Ansell 93-401 Nitrilite Cleanroom Nitrile Gloves Class 10 (ISO 4)

Description
Technical Vault

Ansell Nitrilite™ 93-401 Cleanroom Nitrile Gloves (Natural) — Non-Sterile, Accelerator-Free Protection for Class 10 (ISO 4) Work Zones

Nitrile Class 10 / ISO 4 Accelerator-Free Antistatic 12" / 300 mm

Overview

Ansell Nitrilite 93-401 is a non-sterile, accelerator-free cleanroom nitrile glove engineered for Class 10 (ISO 4) environments where particle and ionic background can directly impact yield, reliability, and investigation time. It is built around a low-ionic/low-particulate profile for dependable product protection, with an antistatic design to support electronics and other ESD-sensitive workflows.

Why accelerator-free matters in real operations:

Many glove-related skin reactions are associated with chemical accelerators used during manufacturing. Nitrilite 93-401 is specifically positioned as accelerator-free and latex-protein-free to reduce susceptibility to Type I (immediate) or Type IV (delayed) allergic reactions in extended-wear cleanroom programs, while still delivering the durability expected from nitrile.

Where it fits in a Class 10 (ISO 4) program

Nitrilite 93-401 is commonly selected for controlled environments that demand consistent glove cleanliness and stable baseline contamination performance across incoming lots — including life sciences, biotech manufacturing support, and electronics production zones where technicians frequently touch tools, fixtures, containers, and critical surfaces.

Cleanroom cleaning and preparing tasks (benches, carts, pass-through handling)
Blending/compounding solids and liquids; weighing and dispensing raw materials
Transferring liquids and solids; spill/leakage cleanup support
Loading centrifuges and chromatography columns
Assembly of parts and general critical handling where glove contact is a primary contamination vector

Materials, surface design, and technician control

This glove uses a nitrile formulation and is processed to support cleanroom use: powder-free, chlorinated interior for improved donning and reduced tack, and textured fingertips for grip control during precision handling. The extended cuff supports better overlap with cleanroom sleeves to reduce wrist exposure during reaching and transfer tasks.

Operational note for contamination control leaders:

In high-grade areas, glove selection is only half the control. The other half is disciplined technique: consistent donning, avoiding unnecessary contact with non-controlled surfaces, changing gloves at defined intervals, and documenting glove-change triggers in the site CCS (Contamination Control Strategy). This aligns with how U.S. cGMP programs typically manage personnel as a contamination risk, while EU GMP Annex 1 can be used as a secondary benchmark for strengthening risk-based controls across facilities.

Specifications (published product details)

Cleanroom class	Class 10 / ISO 4
Sterility	Non-sterile
Material	Nitrile
Antistatic	Yes
Color	Natural
Length	300 mm / 12 in
Cuff	Extended; beaded cuff style
External surface	Textured fingers
Internal surface	Powder-free; chlorinated
Freedom from holes (AQL)	1.5 AQL (Inspection Level I)
Palm thickness	0.11 mm / 4.3 mil
Finger thickness	0.13 mm / 5.1 mil
Shape	Ambidextrous

Size range offered: XS (5.0–5.5), S (6–6.5), M (7–7.5), L (8–8.5), XL (9–9.5), XXL (10–10.5)

Packaging and stocking (what arrives on your dock)

This item is sold as a case of 1,000 gloves to support predictable replenishment and standardized gowning kit builds.

Case quantity: 1,000 gloves
Pack configuration: 50 gloves per inner bag; 2 inner bags per master polybag; 10 master polybags per 1,000-glove liner bag
Typical lead time shown on SOSCleanroom: 7–10 business days (subject to availability and program needs)

Why SOSCleanroom leads with Ansell for critical gloves

In controlled environments, gloves are not a commodity — they are a primary contamination control barrier and a primary source of direct contact with critical surfaces. SOSCleanroom positions Ansell as a best-in-class glove line because the brand maintains deep controlled-environment specialization and strong documentation discipline across cleanroom PPE programs. SOS does not compromise on glove quality for critical environments.

Third-party validation: Cleanroom Technology reported (June 20, 2023) that SOS Cleanroom Supply became an Ansell authorised distributor, reinforcing SOSCleanroom’s commitment to verified supply channels for controlled-environment customers.

Build a matched Class 10 (ISO 4) consumables set (gloves + wiping)

Customers often improve consistency by pairing cleanroom gloves with wiping consumables that are also specified for the same ISO class. 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. When you want to match Nitrilite 93-401 to the same Class 10 (ISO 4) environment, these Texwipe options are commonly selected:

Texwipe TX1060 Vectra Honeycomb10 9" x 9" Polyester Wiper (sealed border) — designed for high-performance wiping in critical environments; sealed borders are often preferred in tighter zones to reduce edge-related particle contribution.
Texwipe TX8659 Vectra Alpha 10 LT 9" x 9" Polyester Wiper — positioned for maximum performance in critical cleanroom environments.
Texwipe TX1057 AlphaSat 9" x 9" Pre-Wetted Wiper (10% IPA) — a controlled pre-wet format for consistent solution application; align solvent choice with your site validation and surface compatibility requirements.

Note: No wiper is truly lint-free. In cleanroom practice, the goal is low-linting, low-residue wiping behavior appropriate to the zone and the surface risk.

Standards and guidance context (customer education)

For U.S. customers, glove and contamination control decisions are often framed through FDA expectations (cGMP and aseptic processing principles) and ISO cleanroom classification terminology (ISO 14644). EU GMP Annex 1 can be used as a secondary/global benchmark for strengthening CCS thinking (risk-based controls, documentation, and disciplined handling) — without treating Annex 1 as a U.S. legal requirement.

ISO 14644 (cleanroom classification terminology): https://www.iso.org/standard/53394.html
FDA (cGMP / aseptic processing expectations): https://www.fda.gov
ASTM standards library (materials, testing, and cleanroom-related methods): https://www.astm.org
IEST recommended practices (contamination control and cleanroom practices): https://www.iest.org

Documentation

Download and file these documents for supplier qualification, change control packets, and customer audits.

Customer SOP disclaimer:

The handling and usage guidance above is provided as a practical starting point for customers. Your site is responsible for building, validating, and maintaining SOPs that match your cleanroom classification, risk assessment, materials compatibility, and regulatory obligations.

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 Nitrile Class 10 / ISO 4 Accelerator-free Non-sterile 12 in / 300 mm Antistatic (EN 1149)

Ansell Nitrilite™ 93-401 Cleanroom Nitrile Gloves (Natural) — Class 10 / ISO 4, Accelerator-Free Protection with Low Ionic Content and Low Particles

Shown: Nitrilite™ 93-401, natural color, extended 12-inch cuff.

1) Practical solutions in a critical environment

In a Class 10 / ISO 4 workflow, gloves are not just PPE — they are a primary contamination-control surface that touches tools, fixtures, wafers, parts, vials, and critical packaging. Ansell Nitrilite™ 93-401 is engineered to reduce common cleanroom risks (particles, ionic residue transfer, and allergy-triggering accelerators) while maintaining practical durability and dexterity for daily production handling. It is a non-sterile, accelerator-free nitrile glove designed specifically for Class 10 / ISO 4 cleanroom environments.

Manufacturer context (why Ansell matters):

Ansell is a global manufacturer of protective solutions with dedicated contamination-control product families (cleanroom gloves, garments, and accessories). For cleanroom users, that translates into documented test methods, repeatable manufacturing controls, and stable product specifications that support qualification, change control, and audit readiness. SOSCleanroom positions Ansell as a best-in-class glove line because critical environments cannot be compromised by inconsistent hand protection.

2) What it’s for

Nitrilite™ 93-401 is intended for product-protection tasks where glove-borne contamination can become a yield loss, a cosmetic defect, a test failure, or a cleanliness excursion. It is commonly selected for:

Cleanroom cleaning and preparing (non-sterile operations)
Blending and compounding solids and liquids
Spill or leakage cleanup
Transferring liquids and solids; weighing and dispensing raw materials
Loading centrifuges and chromatography columns
Assembly of parts in electronics and life sciences manufacturing

3) Why should customers consider this swab

(Glove selection drivers for ISO 4 environments.)

Accelerator-free nitrile formulation: designed to reduce susceptibility concerns tied to chemical accelerators and latex proteins.
Low ionic content + low particles: supports residue-sensitive handling where ionic transfer can disrupt cleaning outcomes, coatings, bonding, or metrology.
Class 10 / ISO 4 room fit: a practical match when the cleanroom classification is tight enough that glove quality becomes a process variable, not a commodity.
12-inch extended cuff: improves coverage when sleeves, gown cuffs, or wrist exposure are common contamination pathways.
Antistatic behavior (EN 1149): relevant where static charge can attract particles or disrupt sensitive electronics handling.

4) Materials and construction

Nitrilite™ 93-401 is made from nitrile (acrylonitrile-butadiene) and is powder-free with a chlorinated internal surface to support donning and reduce tack. The external surface is textured at the fingers to improve grip without forcing heavy texturing across the full palm (a common trade-off between grip and surface roughness). The glove is ambidextrous, with a beaded cuff and an extended 12-inch (300 mm) length.

From a contamination-control standpoint, the construction intent is straightforward: minimize loose particles, minimize extractable ions, avoid accelerator chemistry that can raise allergy concerns, and keep the glove stable enough that it does not abrade easily during routine handling.

Country of origin (published): Malaysia.

5) Specifications in context

Below is the operational spec set most cleanroom supervisors and validation teams actually care about — the parameters that affect gowning discipline, cross-contamination pathways, and day-to-day usability.

Cleanroom fit	Class 10 / ISO 4
Sterility	Non-sterile
Material	Nitrile
Color	Natural
Length	300 mm / 12 in (extended cuff)
Cuff	Beaded
Surface finish	Textured fingers (external); powder-free, chlorinated (internal)
Freedom from holes	1.5 AQL (Inspection Level I)
Thickness targets	Palm: 0.11 mm (4.3 mil) \| Finger: 0.13 mm (5.1 mil) \| Cuff: 0.08 mm (3.1 mil)
Antistatic	Yes (EN 1149 referenced in product data sheet)
Available sizes	XS (5.0–5.5), S (6–6.5), M (7–7.5), L (8–8.5), XL (9–9.5), XXL (10–10.5)
Shelf life	5 years

Packaging (published case build): 50 gloves per inner bag; 2 inner bags per master polybag; 10 master polybags (1,000 gloves) per liner bag.

6) Cleanliness metrics

Cleanroom gloves are often qualified using a mix of room fit, particle behavior, and extractables. The values below are published typicals from the Nitrilite™ 93-401 product data sheet and can be used for method planning and risk assessment.

Typical particle count

Metric	Typical value	Referenced method
Particles ≥ 0.5 µm	< 400 particles / cm²	IEST-RP-CC005.4 (referenced)

Typical ion extractables (concentration in µg/cm²)

Ion	Typical	Ion	Typical
Calcium	0.175	Potassium	0.006
Lithium	0.0001	Sodium	0.012
Magnesium	0.001	Sulphate	0.004
Nitrate	0.048	Zinc	0.017

Note: Not all ions are listed as numeric values in the published table (for example, chloride is shown as N/A). Use your internal qualification plan to confirm fit for process-critical residue limits.

7) Packaging, labeling, and traceability

For ISO 4 operations, packaging design is part of contamination control: it reduces handling events, prevents outer-carton debris from migrating inward, and supports controlled opening sequences. Nitrilite™ 93-401 is packaged as a 1,000-glove case with a published inner-bag / master-bag configuration (50 per inner bag; 2 inners per master; 10 masters per case).

Practical implication: if you stage gloves inside a gowning area, keep the outer shipper out of the clean side, transfer only the cleanroom-compatible packaging inward, and open the smallest unit that matches your shift usage to reduce time-open exposure.

Documentation available for this product includes a Product Data Sheet and Declarations of Conformity (EU and UK), which helps with supplier qualification and change control packages.

8) Best-practice use

Customer SOP disclaimer (read before implementing):

The handling steps below are general best-practice suggestions for cleanrooms. They are not a substitute for your site procedures. Your quality system, risk assessment, and validation requirements must govern glove selection, gowning order, disinfectant compatibility, and change frequency. Always follow the manufacturer’s Instructions for Use and qualification documentation, and confirm fit-for-use for your specific chemicals, surfaces, and process sensitivities.

Operator-level guidance for ISO 4 workflows:

Donning sequence: Don the first glove without snapping the cuff; seat the beaded cuff flat. If double-gloving, ensure the outer cuff overlaps the gown cuff and does not roll.
Touch discipline: Treat the glove surface like a tool: avoid contact with door handles, pens, phones, cardboard, and non-cleanroom plastics. Those contacts often introduce the highest particle loads.
Change frequency: Change gloves on defined triggers: after contact with non-cleanroom items, after spill cleanup, after chemical exposure, after a process step change (from dirty-to-clean), and whenever tactile sensitivity drops.
Wiping and solvent work: If you wipe tools or benches while gloved, avoid aggressive scrubbing that can abrade glove material. Use a low-linting cleanroom wiper and a validated solvent/disinfectant, and keep the glove in the “damp” regime rather than wet pooling.
Storage: Store away from UV/direct sunlight and ozone sources; keep cartons closed to prevent particulate ingress and odor pickup.

9) Common failure modes

In ISO 4 operations, glove issues tend to show up as contamination symptoms (particles, residues) before they show up as obvious tears. Common failure modes include:

Micro-tears from hard edges: fixture burrs, sharp stamped parts, or threaded hardware can cut thin nitrile at the fingertip.
Abrasion from repetitive wiping: using the glove as a scrub pad can generate particles and reduce barrier integrity.
Chemical incompatibility: certain solvents can swell nitrile or reduce tensile strength over time; confirm compatibility for extended exposure.
Cross-contamination via “clean/dirty” touches: handling outer packaging or tools outside the clean boundary and then returning to critical parts.
Static attraction: in dry environments, charged surfaces can attract particles; confirm your ESD controls (grounding, humidity, antistatic program) are aligned with the task.

10) Closest competitors

For Class 10 / ISO 4 nitrile glove programs, most alternatives cluster into three practical categories: sterile cleanroom nitrile (paired, hand-specific), non-sterile cleanroom nitrile (bulk-packed), and critical-environment nitrile that is “cleanroom packaged” but targeted at slightly different room classes. Commonly evaluated options include:

Kimtech™ Pure G3 Sterile White Nitrile: a sterile, hand-specific program option recommended for Class 10 / ISO 4 critical environments (often chosen when aseptic donning/sterility is required).
Valutek™ Nanotek cleanroom nitrile families: positioned for cleanroom Class 1–10 / ISO 3–4 usage depending on the specific model and packaging configuration.
Other ISO 4 nitrile cleanroom gloves (various private-label programs): evaluate carefully for published particle/ion data, bag architecture, and documentation discipline before treating them as equivalent.

Selection logic: 93-401 is a strong fit when you need ISO 4 room compatibility and published cleanliness metrics but do not require sterility. If you require sterile transfer into EU Grade A / ISO 5 aseptic zones, move to a sterile, paired, hand-specific cleanroom glove program.

11) Program fit at SOSCleanroom

SOSCleanroom is built for controlled environments and prioritizes best-in-class consumables because the critical environment cannot be compromised. SOSCleanroom also became an Ansell authorized distributor (third-party coverage noted by Cleanroom Technology, June 20, 2023), supporting continuity of supply and a documented manufacturer relationship.

How this glove pairs with wiping (same room class, ISO 4):

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. If you are running ISO 4 / Class 10 operations, glove quality and wiper quality should be aligned. Two common ISO 4-compatible, low-linting dry wipe families used in similar environments include:

Texwipe AlphaWipe® TX1009 (cut-edge polyester; designed for ISO Class 4–8 environments): https://www.texwipe.com/alphawipe-tx1009
Texwipe Vectra® Alpha® 10 family (sealed-border polyester; designed for critical cleaning applications): https://www.texwipe.com/vectra-alpha-10

Note on terminology: you will see the market use the phrase “lint-free” for wipes; in practice, no wiper is truly lint-free. In ISO 4 operations, use low-linting materials, control technique, and validate residues/particles for your process.

12) Standards and compliance notes (U.S. first, EU as a benchmark)

Cleanroom glove programs typically align to multiple layers of expectations: room classification language, test-method traceability, and risk-based contamination control. For U.S. teams, use U.S. standards and regulatory expectations as primary references, then apply EU GMP Annex 1 as a secondary/global benchmark for continuous improvement (without treating it as a U.S. legal requirement).

Cleanroom classification language: ISO 14644-1 terminology is the common reference for ISO Class 4 environments: https://www.iso.org/standard/53394.html
Glove particle testing reference: IEST-RP-CC005.4 is referenced for particle count reporting (use your internal protocol to define acceptance criteria): https://www.iest.org
ASTM methods: ASTM D3577 / ASTM D3767 / ASTM D412 are commonly referenced for holes, dimensions, and tensile properties in glove data packages: https://www.astm.org
U.S. regulatory context: FDA expectations for contamination control and materials handling are commonly navigated through FDA guidance portals and cGMP frameworks: https://www.fda.gov
EU benchmark: EU GMP Annex 1 emphasizes risk-based contamination control strategy (CCS), disciplined gowning/gloving, and documentation/traceability. Many U.S. sites use it as a continuous-improvement reference when building or upgrading aseptic practices.

If you want a glove-specific ISO spec reference for nitrile cleanroom gloves, ISO 23464:2020 is published as a nitrile cleanroom glove specification covering ISO Class 4–6: https://www.iso.org/standard/75641.html

13) Source basis

SOSCleanroom product page (primary):
https://www.soscleanroom.com/product/brands/ansell-93-401-nitrilite-cleanroom-nitrile-gloves-class-10-iso-4/

Manufacturer page:
https://www.ansell.com/us/en/products/nitrilite-93-401

Documentation (SOS-hosted PDFs):
Product Data Sheet (PDS): https://www.soscleanroom.com/content/Ansell_PDF/nitrilite-93-401_pds_us.pdf
EU Declaration of Conformity: https://www.soscleanroom.com/content/Ansell_PDF/nitrilite-93-401_nitrilite%C2%AE-93-401_eu_20230511_declaration%20of%20conformity.pdf
UK Declaration of Conformity: https://www.soscleanroom.com/content/Ansell_PDF/nitrilite-93-401_nitrilite%C2%AE-93-401_uk_20230511_declaration%20of%20conformity.pdf

Third-party validation (Ansell authorized distributor announcement):
Cleanroom Technology (June 20, 2023): https://www.cleanroomtechnology.com/sos-cleanroom-supply-becomes-ansell-authorised-distributor-209576

Companion wiping options for ISO 4 environments (manufacturer pages):
Texwipe AlphaWipe® TX1009: https://www.texwipe.com/alphawipe-tx1009
Texwipe Vectra® Alpha® 10: https://www.texwipe.com/vectra-alpha-10

Standards / bodies referenced for customer education:
ISO 14644-1 page: https://www.iso.org/standard/53394.html
FDA: https://www.fda.gov
ASTM: https://www.astm.org
IEST: https://www.iest.org

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 10, 2026 © 2026 SOSCleanroom.com