ISO 10282:2023

Overview

ISO 10282:2023 - Single-use sterile rubber surgical gloves - Specification - defines performance and safety requirements for packaged sterile surgical rubber gloves intended for single use in surgical procedures. It covers glove classification by material, design and finish, measurement and sampling rules, mechanical and leakage performance, sterility and biocompatibility expectations, and marking/packaging requirements. (It does not apply to examination/procedure gloves or to use/sterilization/handling procedures.)

Key topics and technical requirements

• Materials & biocompatibility
  • Two material types: Type 1 (natural rubber latex) and Type 2 (nitrile, isoprene, polychloroprene, SBR, thermoplastic elastomer solutions).
  • Manufacturers must demonstrate compliance with the ISO 10993 biological evaluation series.
• Classification & finishes
  • Design: straight or palmar-curved fingers; cuff: cut or rolled rim.
  • Finishes: textured, smooth, powdered, and powder-free (powder-free residue limit specified in the standard).
• Dimensions
  • Sizes are specified with nominal widths and lengths (e.g., size code 7 = 89 ± 5 mm width, 270 mm minimum length). Single-wall thickness limits differ by finish (smooth vs textured).
  • Dimensional measurement method provided in Annex A.
• Watertightness
  • Leak testing method is normative (Annex B); sampling and acceptance based on ISO 2859-1 sampling plans with defined AQLs.
• Tensile / mechanical properties
  • Tensile testing follows ISO 37 with requirements for force at break, elongation at break, and force at 300% elongation both before and after accelerated ageing (accelerated ageing per ISO 188).
  • Example values: minimum elongation before ageing - 700% (Type 1) and 600% (Type 2); minimum force at break before ageing - 12.5 N (Type 1) and 9.0 N (Type 2).
• Sampling & acceptance
  • Sampling by ISO 2859-1 with specified inspection levels and AQLs for dimensions, watertightness and tensile properties.
• Packaging & marking
  • Requirements for inner/unit/multi-unit package marking and sterility declaration are included.

Applications and users

ISO 10282:2023 is used by:

• Glove manufacturers for product design, production control and compliance.
• Quality and regulatory teams for certification, CE/market access and supplier qualification.
• Testing laboratories for acceptance testing (dimensions, watertightness, tensile, ageing).
• Procurement and clinical engineering to specify supplier and product requirements for sterile single-use surgical gloves.

Related standards

• ISO 37 (tensile testing), ISO 188 (accelerated ageing), ISO 2859-1 (sampling), ISO 10993 (biocompatibility), and ISO 21171 (powder measurement) - all referenced by ISO 10282:2023.

For full test methods, limits and tables, consult ISO 10282:2023 and the referenced normative documents.