GOST R 52238-2004 PDF

Full title and description

GOST R 52238-2004 — Single-use sterile rubber surgical gloves. Specification. (National adoption of ISO 10282:2002; establishes requirements for packaged sterile single-use latex surgical gloves intended to protect patient and user from cross-contamination during surgical procedures).

Abstract

This standard specifies performance, design, material and marking requirements, sampling and test methods, inspection rules, packaging and storage for single-use sterile rubber (latex) surgical gloves. It is a Russia-adopted modification of ISO 10282:2002 and includes national editorial or technical clarifications and later amendment(s) to referenced test standards.

General information

• Status: Active (national standard of the Russian Federation; implemented 1 January 2005 and maintained with later amendment(s)).
• Publication date: Adopted/approved 2004; introduced into effect 1 January 2005.
• Publisher: Approved/issued by Gosstandart / Federal Agency on Technical Regulating and Metrology (Rosstandart).
• ICS / categories: Corresponds to hospital equipment and rubber products classifications (ICS: 11.140; OKS/ОКС: 83.140).
• Edition / version: GOST R 52238-2004 (national adoption of ISO 10282:2002); contains Amendment No.1 introduced by order of the competent authority (effective 1 January 2011).
• Number of pages: Typically published as a short technical specification (listed as ~12 pages in standard catalogs).

Scope

Defines technical and safety requirements for packaged, sterile, single-use surgical gloves made of rubber (natural latex). Excludes non-sterile examination/procedure gloves and covers both smooth and textured-surface surgical gloves; scope covers design, materials, performance tests, sampling, inspection, labelling, packaging and storage applicable to gloves intended for use during surgical operations.

Key topics and requirements

• Material and construction requirements for latex surgical gloves (composition, absence of unacceptable defects).
• Physical and mechanical performance: dimensions, strength, leak/impermeability tests, elongation and tensile properties.
• Sterility and packaging: requirements for sterile condition, packaging integrity and labelling of sterile single-use packs.
• Sampling and acceptance rules: statistical sampling plans and inspection levels for production lots.
• Referenced biological and safety tests: biocompatibility/ISO 10993-series referenced for cytotoxicity/irritation and systemic toxicity considerations.
• Marking, instructions for use, storage and expiration considerations to ensure product safety and traceability.

Typical use and users

Used by medical device manufacturers, quality and regulatory specialists, testing laboratories, procurement and hospital supply departments, and conformity assessment bodies involved in production, certification and release of sterile surgical gloves for clinical/surgical use. Also referenced by registrants preparing conformity declarations and technical files for the Russian market.

Related standards

Directly related to ISO 10282 (the international specification for single‑use sterile surgical gloves) and to standards in the ISO 10993 biocompatibility series and national test-method standards referenced by the text. Other related / replacement editions of ISO 10282 (e.g., later 2014 and 2023 editions) and national amendments should be checked when updating technical files.

Keywords

GOST R 52238-2004; surgical gloves; single-use; sterile; latex; rubber; specification; ISO 10282; biocompatibility; packaging; sampling; Rosstandart.

FAQ

Q: What is this standard?

A: A Russian national standard (GOST R 52238-2004) that specifies requirements for single-use sterile rubber (latex) surgical gloves; it is a national adoption/modification of ISO 10282:2002.

Q: What does it cover?

A: Performance and safety requirements, test methods, sampling/acceptance rules, marking, packaging and storage for sterile single-use surgical gloves intended to protect patient and user from cross-contamination during surgery. It does not apply to non-sterile examination gloves.

Q: Who typically uses it?

A: Manufacturers of surgical gloves, conformity assessment and testing laboratories, hospital procurement and QA/regulatory teams preparing technical documentation and declarations of conformity for the Russian market.

Q: Is it current or superseded?

A: GOST R 52238-2004 was introduced into effect on 1 January 2005 and has at least one national amendment; users should verify whether a later national replacement or a newer adoption aligned to subsequent ISO editions exists before relying on it for certification or procurement. (Check current Rosstandart catalogs or official registries for the absolute latest status.)

Q: Is it part of a series?

A: It is the national adoption of the ISO 10282 family (standards for single‑use sterile surgical gloves) and is commonly used alongside referenced standards such as the ISO 10993 biological evaluation series and national test-method standards.

Q: What are the key keywords?

A: Surgical gloves, single-use, sterile, latex, rubber, specification, ISO 10282, biocompatibility, packaging, sampling, GOST R.