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 (CCS): 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 CCS.

• Built for ISO 5 / Class 100 / Grade A use: Published cleanroom compatibility with 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: A unique neoprene formulation is positioned for durability and puncture resistance, with chemical splash resistance for routine hazards.
• Extended, straight cuff with SUREFIT™ Technology: Aimed at reducing cuff roll-down and improving stability at the gown-sleeve interface.
• Quality indicator for integrity: Freedom-from-holes AQL 0.65 supports an audit-friendly incoming quality discussion.
• Documentable sterilization method: Gamma irradiation (25 kGy) with defined packaging configuration supports validation and training consistency.

• Material: Neoprene (polychloroprene).
• Color: Green (high visibility supports inspection and glove-change discipline).
• Shape: Anatomic with curved fingers (supports 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 are built for 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 published 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 CCS.

• Case configuration (published): 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 (published): Gamma irradiation (25 kGy).
• Available sizes (published): 6.0, 6.5, 7.0 (S), 7.5, 8.0, 8.5, 9.0.
• Shelf life (published): 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 straight cuff smoothly and confirm overlap at the sleeve interface. Re-check after interventions that involve reach or rotation.
• Sanitization (program-defined): If your CCS uses sterile IPA wipes/sprays for glove sanitization during work, validate compatibility and 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 CCS).

• 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 CCS.

• 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 (validate 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: Published ASTM D6978 testing note supports evaluation conversations (confirm drug list and facility policy requirements).
• CCS-driven operations: 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. SOSCleanroom focuses on fast shipping, excellent customer service, fair pricing, and continuity of supply for critical environments.

If you are qualifying this glove for ISO 5 / critical-zone use, keep the focus on the full system, not the glove alone. Document where gloves are opened, how they are transferred to point-of-use, what sanitization steps are used (if any), and what intervention-based change-out rules are enforced.

• Incoming inspection: Verify packaging integrity, correct size, and labeling; define quarantine rules for compromised packs.
• Operator training: Teach cuff seating, sleeve overlap checks, and “no snap” donning behavior to prevent particle events.
• Validation tie-in: If your process requires extractables/endotoxin/SAL documentation, request a formal quality packet through your approved supplier channel and reference it in your CCS.
• Standards context: Published references include IEST-RP-CC005.4 (particle count) and EN/ASTM glove test methods, with broader quality and regulatory standards listed in the manufacturer data sheet.