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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)

$565.70
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SKU:
83-500
Availability:
7 - 10 Business Days
Shipping:
Calculated at Checkout
Quantity Option (Case):
200 Pairs
Inner Packaging:
See Below
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
Sterile Polyisoprene Class 100 / ISO 5 EU GMP Grade A (tested) Gamma sterilized (SAL 10-6)
TouchNTuff® 83-500 Sterile Polyisoprene Cleanroom Gloves — “Second-skin” tactility for ISO 5 aseptic handling and double-gloving workflows
Ansell TouchNTuff 83-500 sterile polyisoprene cleanroom gloves
Product image (representative)
1) Practical solutions in a critical environment
In ISO Class 5 (Class 100) work, gloves are the most frequent contact surface in the process. The wrong glove can become a particle source, a sterility risk, a fatigue driver, or a chemical-compatibility failure. TouchNTuff® 83-500 is designed for sterile, residue-sensitive handling where you need latex-like dexterity without natural rubber latex proteins, and where consistent glove change discipline supports a contamination control strategy (CCS) under U.S. cGMP expectations and global benchmarks such as EU GMP Annex 1.
2) What it’s for
TouchNTuff® 83-500 is a sterile, powder-free polyisoprene glove tested for Class 100 (ISO 5) / EU GMP Grade A cleanroom compatibility. It is commonly selected for aseptic manipulations and critical handling steps where operators need fine motor control, sustained comfort, and predictable cleanliness performance.
  • ISO 5 aseptic handling: transfers, manipulations, and interventions where sterility at point-of-use matters
  • Biotech and pharmaceutical unit operations: sampling, material prep, labeling/packaging, and process handling
  • Medical device manufacturing and inspection where tactile control reduces slips, drops, and rework
  • Double-gloving programs (outer glove or underglove) when change frequency is part of the CCS
3) Why should customers consider this glove
  • ISO 5 / Grade A cleanroom tested: Designed and tested for compatibility with Class 100 (ISO 5) / EU GMP Grade A environments.
  • Latex-protein-free risk reduction: Polyisoprene performance without natural rubber latex proteins (supports Type I latex allergy avoidance programs).
  • Sterile by gamma irradiation: Sterilized and validated to a sterility assurance level (SAL) of 10-6.
  • Comfort for long wear and double gloving: “Second skin” feel helps reduce fatigue and supports controlled touch in critical steps.
  • DERMASHIELD™ internal coating: Polymer-coated interior supports donning consistency (especially relevant in sterile gowning workflows).
  • Quality screening baseline: 0.65 AQL (freedom from holes) as a published acceptance level.
  • Published particle baseline: Typical particle count reported for ≥0.5 µm to support contamination-risk discussions and glove-change logic.
  • Documented packaging configuration: Pair-packed sterile presentation supports controlled transfer and point-of-use practices.
4) Materials and construction
TouchNTuff® 83-500 is made from PI (polyisoprene) with a smooth external surface and an internal polymer coating identified by Ansell as DERMASHIELD™. The glove is anatomically shaped with curved fingers for reduced hand stress over longer wear. The cuff is beaded and uses SUREFIT™ technology to support secure placement and consistent overlap with gown sleeves.
5) Specifications in context
For ISO 5 operations, “specs” are not shopping details — they are levers that affect intervention risk, operator fatigue, and the probability that gloves become the dominant contamination source. Use the table below to align the glove to your CCS, change frequency, and the real mechanical demands of the task.
Specification Published value Why it matters in use
Cleanroom class Class 100 / ISO 5 & EU GMP Grade A (tested) Directly aligns to aseptic/critical zone expectations where gloved-hands are a primary risk vector.
Sterility Sterile; gamma irradiation (25 kGy noted in TDS); SAL 10-6 Supports sterile transfer and point-of-use practices; SAL is a common comparator in sterile consumables.
Freedom from holes 0.65 AQL (Inspection Level I) AQL is a practical screening baseline; still requires real-world inspection and change discipline.
Length 300 mm / 12 in Supports sleeve overlap and reduces exposed skin risk during reaches, turns, and interventions.
Thickness (single wall) Palm 0.21 mm (8.26 mil); Finger 0.23 mm (9.05 mil); Cuff 0.17 mm (6.69 mil) Balances tactile control vs. durability; thicker is not always “safer” if it increases fatigue and drops.
Cuff style Beaded with SUREFIT™ technology; standard cuff Helps keep the glove seated during repeated motions and reduces “roll-down” events.
Interior coating Polymer coated with DERMASHIELD™ technology Supports smoother donning and consistent fit during sterile gowning and changes.
Chemotherapy drug testing Yes (published) Relevant for hazardous drug workflows; always validate against your facility’s drug list and dwell-time expectations.
Country of origin Malaysia Useful for procurement documentation and risk assessments; do not assume interchangeability across factories.
Shelf life 5 years (published) Supports inventory planning, controlled storage, and CCS documentation.
Available sizes 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 Correct sizing reduces finger stress (tears) and improves dexterity and consistent touch pressure.
6) Cleanliness metrics
These published baselines help teams discuss glove-change frequency, intervention risk, and whether glove contact is likely to dominate particle background during critical handling.
Metric Typical / published value Test method / note
Particle count (≥0.5 µm) ≤ 2500 counts/cm² IEST-RP-CC005.4 (as listed in the technical data sheet)
Freedom from holes 0.65 AQL EN 455-1 / ASTM D3577 referenced in the technical data sheet
Ionic / NVR / endotoxin Not published on the linked product page or the posted TDS If your process is residue-limited, request lot documentation (CoA/CoC) and validate with your method
Note: “Cleanroom compatible” is not the same as “fits every ISO 5 process.” The cleanest glove still becomes a risk if gowning, changes, and sanitization are inconsistent.
7) Packaging, sterility, and traceability
  • Pack configuration (published): 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 (published): Gamma irradiation (25 kGy noted in the technical data sheet). Sterility is validated to SAL 10-6.
  • Storage (published): Keep out of direct sunlight; store in a cool, dry place; keep away from ozone/ignition sources.
  • Traceability: Lot coding/lot-level documentation is not explicitly stated on the posted TDS. For CCS documentation, request lot-specific paperwork (certificate of conformance/compliance as applicable) through SOSCleanroom.
  • Declarations of conformity: EU and UK declarations of conformity are available on the SOSCleanroom product page for documentation support.
EU GMP Annex 1 alignment note (customer education)
Annex 1 treats gloves as a core contamination control element during aseptic processing. The practical takeaway is not “buy a glove and you are compliant” — it is to treat gloves as part of the CCS: validated gowning, defined change frequency (including after interventions), controlled sanitization of outer gloves (when applicable), and documented transfer practices for sterile packs into Grade A/ISO 5 zones.
8) Best-practice use
Use these operator-level practices to keep the glove from becoming the dominant contamination variable.
  • Size for control, not comfort alone: Too small increases stress at the finger webbing and raises tear risk; too large increases slip and pinch errors.
  • Donning discipline: Use the inner polybag presentation as your “clean boundary.” Avoid contacting the exterior surface during donning; if you do, change immediately.
  • Double-gloving logic: If you double glove, define which layer is “sacrificial” (outer) and change it on a timer and after interventions. Treat “I’m careful” as noncompliant language in the CCS.
  • Sleeve overlap check: With 12-inch gloves, confirm consistent overlap under the gown cuff; re-check after repeated reaches or high-friction tasks.
  • Sanitization practices: If your process uses sterile alcohol on gloves, validate contact time and compatibility. Excessive wetting can change tactility and can transfer solvent to sensitive surfaces.
  • Hazardous drug workflows: “Tested for use with chemotherapy drugs” is a decision input, not a blanket approval for every drug and dwell time. Match the glove to your drug list and your facility’s hazardous drug program requirements.
Customer SOP disclaimer
The guidance above is provided as a practical starting point for customers building or refining internal procedures. It is not a substitute for your site’s approved SOPs, validation package, or quality system requirements. Customers should perform their own risk assessment, training, and qualification (including material compatibility and disinfectant contact time) before adopting any process change in a controlled environment.
9) Common failure modes
  • Pinholes and micro-tears: Often caused by over-stretching (wrong size), sharp edges on fixtures, or aggressive tool handling.
  • Roll-down and sleeve gap events: A cuff that shifts during repeated reaches can expose skin or gown interfaces; verify overlap during work, not only at gowning.
  • Process solvent mismatch: Polyisoprene is chosen for tactility and comfort; it may not be the best choice for every solvent. Validate chemical exposure scenarios.
  • Over-sanitization drift: Excessive alcohol wetting can change grip and increase slip/drops, especially during repetitive manipulations.
  • False confidence in “sterile”: Sterility is point-of-use dependent. A sterile glove handled or transferred incorrectly becomes a contamination source immediately.
10) Closest competitors
In ISO 5 sterile glove selection, customers typically cross-shop by material family (polyisoprene vs. nitrile vs. neoprene vs. latex) and by the documentation package available for audits.
  • Sterile nitrile (ISO 5): Often favored for broader chemical resistance; can feel stiffer than polyisoprene in fine manipulations.
  • Sterile neoprene (ISO 5): Frequently selected for splash resistance and accelerator-free needs; may trade off some “second-skin” feel.
  • Sterile latex (ISO 5): High tactility, but introduces natural rubber latex protein considerations in many facilities.
11) Program fit
TouchNTuff® 83-500 fits programs that run ISO 5 aseptic handling and want a latex-like feel without natural rubber latex proteins — particularly where operator fatigue, fine motor control, and double-gloving discipline are part of the CCS. In the U.S., align glove selection and change practices with your contamination control approach under FDA cGMP expectations and applicable compounding standards (USP <797> / USP <800> where relevant). For global benchmarking and continuous improvement, EU GMP Annex 1 is commonly used as a reference framework for CCS thinking and sterile intervention discipline.
Complementary ISO 5 contamination-control consumables (matched environment)
Many ISO 5 programs standardize sterile gloves alongside sterile wiping systems to reduce variability during interventions and line-side cleaning.
  • ITW Texwipe sterile cleanroom wipers (ISO 5 capable): Example: Texwipe TX3224 Sterile TexTra10 9" x 9" wiper (ISO classes listed include ISO 5 on the SOSCleanroom page).
  • ITW Texwipe sterile IPA systems: Pair sterile wiping with validated disinfectant strategy per your CCS (including rotation/sporicidal use where applicable).
SOSCleanroom is the authorized Master Distributor of ITW Texwipe for the United States market, and for over 35 years, SOS and Texwipe have been close partners — a practical advantage when customers need continuity of supply and documentation discipline for critical environments.
12) Source basis
Primary product references
  • SOSCleanroom product page (specs, packaging, downloads): https://www.soscleanroom.com/product/brands/ansell-83-500-touchntuff-sterile-polyisoprene-gloves-class-100-iso-5/
  • Ansell product page (TouchNTuff® 83-500 overview and downloads): https://www.ansell.com/us/en/products/touchntuff-83-500
  • SOS-hosted Product Data Sheet PDF (stable reference copy): https://www.soscleanroom.com/content/Ansell_PDF/touchntuff-83-500_pds_us.pdf
  • Ansell PDS page (manufacturer-hosted data sheet landing): https://www.ansell.com/us/en/products/touchntuff-83-500/pds/bNilhptzaQGaBfP3whv0g
  • EU Declaration of Conformity (SOS-hosted PDF): https://www.soscleanroom.com/content/Ansell_PDF/touchntuff-83-500_touchntuff%C2%AE-83-500_eu_20230511_declaration%20of%20conformity.pdf
  • UK Declaration of Conformity (SOS-hosted PDF): https://www.soscleanroom.com/content/Ansell_PDF/touchntuff-83-500_touchntuff%C2%AE-83-500_uk_20230511_declaration%20of%20conformity.pdf
Third-party validation and program context
  • Cleanroom Technology (June 20, 2023) distributor validation: https://cleanroomtechnology.com/sos-cleanroom-supply-becomes-ansell-authorised-distributor-209576
  • FDA (cGMP baseline reference): https://www.fda.gov
  • ISO (ISO 14644 terminology and controlled-environment framing): https://www.iso.org/standard/53394.html
  • ASTM (test methods and material performance references): https://www.astm.org
  • IEST (contamination control and test practice references): https://www.iest.org
  • EU GMP Annex 1 (global benchmark for sterile manufacture): https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
Matched-environment companion product reference (ISO 5 capable)
  • Texwipe TX3224 sterile wiper page (ISO classes listed include ISO 5): https://www.soscleanroom.com/product/wipers/texwipe-tx3224-sterile-textra10-9-x-9-polyester-cleanroom-wiper/
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: Jan. 10, 2026
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