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 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.