ISO 11193-1 is an ISO product specification for single-use medical examination gloves made from rubber latex or rubber solution. It is commonly used by glove manufacturers, importers, and QA teams to verify that gloves meet defined performance and safety requirements before release or acceptance.
If you need help matching your glove type (latex vs. other elastomers), sterility claim, or inspection plan to the right edition and companion references, talk with our team.
ISO 11193-1:2020 — Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution
ISO 11193-1 is written to define requirements for rubber examination gloves supplied as packaged sterile or as bulk non-sterile product. It is used as a reference point for performance and safety expectations for examination gloves, while leaving clinical use practices and sterilization process controls outside its scope.
Quick Definition
ISO 11193-1 is a product specification for rubber single-use medical examination gloves that sets acceptance requirements and references standardized test methods used for inspection and verification.
What This Standard Covers
This standard focuses on glove attributes that can be inspected and measured to support product release, purchasing acceptance, and ongoing quality monitoring. In practice, it is used to control glove quality across production lots and to support labeling and product claims tied to examination glove performance.
Common requirement areas include: physical dimensions and thickness checks, barrier integrity (leak/defect screening), and rubber mechanical performance testing using referenced ISO methods.
Why This Standard Matters in Testing
For medical examination gloves, buyers and regulators expect clear evidence of barrier performance and consistent physical properties. ISO 11193-1 supports that expectation by linking glove acceptance to defined sampling/inspection approaches and repeatable lab test methods.
From a lab-management standpoint, ISO 11193-1 is typically implemented as a routine QC/QA test plan (incoming inspection, in-process verification, and/or finished-lot release) rather than as a one-time R&D characterization activity.
Common Materials, Product Types, or Applications Covered
ISO 11193-1 applies to single-use medical examination gloves made from rubber latex or rubber solution, including products supplied as sterile packaged gloves or bulk non-sterile gloves. It is commonly referenced for gloves used in medical examinations and in diagnostic or therapeutic procedures where cross-contamination control is a key concern.
When your product is not rubber-based (for example, PVC), the applicable ISO glove part may differ, so the material family and the cited part number matter.
Common Test or Verification Workflow
Most ISO 11193-1 programs are run as a lot-based verification workflow with sampling, inspection, and defined pass/fail criteria. The exact workflow depends on whether you are doing manufacturer release testing, incoming inspection, or third-party conformity evaluation.
Common workflow elements: lot definition and sampling, visual/attribute inspection, dimensional checks, leak integrity screening, mechanical property testing for rubber, and documentation suitable for procurement and quality records.
Equipment Commonly Used for This Standard
Because ISO 11193-1 is a specification that references established test methods, equipment selection usually focuses on repeatability, throughput, and traceable measurement rather than specialized one-off fixtures.
Common equipment families: leak/watertightness test stations for glove barrier screening, thickness measurement instruments appropriate for elastomer films, dimensional measurement tools (length/width), universal tensile testing machines configured for rubber test pieces, and aging/conditioning equipment when required by the referenced method set.
If you are equipping a QC lab for routine glove release testing and need to align capacity, fixtures, and reporting outputs to your inspection plan, you can request pricing for a test setup matched to your glove volume and compliance workflow.
How to Read This Designation or Revision
ISO 11193-1 identifies the standard family and Part 1 identifies the rubber-latex/rubber-solution glove specification (other parts cover other material families). When written as ISO 11193-1:2020, the four-digit year indicates the published edition year being cited.
Revision sensitivity: acceptance criteria, referenced test methods, and sampling/inspection details can change between editions, so purchase specs and test reports should cite the exact year (edition) used.
Related Standards, Methods, or Frameworks
ISO 11193-1 commonly points to other ISO documents for sampling plans, rubber mechanical testing, and medical-device biological evaluation considerations. Your internal test plan may also include additional regulatory or customer-specific requirements beyond ISO 11193-1, depending on market and labeling claims.
Commonly associated references: ISO 11193-2 (for PVC examination gloves), ISO sampling/inspection standards for attribute acceptance, ISO rubber tensile testing methods, and ISO 10993 series considerations for biological evaluation where applicable.
Talk with us about ISO 11193-1 testing capacity
Whether you are building a glove QC lab or upgrading equipment for higher throughput, we can help map ISO 11193-1 verification needs to practical instrumentation, fixtures, and documentation outputs. To compare options and lead times, ask for a detailed quote.