ISO 11193-1-2020 PDF

Full title and description

Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution. This International Standard specifies performance, dimensional and inspection requirements for packaged sterile or bulked non-sterile rubber examination gloves intended to protect patient and user from cross-contamination; it covers gloves with smooth or textured surfaces and gives requirements for sampling, testing, packaging and marking.

Abstract

ISO 11193-1:2020 defines classification, materials, dimensional limits, water‑tightness (freedom from holes), tensile properties (before and after accelerated ageing), sampling and acceptance criteria (AQLs), and marking/packaging requirements for single‑use rubber examination gloves. It is intended as a performance and safety reference for manufacturers, test laboratories and procurers and does not address clinical use or sterilization procedures.

General information

• Status: Published (International Standard, under regular review).
• Publication date: August 2020 (2020-08).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.140 (Hospital equipment); 83.140.99 (Other rubber and plastics products).
• Edition / version: Edition 3 (ISO 11193-1:2020).
• Number of pages: 10 (official ISO bibliographic entry).

Scope

Specifies requirements for packaged sterile or bulked non‑sterile rubber medical examination gloves made from natural rubber latex or rubber solutions. Applies to gloves intended for medical examinations, diagnostic or therapeutic procedures and for handling contaminated medical materials. Excludes clinical instructions for use, sterilization procedures and storage/handling guidance. The standard provides definitions, classification by type and finish, materials requirements, test sampling and acceptance criteria, performance tests (watertightness, tensile strength and elongation, ageing), and packaging and marking rules.

Key topics and requirements

• Classification: Types (rubber latex or rubber solution) and finishes (smooth, textured, powdered or powder‑free) and associated labelling requirements.
• Materials: Requirements for compounded rubber materials and compatibility/biocompatibility considerations (referencing relevant biological evaluation guidance such as ISO 10993 where applicable).
• Dimensions and thickness: Defined measurement points for palm width, finger and palm thickness and overall glove length; minimum single‑wall thicknesses specified for smooth and textured areas.
• Watertightness (freedom from holes): Normative watertightness test method (annex) and sampling/acceptance procedures; watertightness AQL and sampling plans are specified.
• Tensile properties and ageing: Force at break and elongation tested per applicable test methods, reported before and after accelerated ageing to verify retained mechanical performance.
• Sampling, inspection and AQLs: Use of statistically based sampling schemes (e.g., ISO 2859-style sampling) with defined AQLs for dimensions, tensile properties and watertightness.
• Sterility, packaging and marking: Distinct requirements for sterile vs non‑sterile packaging, unit and multi‑unit marking, batch identification and information to be supplied with the product.

Typical use and users

Used by glove manufacturers for product specifications and quality control, testing laboratories for type‑approval and conformity testing, procurement and supply chain teams for purchase specifications, and regulatory bodies or notified bodies as part of conformity assessment for medical device regulatory submissions. Hospitals and clinical providers rely on these specifications indirectly through procurement and supplier declarations.

Related standards

ISO 11193 is a multi‑part series; the closely related part is ISO 11193-2 (specification for gloves made from poly(vinyl chloride)). Other related standards and test methods referenced or commonly used alongside ISO 11193-1 include ISO 10282 (single‑use sterile surgical rubber gloves), ISO 21171 (determination of removable surface powder), and regional/sectoral standards such as EN/ISO protective glove standards and relevant parts of the EN 455 series.

Keywords

medical examination gloves, single‑use gloves, rubber latex, rubber solution, watertightness, freedom from holes, AQL, tensile properties, accelerated ageing, packaging, labelling, ISO 11193, glove specification.

FAQ

Q: What is this standard?

A: ISO 11193-1:2020 is an ISO international standard that specifies performance, dimensional, testing and inspection requirements for single‑use rubber (latex or rubber solution) medical examination gloves.

Q: What does it cover?

A: It covers classification, materials, dimensions, minimum thickness, watertightness (freedom from holes), tensile properties before and after accelerated ageing, sampling and AQLs, and packaging/marking for sterile and non‑sterile packaged gloves. It does not cover clinical use instructions, sterilization procedures or storage practices.

Q: Who typically uses it?

A: Manufacturers, raw‑material suppliers, quality and regulatory teams, testing laboratories, procurement specialists and regulatory authorities use the standard to specify, test and assess conformity of medical examination gloves.

Q: Is it current or superseded?

A: ISO 11193-1:2020 is the current published edition (third edition, published August 2020). The ISO entry indicates the standard is subject to periodic review and related DIS work items for other parts of the series may be under development. Users should confirm the edition and any amendments or drafts with the national ISO member body before relying on the standard for compliance work.

Q: Is it part of a series?

A: Yes. ISO 11193 is a multipart series addressing single‑use medical examination gloves; Part 1 covers rubber latex/rubber solution gloves and Part 2 covers PVC gloves (and other parts/related standards address surgical gloves and specific test methods).

Q: What are the key keywords?

A: Medical examination gloves; single‑use; rubber latex; rubber solution; watertightness; AQL; tensile strength; packaging; marking; ISO 11193-1:2020.