The Technical Vault
By SOSCleanroom
Ansell Nitrilite™ 93-311 Cleanroom Nitrile Gloves — Accelerator-Free Handling for ISO 5 / Class 100 Work
Non-sterile
Nitrile
Class 100 / ISO 5
Accelerator-free
Anti-static (EN1149)
Ansell Nitrilite™ 93-311 (Class 100 / ISO 5), non-sterile
1) Practical solutions in a critical environment
In ISO 5 / Class 100 work, gloves are not “just PPE” — they are a primary contamination-control interface. The wrong glove can add particles, ions, or handling variability that shows up as rework, yield loss, false residue positives, or cleaning loops that never stabilize. Ansell Nitrilite™ 93-311 is built for non-sterile cleanroom handling where teams need controlled-environment compatibility, an accelerator-free formulation (to reduce Type IV sensitivity risk), and a published baseline for typical particles and ionic extractables to support risk-based material selection.
U.S. customers typically anchor glove selection to FDA cGMP expectations for contamination control, validated cleaning/disinfection practices, and facility quality systems; ISO 14644 terminology is commonly used to define cleanroom classifications. EU GMP Annex 1 can be used as a secondary benchmark for CCS (Contamination Control Strategy) thinking and risk-based barrier discipline — without implying it is a U.S. legal requirement.
2) What it’s for
Nitrilite™ 93-311 is a non-sterile disposable nitrile cleanroom glove designed for compatibility with Class 100 (ISO 5) environments. Manufacturer-recommended use includes cleanroom cleaning and preparing, blending/compounding solids and liquids, spill or leakage cleanup, transferring liquids and solids, loading centrifuges and chromatography columns, assembly of parts, and weighing/dispensing solid and liquid raw materials.
3) Why should customers consider these gloves
- Class 100 / ISO 5 cleanroom compatibility for controlled-environment handling where glove-shed becomes a real defect mechanism.
- Accelerator-free, latex-protein-free nitrile formulation to reduce the likelihood of Type I (latex) and Type IV (accelerator) sensitivity issues in long shifts.
- Published typical baselines (particles and ionic extractables) to support risk-based selection, incoming qualification, and investigation triage.
- Textured fingers + optimized thickness profile for precision handling and fewer grip-compensation behaviors that can increase touch points.
- Anti-static performance (EN1149) for ESD-aware workflows where charge management and particulate control intersect.
4) Materials and construction
- Material: Nitrile (natural color), ambidextrous.
- Cuff: Beaded; typical length 300 mm / 12 in.
- External surface: Textured fingers for controlled grip.
- Internal surface: Powder-free, chlorinated (supports easier donning and reduces tack variability).
- Country of origin (published): Malaysia.
5) Specifications in context
The point of “specs” in an ISO 5 environment is not the number — it is what the number prevents. A length and cuff style that stays under the gown sleeve reduces skin exposure events. A thickness profile that maintains tactility reduces over-gripping and incidental contact with critical surfaces. AQL and cleanroom classification help you set a baseline expectation for incoming lot acceptance and complaint investigation.
| Cleanroom class |
Class 100 / ISO 5 |
| Length |
300 mm / 12 in (typical) |
| Thickness targets |
Palm 0.10 mm (3.9 mil) | Finger 0.13 mm (5.1 mil) | Cuff 0.075 mm (3.0 mil)
|
| Freedom from holes |
2.5 AQL |
| Anti-static |
Yes (EN1149) |
| Sizes (published) |
XS (5.5-6), S (6.5-7), M (7.5-8), L (8.5-9), XL (9.5-10) |
| Shelf life |
5 years |
Regulatory/standards references (published by manufacturer) include Category III, EN ISO 21420:2020, EN ISO 374-1:2016, EN ISO 374-5:2016, FDA 21 CFR 177-2600 (U.S. food contact), and ISO 14001.
6) Cleanliness metrics
These are typical published baselines intended to help teams plan method sensitivity, reduce investigation time, and keep glove choice from becoming an uncontrolled variable. Incoming qualification should be lot-based and risk-based.
| Metric |
Typical value |
Method reference |
| Particle count ≥ 0.5 µm (counts / cm²) |
< 2,400 particles / cm² |
IEST-RP-CC005.4 |
Typical ionic extractables (Concentration in µg/cm²)
| Ion |
Typical |
Ion |
Typical |
| Calcium |
0.500 |
Potassium |
0.050 |
| Chloride |
0.285 |
Sodium |
0.038 |
| Lithium |
0.0004 |
Sulphate |
0.080 |
| Magnesium |
0.050 |
Zinc |
0.300 |
| Nitrate |
0.165 |
|
|
7) Packaging, sterility, and traceability
- Packaging (published): 50 gloves per inner bag; 2 inner bags per master polybag; 10 master polybags per liner bag (1,000 gloves total).
- Sterility: Non-sterile. If your operation is aseptic and requires sterile barrier PPE, evaluate a sterile glove alternative aligned to your CCS and gowning qualification.
- Traceability: Lot/label traceability practices are typically managed at the packaging label level; confirm the labeling fields required by your quality system (lot, date code, COA/CoC expectations, and change-control requirements).
Storage guidance (published): keep out of direct sunlight; store cool and dry; keep away from ozone/ignition sources.
8) Best-practice use
In ISO 5 work, the highest-impact glove discipline is usually not “which glove” — it is when and how you change, disinfect, and handle. Consider the practices below as operational best-practice guidance to support consistent outcomes.
- Donning discipline: Don in the correct gowning sequence. Avoid snapping cuffs (particle burst). Seat the beaded cuff under the sleeve for a stable interface.
- Touch-point control: Treat “first-touch” surfaces (door hardware, carts, touchscreens) as contamination amplifiers. If you must touch them, change gloves before returning to critical work.
- Glove disinfection (when applicable): If your SOP calls for glove disinfection with IPA, use enough volume to wet the surface, allow full contact time, and let it flash off — then re-wet as required by your validated process. Do not “dry rub” (it can redistribute particles and residues).
- Change triggers: Change on schedule and on events: after touching non-controlled surfaces, after spills, after aggressive solvent contact (if swelling/softening is observed), after visible soil, and whenever tack/grip changes.
- Compatibility reality check: Nitrile handles many common cleanroom chemistries well, but strong solvents and prolonged exposure can change glove properties. If the glove is part of a validated cleaning/disinfection cycle, verify compatibility in your material qualification.
Best-in-class pairing tip (same ISO class)
If you are running ISO 5 / Class 100 work, pair glove discipline with an ISO-appropriate wiper to avoid “glove-to-surface transfer” events. A common baseline is
Texwipe AlphaWipe® TX1009, which Texwipe publishes for ISO Class 4–8 use. 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 — a practical advantage when customers cannot afford substitutions, documentation gaps, or supply interruptions.
9) Common failure modes
- “Dirty-touch loop”: touching non-controlled surfaces (carts, keyboards, door hardware) and returning to ISO 5 work without a glove change.
- Over-disinfection: repeated wetting without proper flash-off can leave film lines and drive residues into seams/crevices that later reappear as “mystery” contamination.
- Micro-tears during donning: rushing the cuff and overstretching can create tiny tears that do not look obvious but drive both contamination and safety risk.
- Wrong glove for the chemistry: extended exposure to aggressive solvents can change glove feel, grip, and barrier performance; if it feels different, treat it as a change-out event.
- Size mismatch: too small increases tear risk and hand fatigue; too large increases slip and incidental contact events.
10) Closest competitors
In practice, teams most often cross-shop based on ISO class compatibility, whether the glove is sterile vs. non-sterile, published cleanliness baselines, and ESD/anti-static behavior.
-
Valutek cleanroom nitrile (ISO 5–6 lines): commonly positioned for Class 100–1,000 applications (ISO 5–6), with multiple cuff lengths and cleanroom packaging options.
-
SHOWA nitrile cleanroom gloves (Class 100 / ISO 5 options): widely distributed and often selected where ESD-aware nitrile handling is required in ISO 5 environments.
11) Program fit
93-311 fits programs that need non-sterile ISO 5 glove discipline with accelerator-free nitrile and published cleanliness baselines. It is especially appropriate when the glove must not become a dominant background source in precision handling, cleaning, prep, or material transfer tasks.
- Pharma/biotech: Supports CCS thinking by reducing variability at a primary touch interface; if your workflow includes aseptic exposures, align glove sterility requirements to your validated process and gowning qualification.
- Medical device and lab manufacturing: Useful where ionic background, particles, and operator comfort all influence repeatability and inspection outcomes.
- Microelectronics/precision assembly: Anti-static behavior + textured fingers help reduce both charge and handling slip events that can drive defects.
Why SOSCleanroom for Ansell
Ansell is a best-in-class glove manufacturer for critical environments, and SOSCleanroom does not compromise on glove quality where cleanroom outcomes are at stake. Cleanroom Technology (June 20, 2023) reported that SOS Cleanroom Supply became an Ansell authorised distributor — a practical trust signal for customers who need continuity of supply, documentation discipline, and responsive support.
12) Customer SOP disclaimer
This Technical Vault entry is provided as general, experience-based guidance and a suggested framework for cleanroom handling, selection logic, and risk thinking. It is not a substitute for your internal SOPs, quality system requirements, or regulatory obligations. Any technique guidance, checklists, or workflow suggestions should be reviewed, adapted, validated, and approved by your organization’s qualified personnel before use.
SOSCleanroom is the source for this Technical Vault entry.
Briefed and approved by the SOSCleanroom (SOS) staff.
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Last reviewed: January 10, 2026
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