ISO 25518:2021

Overview

ISO 25518:2021 specifies requirements, sampling and test methods for single‑use rubber gloves for general applications (not for medical use). It covers gloves made from natural rubber latex, synthetic rubber latex or rubber solution and defines physical requirements, tensile performance, watertightness testing, sampling plans and labelling information. The standard does not address safe or proper use of gloves.

Key topics and technical requirements

• Materials and disclosures
  • Gloves must be made from suitable, non‑toxic materials; pigments, lubricants and surface treatments must be disclosed on request.
• Dimensions
  • Sizes from XS to XL are defined by palm width (W) and minimum length (L). Example ranges: XS ≤ 80 mm width, S 80 ±10 mm, M 95 ±10 mm, L 110 ±10 mm, XL ≥110 mm; minimum lengths typically 220–230 mm. Measurements follow the standard’s specified points and mandrel method.
• Watertightness
  • Annex A describes a watertightness procedure using a hollow mandrel and 1 000 cm³ water (observe for leaks immediately and after 2–4 min; disregard leakage within 40 mm of the cuff).
• Tensile properties and ageing
  • Tensile testing uses ISO 37 (type 2 dumb‑bell pieces); results use median of three specimens taken from palm/back.
  • Minimums: force at break and elongation before and after accelerated ageing are specified; accelerated ageing follows ISO 188 (e.g., 70 °C for 168 h or 100 °C for 22 h).
• Sampling and inspection
  • Lot inspection follows ISO 2859‑1. The standard sets inspection levels and AQLs (e.g., dimensions S‑2 AQL 6.5; watertightness S‑4 AQL 4.0; tensile S‑2 AQL 6.5).
• Labelling
  • Required markings: manufacturer/trademark, material, textured/smooth and powdered/powder‑free status (powder‑free residue limit specified), size, lot number, date of manufacture (YYYY-MM), approximate quantity, storage instructions and the words “NOT FOR MEDICAL OR INDUSTRIAL USE” (or equivalent).

Applications and users

ISO 25518:2021 is practical for:

• Glove manufacturers - product design, in‑line QC, product specifications and batch release.
• Testing and QC laboratories - test methods for tensile, watertightness and accelerated ageing.
• Procurement and specification writers - purchase specifications for non‑medical single‑use rubber gloves.
• Regulatory bodies and auditors - conformity checks and labelling verification.
• Suppliers and distributors - packaging and marking compliance.

Keywords: ISO 25518:2021, single‑use rubber gloves, specification, watertightness test, tensile properties, accelerated ageing, sampling AQL, glove labelling, powder‑free gloves.

Related standards

• ISO 37 - Rubber - Determination of tensile stress‑strain properties
• ISO 188 - Rubber - Accelerated ageing and heat resistance tests
• ISO 2859‑1 - Sampling procedures for inspection by attributes (AQL)