Glossary of Glove Standards

Glove standards are essential to ensuring you can trust their quality, suitability and reliability when you put them on. The most widely adopted technical standards for examination and surgical gloves are developed and maintained by Standards Australia/Standards New Zealand (AS/NZS), the International Organisation for Standardisation (ISO), the European Committee for Standardisation (CEN) and the American Society for Testing and Materials International (ASTM).

Gathered here are some of the most commonly used glove standards to look for, what they measure, and why they are important.

Table 1: Glove Standards: Australia/New Zealand Standards

REGULATORY BODY	STANDARD NAME	DESCRIPTION	IMPORTANCE
Standards Australia/Standards New Zealand	AS/NZS 4011.1:2014 Standards Australia Limited/Standards New Zealand 2014, Single-use medical examination gloves Part 1: Specification for gloves made from rubber latex or rubber solution1	Specification for single-use rubber examination gloves to determine performance, safety and proper use	Provides the acceptable level of safety required of exam gloves to prevent cross-contamination for users and patients
	AS/NZS 4179:2014 Single-use sterile rubber surgical gloves–Specification1	Specification for single-use sterile surgical gloves to determine performance, safety and proper use	Provides the acceptable level of safety required of surgical gloves to prevent cross-contamination for users and patients

Table 2: Glove Standards: American Society for Testing and Materials International

REGULATORY BODY	STANDARD NAME	DESCRIPTION	IMPORTANCE
American Society for Testing and Materials International	ASTM D3577-19 Standard Specification for Rubber Surgical Gloves2	Specification for sterile rubber surgical gloves made from natural rubber latex or synthetic rubber latex. Tests for sterility, freedom from holes, physical dimensions, tensile strength, ultimate elongation, stress at elongation, powder-free residue, powder amount, protein content, and antigenic protein content	Used to assess conformance of rubber surgical gloves to meet safety and performance requirements for surgical procedures
	ASTM D3578-19 Standard Specification for Rubber Examination Gloves2	Specification for natural rubber examination gloves. Tests for sterility, freedom from holes, physical dimensions, tensile strength, ultimate elongation, stress at elongation, powder-free residue, powder amount, protein content, and antigenic protein content Use to assess conformance of natural rubber exam gloves to meet safety and performance requirements for medical procedures	Use to assess conformance of natural rubber exam gloves to meet safety and performance requirements for medical procedures
	ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves2	Testing to detect pinholes in medical gloves	Evaluates the quality of medical gloves for their barrier protection
	ASTM D5712-15 Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method2	Testing to determine protein level in natural rubber, latex and elastomeric products	Gives guidance to the protein levels linked to latex
	ASTM D6124-06(2017) Standard Test Method for Residual Powder on Medical Gloves2	Residual powder and non-powder solids found on medical gloves	Powder in medical gloves has been associated with infection and allergic risks
	ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application2	Specification for nitrile examination gloves for medical application. Tests for sterility, freedom from holes, physical requirements before and after ageing, amount of powder on the glove, tensile strength and ultimate elongation	Able to assess conformance of nitrile rubber gloves to meet safety and performance requirements for medical procedures
	ASTM D6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs2	Resistance of medical gloves to permeation by chemotherapy drugs	Able to assess chemotherapy breakthrough times across medical glove materials to determine the safest glove choice
	ASTM D7102-17 Standard Guide for Determination of Endotoxin on Sterile Medical Gloves2	Testing for bacterial endotoxins on sterile medical gloves	Provides quality control to ensure that sterile gloves only contain a low number of endotoxins
	ASTM F1671 / F1671M-13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System2	Testing the penetration of blood-borne pathogens in protective clothing (including gloves)	Provides quality control to ensure that personal protective clothing passes detection of viral penetration for worker safety

Table 3: Glove Standards: European Committee for Standardisation

REGULATORY BODY	STANDARD NAME	DESCRIPTION	IMPORTANCE
European Committee for Standardisation	CEN/TS 14234:2002 Materials and articles in contact with foodstuffs – polymeric coatings on paper and board – guide to the selection of conditions and test methods for overall migration3	Technical specification for materials and articles in contact with foodstuffs	Tests the overall migration from polymeric coatings on paper and board that are planned to contact foodstuffs
	EN 1186	Specification for plastic materials and articles in contact with foodstuffs	Ensures gloves and other equipment is safe for food contact
	EN 13130-1:2004 Materials and articles in contact with foodstuffs – plastics substances subject to limitation – part 1: guide to test methods for the specific migration of substances from plastics to foods and food simulants and the determination of substances in plastic3	Specification for limited plastic substances related to materials and articles that contact foodstuffs	Tests for specific migration of article with food simulants to determine appropriate conditions
	EN 16523-1 Chemical permeation testing of gloves3 *Supersedes EN 374-3	Determination of glove materials resistance to chemicals through chemical permeation testing under continuous contact	Assesses the performance of gloves against hazardous chemicals to determine the correct level of protection
	EN 374-2 Protective gloves against dangerous chemicals and micro-organisms – part 2: determination of resistance to penetration 3 *Superseded by EN ISO 374-2	Determination of glove penetration resistance for protection against dangerous chemicals and/or micro-organisms	Assesses the protective quality of gloves by ensuring the absence of pinholes
	EN 374-4 *Superseded by EN ISO 374-4	Determination of glove chemical degradation resistance for protection against dangerous chemicals and/or micro-organisms	Assesses the protective quality of gloves by evaluating any physical property changes following continuous chemical exposure
	EN 374-5:2016 Protective gloves against dangerous chemicals and microorganisms — Part 5: Terminology and performance requirements for micro-organisms risks3 *Superseded by EN ISO 374-5	Terminology and performance requirements for risks with micro-organisms	Assesses the protective quality of gloves based on its protective features and determines if amendments are required
	EN 420:2003 + A1:2009 Protective gloves. General requirements and test methods3	Determination of general requirements and test methods for protective gloves	Ensures that gloves are made without the presence of pinholes
	EN 455-1	Determination of freedom from holes through a water leak test	Ensures that gloves are made without the presence of pinholes
	EN 455-2	Determination of physical properties to provide adequate protection from cross contamination for both patient and user	Aims to minimise risks associated with glove breakage and ensures the material is comfortable and conforms to the wearer’s hands
	EN 455-3	Evaluation of biological safety for medical gloves for single use by measuring for endotoxins, powder residue and leachable proteins in latex gloves	Aims to minimise risks associated with powder and proteins for the user and patient and the risk of infection from endotoxins on non-sterile gloves
	EN 455-4	Determination of shelf life for single-use medical gloves	Ensures the accuracy of shelf life claims for gloves through stability tests
	EN ISO 374-1 (Type A, B, C)	Terminology and performance requirements for risks with chemicals	Evaluates three different chemical test groups to determine the material’s breakthrough times for each

Table 4: Glove Standards: HACCP

REGULATORY BODY	STANDARD NAME	DESCRIPTION	IMPORTANCE
HACCP Australia	HACCP	Specialises in the practice and implementation of food safety measures and protocols across food and beverage industries, including food safety certification and comprehensive programmes	Ensures product meets industry expectations and best practice for food integrity and safety

Table 5: Glove Standards: International Organisation for Standardisation

REGULATORY BODY	STANDARD NAME	DESCRIPTION	IMPORTANCE
International Organisation for Standardisation	ISO 10282:2014, Single-use sterile rubber surgical gloves 4	Single-use sterile rubber surgical gloves	Ensures sterile rubber gloves intended for use in surgical procedures are packed correctly to protect the patient and the user from cross-contamination
	ISO 10993-5 4	Test extractables on medical device materials for cytotoxicity using in vitro methods	Mandatory for all medical devices and important in ensuring the biocompatibility of a medical device
	ISO 10993-10 5	Test extractables on medical device materials for sensitising chemicals that can lead to sensitisation and irritation	Mandatory for all medical devices and important for staff and patient safety against allergic reactions
	ISO 11193-1	Specification for gloves made from rubber latex or rubber solution	Provides guidance for the acceptable level of safety required for rubber gloves to prevent cross-contamination for users and patients

¹Standards New Zealand 2017, About us, viewed 2 March 2020, <https://www.standards.govt.nz/about-us/>

²ASTM 2020, Detailed Overview, viewed 2 March 2020, <https://www.astm.org/ABOUT/full_overview.html>

³European Committe for Standardisation 2020, Who we are, viewed 2 March 2020, <https://www.cen.eu/about/Pages/default.aspx>

⁴ISO, About Us n.d., viewed 2 March 2020, <https://www.iso.org/about-us.html>

⁵Wallin, R.F. 1998 ‘A Practical Guide to ISO 10993-10: Sensitization’, Medical Device and Diagnostic Industry, viewed 2 March 2020, <https://www.mddionline.com/practical-guide-iso-10993-10-sensitization>