-225
- Manufacturer Technical Data Sheet link (Ansell): https://www.ansell.com/-/media/projects/ansell/website/pim/product-assets/accutech/accutech-91-225/accutech-91-225-pds.ashx
Complementary ISO 5 cleaning consumables (for matching program control)
- Sterile AlphaSat® 10 category page (ISO Class 3-5 positioning published): https://www.soscleanroom.com/categories/wipers/pre-wetted-wipers/sterile/sterile-alphasat-10/
- Texwipe TX1009 product page (dry sealed-edge polyester wiper): https://www.soscleanroom.com/product/wipers/texwipe-tx1009-9x9-alphawipe-sealed-edge-polyester-cleanroom-wiper/
- Sterile CleanFoam® swab technical sheet (STX708A/STX712A sterile foam swabs): https://www.soscleanroom.com/content/texwipe_pdf/TDS_SterileFoam_2014.pdf
Standards and regulatory bodies referenced for context
- International Organization for Standardization (ISO) cleanroom classification context (ISO 14644-1:2015): https://www.iso.org/standard/53394.html
- FDA (Food and Drug Administration): 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/
Third-party trust reference (Ansell channel validation)
Cleanroom Technology (June 20, 2023): https://cleanroomtechnology.com/sos-cleanroom-supply-becomes-ansell-authorised-distributor-209576
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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