ISO 11193-1:2020

Overview

ISO 11193-1:2020 - Single-use medical examination gloves (Part 1) specifies performance and safety requirements for single-use medical examination gloves made from rubber latex or rubber solution. The standard covers packaged sterile gloves and bulked non-sterile gloves intended to protect patients and users from cross-contamination during diagnostic, therapeutic and handling of contaminated medical materials. It is a reference standard for manufacturers, test laboratories and procurement teams and does not address clinical use, sterilization procedures or storage practices.

Key Topics and Requirements

• Scope and classification
  • Applies to gloves made from natural rubber latex (Type 1) and other rubber solutions (Type 2: nitrile, polychloroprene, SBR, thermoplastic-elastomer).
  • Surface finishes: textured, smooth, powdered (max 10 mg/glove) and powder-free (max 2.0 mg residue/glove).
• Materials
  • Compounded rubber materials; pigments and surface treatments must be biocompatible and meet ISO 10993 requirements.
• Dimensions and thickness
  • Defined measurement points for palm width and glove length (length = tip of middle finger to cuff).
  • Minimum single-wall thickness: smooth area ≥ 0.08 mm, textured area ≥ 0.11 mm.
• Mechanical and ageing performance
  • Tensile properties (force at break and elongation) measured per ISO 37, reported before and after accelerated ageing (ISO 188).
• Watertightness
  • Leakage testing method given in Annex A; acceptance sampling uses ISO 2859-1 sampling schemes with specified AQLs.
• Sampling, inspection and AQLs
  • Physical dimensions and tensile properties: AQL 4.0; water tightness: AQL 2.5.
• Packaging and marking
  • Requirements for unit and multi-unit packaging and labeling, with separate provisions for sterile and non-sterile packs.

Applications

• Ensures product safety, performance and regulatory compliance for single-use rubber examination gloves.
• Used for:
  • Product design and quality control by glove manufacturers.
  • Type testing and lot-release inspection by laboratories.
  • Procurement specifications for hospitals, clinics and distributors.
  • Regulatory assessment and conformity documentation.

Who should use this standard

• Medical glove manufacturers and R&D teams
• Quality assurance and compliance managers
• Test laboratories performing physical, watertightness and ageing tests
• Hospital procurement and infection control specialists
• Regulatory bodies evaluating medical glove safety

Related Standards

• ISO 10993 (biological evaluation of medical devices)
• ISO 37 (tensile stress–strain properties)
• ISO 188 (accelerated ageing)
• ISO 23529 (preparing test pieces)
• ISO 2859-1 (sampling by attributes)

ISO 11193-1:2020 is essential when specifying, testing or procuring single-use medical examination gloves made from rubber latex or rubber solutions to ensure consistent safety and performance.