Ansell 73-701 TouchNTuff DermaShield Sterile Neoprene Gloves Class 100 (ISO 5)

In ISO 5 / Class 100 work (and EU GMP Grade A critical zones), gloves are not “just PPE.” They are part of your contamination control strategy: they affect particle release, intervention risk, and the reliability of aseptic technique. TouchNTuff® DermaShield™ 73-701 is designed for aseptic handling where you want sterile presentation, consistent barrier performance, and lower allergy potential (latex-free and accelerator-free), while maintaining practical durability for wet work and splash-prone tasks.

For U.S. operations, programs typically anchor to FDA cGMP expectations and aseptic processing discipline, with ISO 14644 terminology used to describe air cleanliness. EU GMP Annex 1 can be used as a secondary benchmark to strengthen risk-based behaviors (interventions, glove sanitization practices, material transfer, and documentation) without implying Annex 1 is a U.S. legal requirement.

• Transferring liquids and solids in aseptic workflows.
• Sample taking and processing where operator comfort and low allergy potential support staffing continuity.
• Blending and compounding solids and liquids, including wet handling where glove integrity and splash resistance matter.
• Aseptic filling and labeling steps, including interventions where glove change-out discipline is part of the contamination control program.

• Built for ISO 5 / Class 100 / Grade A use: Cleanroom compatibility supported by an established particle-count method reference.
• Lower allergy potential by design: Contains no natural rubber latex proteins and is free of chemical accelerators, reducing common Type I and Type IV sensitization drivers.
• Neoprene performance for wet handling: Neoprene is commonly selected for durability and puncture resistance, with chemical splash resistance for routine hazards.
• Extended, straight cuff with SUREFIT™ Technology: Helps reduce cuff roll-down and supports stability at the gown-sleeve interface.
• Quality indicator for integrity: Freedom-from-holes AQL 0.65 supports incoming quality discussions.
• Documentable sterilization method: Gamma irradiation with defined packaging configuration supports training and consistency.

• Material: Neoprene (polychloroprene).
• Color: Green (visibility supports inspection and glove-change discipline).
• Shape: Anatomic with curved fingers (dexterity during sustained aseptic manipulations).
• Cuff: Straight cuff with SUREFIT™ Technology; cuff length listed as extended.
• External surface: Textured fingers (grip support for wet handling and component manipulation).
• Internal surface: Polymer coated with DERMASHIELD™ Technology (donning consistency and comfort).
• Powder content: Powder-free.

The 295 mm (11.6-inch) “long” length and extended cuff specification support the gown interface — one of the most common contamination-control weak points during interventions. In ISO 5 work, operators repeatedly flex wrists, rotate forearms, and reach into equipment; any sleeve pullback or cuff roll-down increases risk. Thickness targets are set to balance tactile sensitivity with durability for wet handling: a slightly thicker palm and fingertip can reduce micro-tears during repeated pinch and pull tasks (tubing, stoppers, bag ports, and fixture edges).

Cleanliness metrics are most useful when they are tied to operator behavior and material flow. In an ISO 5 program, define where gloves are opened, how long they are exposed before donning, how they are sanitized (if applicable), and what triggers immediate glove change-out during interventions.

Not listed in available product documentation: typical ion extractables, typical NVR, endotoxin, and sterility assurance level (SAL) statement. If your validation requires these, request a formal quality packet through your approved supplier channel and document the justification in your contamination control strategy.

• Case configuration: 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 of 200 pairs per carton/case.
• Sterilization method: Gamma irradiation (25 kGy).
• Available sizes: 6.0, 6.5, 7.0 (S), 7.5, 8.0, 8.5, 9.0.
• Shelf life: 5 years (use FEFO rotation and verify packaging integrity at receiving and point-of-use).

• Stage with intent: Treat sterile glove packs as controlled materials. Keep outer packaging out of the ISO 5 field; open inner layers only at point-of-use to reduce exposure time.
• Donning without particle events: Avoid snapping gloves. Seat the cuff smoothly and confirm overlap at the sleeve interface. Re-check after interventions that involve reach or rotation.
• Sanitization (facility-defined): If your program uses sterile IPA wipes/sprays for glove sanitization during work, define frequency, dwell expectations, and reapplication triggers. If gloves become visibly compromised or suspect, change out immediately.
• Double-donning: Where risk is higher (extended interventions, frequent surface contact), define an underglove/outer-glove model with clear outer-glove change triggers.
• Change-out triggers: Any suspected breach, contact with non-controlled surfaces, tackiness, swelling, loss of fit, or after defined high-contact steps (as documented in the contamination control strategy).

• Cuff roll-down or sleeve-gap exposure: Often driven by sizing errors, rushed donning, or friction at the sleeve interface. Train to seat the cuff smoothly and re-check after high-motion interventions.
• Micro-tears from pinch and pull tasks: Repeated handling of sharp edges or rigid components can create small breaches. Use double-donning and define change-out intervals for high-risk tasks.
• Packaging integrity issues: Any puncture, moisture intrusion, or compromised seal should trigger quarantine and rejection per receiving SOP.
• Process mismatch: Using a non-antistatic glove where ESD control is required can create hidden yield or safety problems. Validate in-process behavior.
• Operator drift: Overextending a glove’s use beyond validated change triggers is a common root cause of contamination events. Put the triggers in writing and audit adherence.

These alternatives are commonly evaluated in sterile ISO 5 decision sets. Selection should be driven by allergy profile, tactile needs, and the intervention model defined in your facility procedures.

• Ansell 73-500 TouchNTuff® Sterile Neoprene (ISO 5) : Often selected when a thinner sterile neoprene glove is preferred to maximize tactile sensitivity.
• Ansell 73-711 DermaShield™ Sterile Neoprene (ISO 5) : Similar sterile neoprene family; compare cuff style and thickness targets to match your handling and comfort priorities.
• Ansell 83-500 TouchNTuff® Sterile Polyisoprene (ISO 5) : Frequently considered when teams want a latex-like feel without natural rubber latex proteins (confirm program preferences and change-out behavior).

• Life sciences aseptic workflows: Strong fit when sterile presentation, lower allergy potential, and wet-work resilience are required in ISO 5 tasks.
• Hazardous drug handling environments: ASTM D6978 testing note supports evaluation conversations (confirm drug list and facility policy requirements).
• Written and trained practices: Works best when glove staging, opening, sanitization (if used), and change-out triggers are written, trained, and audited.
• Supplier discipline: Sterile glove programs benefit from consistent documentation and dependable supply.