ISO 11193-2:2006 is an ISO specification for single-use medical examination gloves made from poly(vinyl chloride) (PVC). It is used by glove manufacturers, private-label brands, and healthcare supply chains to define baseline performance and safety requirements for PVC exam gloves.
If you need help aligning your incoming inspection or supplier qualification plan to the exact edition being cited, talk with our team about your product type and documentation package.
ISO 11193-2:2006 — Single-use medical examination gloves — Part 2: Specification for gloves made from poly(vinyl chloride)
ISO 11193-2:2006 defines requirements for packaged sterile, or bulked non-sterile, PVC medical examination gloves intended for medical examinations and diagnostic or therapeutic procedures, with the goal of reducing cross-contamination risk.
It also addresses PVC examination gloves intended for handling contaminated medical materials. Activities such as clinical glove-use practices and sterilization/handling processes are not covered by this document.
Quick Definition
Document type: Specification (requirements-focused standard for a finished medical glove product).
What it covers: Performance and safety requirements for single-use medical examination gloves made from PVC, including expectations appropriate for sterile packaged gloves or non-sterile bulked gloves.
What it does not cover: Clinical guidance on glove use, and sterilization procedures and subsequent handling/packaging/storage practices.
What This Standard Covers
ISO 11193-2:2006 is used to define what a PVC examination glove must meet to be considered suitable as a single-use medical exam glove, including use cases where the glove functions as a barrier to help protect patient and user from cross-contamination.
In practice, organizations use the specification to set supplier requirements, confirm product claims, and structure verification testing and documentation for PVC exam gloves (sterile or non-sterile).
Why This Standard Matters in Testing
PVC exam gloves are frequently purchased in high volumes, so buyers often rely on standardized specifications to reduce variability across lots and suppliers. ISO 11193-2 provides a recognized baseline for what “medical examination glove” performance should mean for PVC products.
For QA/QC teams, this standard is commonly used to support incoming inspection criteria, periodic requalification, and supplier scorecards where consistent physical performance and barrier expectations are critical.
Common Materials, Product Types, or Applications Covered
Material: Poly(vinyl chloride) (PVC).
Product type: Single-use medical examination gloves supplied as packaged sterile gloves or bulked non-sterile gloves.
Typical use environments: Medical examinations, diagnostic/therapeutic procedures, and handling contaminated medical materials where a disposable barrier glove is required.
Common Test or Verification Workflow
Because ISO 11193-2 is a product specification, it is most often implemented as a verification program rather than a single bench test. Many labs apply it through routine sampling and lot-based acceptance activities.
Common workflow elements: Incoming or release sampling, basic physical/property verification appropriate to the product claim, and documentation review (e.g., lot traceability and supplier declarations) tied to the exact cited edition of the standard.
Equipment Commonly Used for This Standard
Equipment selection depends on which requirement(s) you are verifying under the cited edition and on whether you are running manufacturer qualification testing, incoming inspection, or investigative failure analysis.
Common equipment families: Universal testing machines for glove mechanical property checks (when required by the cited specification), appropriate grips/fixtures for thin polymer films and glove materials, and basic dimensional measurement tools for product conformance checks.
If you are choosing a test frame capacity, grip style, or extensometry approach for thin, highly extensible glove materials, you can request a detailed quote for a configuration matched to your throughput and reporting needs.
How to Read This Designation or Revision
Designation meaning: “ISO 11193-2” indicates Part 2 of the ISO 11193 series for single-use medical examination gloves; this part is specific to gloves made from poly(vinyl chloride) (PVC).
Edition/date: The edition is identified by the year (e.g., ISO 11193-2:2006). When purchasing to a standard, qualifying suppliers, or writing test reports, the cited year matters because requirements and referenced methods can change between editions.
Status note: ISO identifies ISO 11193-2:2006 as published and indicates it has been reviewed/confirmed (most recently noted in 2016) while also showing a draft next version under development (ISO/DIS 11193-2).
Related Standards, Methods, or Frameworks when useful
ISO 11193-2 is often evaluated alongside other single-use medical glove standards when organizations are comparing material types or aligning global specifications across product lines.
Common related references: ISO 11193-1 (rubber examination gloves) and EN 455-2 (physical requirements and testing for medical gloves) are frequently referenced in the same procurement and lab-testing conversations, depending on region and glove material.
Get help selecting a practical ISO 11193-2 test setup
If you share the glove material, thickness range, and the exact standard edition your customer or regulator is citing, we can help map the requirement to a practical equipment and workflow plan—contact our team to discuss your application.