Understanding 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>