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Glossary of Glove Standards

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.

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
REGULATORY BODYSTANDARD NAMEDESCRIPTIONIMPORTANCE
American Society for Testing and Materials InternationalASTM 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 contentUsed 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 proceduresUse 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 glovesEvaluates 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 productsGives 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 glovesPowder 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 elongationAble 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 drugsAble 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 glovesProvides 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
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 plastic33
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 penetration3
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
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
REGULATORY BODYSTANDARD NAMEDESCRIPTIONIMPORTANCE
International Organisation for StandardisationISO 10282:2014, Single-use sterile rubber surgical gloves4Single-use sterile rubber surgical glovesEnsures sterile rubber gloves intended for use in surgical procedures are packed correctly to protect the patient and the user from cross-contamination
ISO 10993-54Test extractables on medical device materials for cytotoxicity using in vitro methodsMandatory for all medical devices and important in ensuring the biocompatibility of a medical device
ISO 10993-105Test extractables on medical device materials for sensitising chemicals that can lead to sensitisation and irritationMandatory for all medical devices and important for staff and patient safety against allergic reactions
ISO 11193-1Specification for gloves made from rubber latex or rubber solutionProvides guidance for the acceptable level of safety required for rubber gloves to prevent cross-contamination for users and patients

References

  1. Standards New Zealand 2017, About us, viewed 2 March 2020, <https://www.standards.govt.nz/about-us/>
  2. ASTM 2020, Detailed Overview, viewed 2 March 2020, <https://www.astm.org/ABOUT/full_overview.html>
  3. European Committe for Standardisation 2020, Who we are, viewed 2 March 2020, <https://www.cen.eu/about/Pages/default.aspx>
  4. ISO, About Us n.d., viewed 2 March 2020, <https://www.iso.org/about-us.html>
  5. Wallin, 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>