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Ansell 83-500 TouchNTuff Sterile Polyisoprene Gloves Class 100 (ISO 5)

Ansell 83-500 TouchNTuff Sterile Polyisoprene Gloves Class 100 (ISO 5)

$582.50
SKU: 83-500 7 - 10 Business Days
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Important Availability Notice: Ansell and Kimberly-Clark items, including stock items and those with 7–10 day lead times, may be delayed up to 30 days. Please contact us to confirm availability. Normal shipping is expected to resume by 1st Nov 2026

Ansell TouchNTuff® 83-500 Sterile Polyisoprene Cleanroom Gloves (White) — ISO 5/Class 100 “Second-Skin” Comfort for Double-Gloving and Latex-Sensitive Workflows
Sterile (Gamma, 25 kGy) Class 100 / ISO 5 EU GMP Grade A Polyisoprene (no natural rubber latex proteins) 300 mm / 12 in AQL 0.65 (Inspection Level I) SureFit™ beaded cuff DERMASHIELD™ inner coating

TouchNTuff® 83-500 is a sterile, ultra-soft polyisoprene cleanroom glove engineered for Class 100 (ISO 5) / EU GMP Grade A environments where operator comfort and contamination control must coexist. It delivers the stretch and tactile “second-skin” feel associated with natural rubber latex, but is formulated without natural rubber latex proteins to help reduce Type I latex allergy concerns. It is purpose-built for prolonged wear and controlled double-gloving strategies where fatigue and loss of dexterity can become real process risks.

In practical ISO 5 operations, the glove is a primary barrier and a primary contamination vector at the same time. 83-500 is designed to support disciplined gowning, aseptic technique, and repeatable handling in high-sensitivity workflows such as sterile compounding support activities, aseptic fill/finish adjacent tasks, biotech processing, and critical lab environments. It is gamma irradiated (25 kGy) and supplied in clearly defined sterile packaging configurations to support traceability and audit readiness.

Why customers choose TouchNTuff® 83-500 in ISO 5 spaces
  • Comfort that supports compliance: Ultra-soft polyisoprene is intended to minimize fatigue during long wear, helping technicians stay consistent on delicate tasks.
  • Latex-protein avoidance: Polyisoprene is stated by the manufacturer as not made from natural rubber latex proteins, reducing Type I latex allergy concerns.
  • ISO 5 / Grade A suitability: Designed and tested for Class 100 (ISO 5) / EU GMP Grade A controlled environments.
  • Double-gloving friendly: Recommended for double gloving (as an outer glove or underglove) when your risk assessment and gowning practice calls for it.
  • Defined sterile processing: Gamma irradiation at 25 kGy supports sterile supply expectations for critical operations and documented contamination control strategies.
Standards context for ISO 5 glove selection

For U.S. customers, glove selection and glove-change discipline typically sits inside a broader contamination control program aligned to FDA cGMP expectations and site SOPs (often including aseptic processing and sterile handling guidance). ISO 14644 terminology is commonly used to define room classification and behavior. EU GMP Annex 1 is frequently referenced as a secondary, global benchmark for risk-based contamination control strategy (CCS), gowning rigor, and documentation discipline — but it is not a U.S. legal requirement.

In practice, ISO 5 glove performance is only “real” when paired with consistent behavior: correct donning, controlled touch technique, defined glove-change triggers, and compatible cleaning/disinfection steps that are validated at your site. This is where best-in-class gloves earn their value — they reduce variability so your process controls can do their job.

Materials and design details that impact real-world handling
  • Material: PI (Polyisoprene), white.
  • Hand form: Anatomic with curved fingers, supporting dexterity and reduced hand strain in repetitive manipulation.
  • Outer surface: Smooth finish for controlled grip and consistent wipe-down behavior.
  • Inner surface: Polymer coated with DERMASHIELD™ technology to support donning and wear comfort.
  • Cuff: Beaded with SureFit™ technology for stable cuff behavior during gowning and extended wear.
Technical specifications (published)
Cleanroom classification Class 100 / ISO 5 & EU GMP Grade A
Sterilization method GAMMA irradiation (25 kGy)
Length 300 mm / 12 in
Freedom from holes 0.65 AQL (Inspection Level I)
Thickness (target single wall) Palm: 0.21 mm / 8.26 mil  |  Finger: 0.23 mm / 9.05 mil  |  Cuff: 0.17 mm / 6.69 mil
Typical particle count ≥0.5 µm: ≤ 2500 counts/cm² (test method: IEST-RP-CC005.4)
Chemotherapy drug testing Yes (manufacturer-stated)
Anti-static Not tested
Powder content Powder-free
Shelf life 5 years
Country of origin Malaysia
Quality / regulatory references (as listed by manufacturer) Includes ISO 13485, ISO 9001:2015, ASTM D7160, ISO 11193, EN ISO 21420:2020, EN ISO 374 series, EN 556-1:2001, and others (consult the IFU / datasheet for the full list).
Size / reorder cross-reference (manufacturer-published)
Size Reorder No.
5.5 83500055
6.0 83500060
6.5 83500065
7.0 83500070
7.5 83500075
8.0 83500080
8.5 83500085
9.0 83500090
Packaging configuration (case)

Case quantity is 200 pairs. Packaging is structured to support sterile presentation and inventory control:

  • 1 pair per inner polybag
  • 10 pairs per outer polybag
  • 5 polybags per master polybag
  • 4 master polybags per carton
  • 200 pairs per carton
Technician-focused handling guidance for ISO 5 success
  • Donning discipline: Open inner packaging only at point-of-use. Avoid snapping, shaking, or “airing out” gloves — those habits can increase particle movement in the work zone.
  • Double-gloving logic: If your risk assessment calls for double gloving, treat the outer glove as a frequently changed consumable. Change on schedule, after any suspected compromise, and before entering the most critical manipulations.
  • Defined touch policy: In ISO 5, “clean” is not a feeling — it is a rule set. If a glove contacts a non-qualified surface (door hardware, carts, phones, pens, cardboard, unvalidated wipes, etc.), change it.
  • Cleaning/disinfection compatibility: Use only site-approved agents and validated contact times for glove wipe-down. Avoid assuming compatibility with aggressive solvents or disinfectants without validation.
  • Storage integrity: Store per manufacturer guidance: cool and dry, away from direct sunlight, ozone sources, and ignition sources.
About Ansell and why SOSCleanroom stocks this glove line

Ansell is a long-established global manufacturer focused on hand and body protection for controlled environments, life sciences, and industrial safety. In cleanrooms, that matters because manufacturing consistency, validation documentation, and traceable packaging are often just as important as the material itself. SOSCleanroom does not compromise on glove quality for critical environments; we stock best-in-class lines so customers can reduce process variability and maintain confidence in their contamination control strategy.

Third-party industry coverage has also recognized SOS Cleanroom Supply as an Ansell authorized distributor (Cleanroom Technology, published June 20, 2023). This supports continuity of supply and documentation discipline for customers who treat gloves as a controlled input, not a commodity.

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 TouchNTuff® 83-500 Sterile Polyisoprene Cleanroom Gloves — Class 100 / ISO 5, Latex-Free Comfort for Double-Donning
Class 100 / ISO 5 EU GMP Grade A Sterile (SAL 10-6) Polyisoprene Latex-Free, Powder-Free AQL 0.65 200 Pairs / Carton
1. Practical solutions in a critical environment

In ISO 5 work, gloves are a primary contamination-control surface and a frequent touch interface with components, tools, sterile transfer items, and product-contact-adjacent surfaces. TouchNTuff® 83-500 is selected when teams want latex-like tactility and comfort for long wear time, but need to avoid natural rubber latex proteins in the cleanroom program.

This glove is commonly used for double-donning strategies where the outer glove is treated as the active work layer and changed by defined triggers. Comfort matters because fatigue and "rushing" are repeat causes of technique breakdown in ISO 5 workflows.

2. What this glove is for
  • ISO 5 / Grade A aseptic and critical-zone workflows where sterile gloves are required
  • Precision handling where "feel" and dexterity reduce rework and touch-risk events
  • Programs that restrict natural rubber latex proteins due to allergy and sensitization risk
  • Validated glove change-out models (single or double-donning) with defined sanitization steps
3. Selection rationale
  • ISO 5 positioning: Tested for compatibility with Class 100 (ISO 5) / EU GMP Grade A cleanroom environments.
  • Latex-free tactility: Polyisoprene delivers a natural-rubber-like feel without natural rubber latex proteins.
  • Double-donning comfort: Thicker target single-wall construction supports durability while prioritizing comfort for prolonged wear.
  • Leak control baseline: AQL 0.65 supports sterile decision sets where pinhole risk must be managed.
  • Controlled interior donning: Polymer-coated interior supports smoother donning.
  • Cleanliness metrics: Published particle baseline supports qualification files and trending expectations.
SOSCleanroom selection philosophy
SOSCleanroom supports customers who need dependable, best-in-class cleanroom consumables. In critical environments, we do not recommend "good enough" substitutes when process risk, product integrity, and compliance expectations are on the line.
4. Materials and construction
  • Material: PI (Polyisoprene)
  • Color: White
  • Shape: Anatomic with curved fingers
  • Cuff: Beaded with SUREFIT™ Technology
  • External surface: Smooth
  • Internal surface: Polymer coated with DERMASHIELD™ Technology
  • Powder content: Powder-free
5. Specifications in context
Specification Value Operational meaning
Cleanroom classClass 100 / ISO 5 & EU GMP Grade AIntended for critical-zone and aseptic applications where glove contribution must be controlled.
SterilitySAL 10-6 (Gamma irradiation, 25 kGy)Supports sterile workflow intent when packaging presentation and donning steps are controlled.
Freedom from holes0.65 AQLBaseline leak control; any suspected defect or touch-risk event becomes an immediate change-out trigger.
Length300 mm / 12 inSupports gown-to-glove overlap and reduces exposed interface risk during reaching and rotations.
Thickness targetsPalm 0.21 mm (8.26 mil) | Finger 0.23 mm (9.05 mil) | Cuff 0.17 mm (6.69 mil)Balances comfort and durability for prolonged wear and double-donning models.
Tensile (before aging)≥ 17 MPaDurability indicator; supports controlled donning and reduces tear risk during repetitive tasks.
Force at break (before aging)9 NUseful for comparing platforms; technique and change-out discipline still dominate outcomes.
Tested for chemotherapy drugsYesSupports hazardous-drug planning; validate your specific drug list, concentration, contact time, and task mechanics.
Anti-staticNot testedDo not assume ESD performance; use an ESD-qualified glove when required by your program.
Country of originMalaysiaRelevant for supplier qualification files and site documentation requirements.
Shelf life5 yearsUse FEFO rotation; confirm lot/expiry at point of use per SOP.
6. Cleanliness metrics
Metric Value Method / reference
Typical particle count ≥ 0.5 µm≤ 2500 counts/cm2IEST-RP-CC005.4
Freedom from holes0.65 AQLEN 455-1 / ASTM D3577

Cleanliness note: Most avoidable ISO 5 glove-related excursions come from technique rather than "glove quality." Standardize how gloves are staged, opened, and donned.

7. Packaging, sterility, and traceability
  • Case configuration: 1 pair per inner polybag; 10 pairs per outer polybag; 5 polybags per master polybag; 4 master polybags per carton; 200 pairs per carton
  • Sterilization method: Gamma irradiation (25 kGy)
  • Available sizes: 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0
  • Shelf life: 5 years (store cool/dry; keep out of direct sunlight; keep away from ozone/ignition sources)
8. Best-practice use
Customer SOP disclaimer
This guidance is provided as a suggested starting point for customer SOP development and operator training. Customers must evaluate risk, validate procedures, and obtain appropriate QA/ES approval before implementation.
  • Stage with intent: Treat glove packaging as a controlled transfer item. Define where it is wiped, how it enters ISO 5, and where it is opened.
  • Donning without particle events: Open packaging slowly, minimize re-gripping, and avoid cuff snapping.
  • Sanitization (facility-defined): Use sterile alcohol; define application volume, drying expectations, and reapplication triggers.
  • Double-donning: Define inner/outer glove roles and step-based change-out rules.
  • Change-out triggers: Any tear/puncture, visible residue, tackiness, loss of grip, or contact with non-qualified surfaces is an immediate change-out event.
Suggested pairings
Use case Recommended item Why it pairs well
ISO 5 critical wipe-downsTexwipe TX3224 Sterile TexTra10™ 9" x 9"Sterile sealed-border polyester with low lint and controlled extractables.
Film-sensitive surfacesTexwipe TX3211 SterileWipe™ LP 9" x 9"Sterile continuous-filament polyester for very low particle generation.
Detail cleaning (ports, corners)Texwipe STX763 Sterile Polyester SwabSterile swab for tight geometries where wipers cannot maintain contact.
Sterile IPA sprayTexwipe TX8270 Sterile 70% IPA (8 oz.)Ready-to-use format standardizes application volume for routine sanitization.
Sterile IPA bulkTexwipe TX3290 Sterile 70% IPA (1 Gallon, 4/Case)Bulk sterile IPA for high-use points.
9. Common failure modes
  • Grip loss after sanitization: Control spray volume and allow defined dry time per SOP.
  • Latex-free ≠ "universal": Validate compatibility with chemicals, disinfectants, and task mechanics.
  • Technique-driven particle events: Fast opening, cuff snapping, and repeated re-gripping drives avoidable particulate and touch-risk events.
  • Extended use beyond triggers: Comfort can lead operators to "stretch" glove life. Change-out discipline must be explicit and enforced.
  • Assuming ESD performance: Anti-static not tested; do not use where ESD control is required without an ESD-qualified alternative.
10. Other gloves to consider
11. Program fit for regulated cleanrooms
  • Sterile ISO 5 operations: Strong fit where glove comfort, sterile presentation, and defined change-out triggers are part of the contamination control strategy.
  • Latex-protein avoidance: Appropriate for facilities restricting natural rubber latex proteins.
  • USP <797> aseptic technique programs: Aligns when integrated with facility training and validated sanitization/change rules.
  • Hazardous drug context (USP <800> planning): Site must validate specific drug list, contact time, and task mechanics before adoption.
12. Source basis
Product documentation
Standards & guidance references
These references are included to support terminology and program alignment. Customers should confirm applicability to their processes and approved SOPs.
Technical Vault Notice
Important disclaimer: This entry is provided for general process support and reference only. It is not regulatory, legal, medical, or validation advice.
Customers must evaluate risk, confirm applicability to their processes, and follow their approved SOPs, QA requirements, and the manufacturer’s instructions for use.
Questions or documentation requests: Sales@SOSsupply.com  |  (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: May 1, 2026
© 2026 SOSCleanroom.com