ISO 10282-2023 PDF

Full title and description

ISO 10282:2023 — Single-use sterile rubber surgical gloves — Specification. This International Standard (fourth edition, 2023) specifies performance and safety requirements for packaged single‑use sterile rubber surgical gloves intended to protect both patient and user during surgical procedures; it covers gloves with smooth or textured surfaces and is available as a purchasable PDF.

Abstract

This document specifies requirements for packaged sterile rubber gloves intended for use in surgical procedures to protect the patient and the user from cross‑contamination. It applies to single‑use gloves that are worn once and discarded and does not apply to examination or procedure gloves. The standard covers both smooth and partially or fully textured gloves and is intended as a reference for performance and safety; safe/proper usage, sterilization procedures, and storage/handling details are outside its scope.

General information

• Status: Published.
• Publication date: February 2023 (published 16 February 2023 in available catalog records).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.140 (Hospital equipment); 83.140.99 (Other rubber and plastic products).
• Edition / version: 4th edition (2023).
• Number of pages: 11 pages.

Scope

ISO 10282:2023 applies to single‑use sterile rubber surgical gloves supplied packaged for surgical use and defines requirements intended to ensure protection against cross‑contamination in surgical environments. The standard excludes examination or other non‑surgical procedure gloves and does not prescribe sterilization, handling or storage practices. It covers gloves with smooth and with textured surfaces (in whole or in part).

Key topics and requirements

• Definition and classification of single‑use sterile surgical rubber gloves (material and intended use).
• General performance requirements addressing protection (barrier integrity) and safety for patient and user.
• Physical and dimensional properties (e.g., thickness, freedom from defects, surface texture options) and relevant test methods.
• Packaging, marking and labeling requirements to ensure traceability and sterility status on delivery.
• Sampling and conformity assessment principles for production lots (general guidance rather than national regulatory procedures).

Typical use and users

This standard is used by surgical glove manufacturers (product specification and quality control), hospital procurement and sterile supply departments (purchasing and acceptance criteria), regulatory bodies and conformity assessment bodies (reference for inspections and standards alignment), and testing laboratories that perform physical and sterility-related tests. It is intended for stakeholders concerned with surgical barrier performance and patient/user protection.

Related standards

ISO 10282:2023 replaces earlier editions of ISO 10282 (including the 2014 edition). Related standards include the ISO series addressing medical/examination gloves (for example ISO 11193‑1:2020 for single‑use medical examination gloves), and other regional or product‑specific standards for glove testing and packaging.

Keywords

surgical gloves, sterile gloves, single‑use, rubber surgical gloves, latex gloves, glove specification, barrier protection, packaging, ISO 10282:2023.

FAQ

Q: What is this standard?

A: ISO 10282:2023 is the International Standard that specifies requirements for packaged single‑use sterile rubber surgical gloves (fourth edition, published in February 2023).

Q: What does it cover?

A: It covers performance and safety requirements for packaged sterile rubber gloves intended for surgical use, including gloves with smooth or textured surfaces; it does not cover examination gloves or prescribe sterilization/handling procedures.

Q: Who typically uses it?

A: Manufacturers, hospital procurement/staff, testing laboratories, conformity assessment organizations and regulators use it as a technical reference for design, testing, purchase specifications and quality control.

Q: Is it current or superseded?

A: ISO 10282:2023 is the current published edition (it supersedes ISO 10282:2014 and earlier versions).

Q: Is it part of a series?

A: It is part of the family of ISO standards for single‑use medical and surgical gloves and sits alongside related documents such as ISO 11193‑1 (examination gloves) which address non‑surgical glove specifications.

Q: What are the key keywords?

A: Surgical gloves; sterile; single‑use; rubber; latex; barrier performance; packaging; ISO 10282:2023.