Medical Gloves
Medical gloves play a pivotal role within healthcare settings due to their profound impact on ensuring the safety and well-being of healthcare workers and patients. Surgical and examination gloves need to be able to exhibit a minimum strength, possess barrier protection against microorganisms during use and fit the user correctly. They should also be safe for the user to wear and have a reasonable shelf life.
In Europe it is becoming common practise for procurement bodies to request independent test reports stating compliance with the EN 455 suite of standards from ISO 17025 accredited laboratories. Independent testing can demonstrate that medical gloves meet the appropriate performance requirements. These tests help maintain high safety and quality standards in healthcare settings, protecting both medical professionals and patients.
EN 455 - Freedom from holes
EN 455-1 tests verify that gloves are free from holes and can therefore effectively prevent the transmission of bacteria and viruses between healthcare workers and patients. Samples are taken from a batch of gloves and undergo checks for pinholes and leaks.
There are different performance requirements for examination and surgical gloves. Medical examination gloves must achieve an acceptable quality level of 1.5 (AQL 1.5), whereas surgical glove have a more stringent AQL 0.65 requirement i.e. an AQL of 0.65 means that no more than 0.65% of gloves can have defects.
EN 455-2 – Physical properties
Medical grade gloves must meet certain labelling, dimensional and physical strength requirements. Depending on the type of glove under test, EN 455-2 stipulates different strength performance requirements. Surgical gloves must meet a minimum force at break of 9 newtons (N).
For examination gloves, the standard stipulates different force at break depending on the glove material. Thermoplastic examination gloves, such as vinyl and polyethylene materials, must be able to withstand a force of 3.6 N, whereas all other examination gloves, such as nitrile and latex materials have a 6 N requirement.
Medical gloves should maintain their strength throughout their shelf-life and following challenge testing, where gloves are placed into an ageing oven for 7 days at a temperature of 70°C and then tested.
EN 455-3 – Requirements for biological evaluation
This standard outlines requirements and test methods for the evaluation of potentially hazardous materials that may affect the wearer or be transferred to a patient. These materials include endotoxins, latex proteins, chemical residues and surface powder. The standard also covers the limitations on product labelling.
Removable Surface Powder
Powdered medical glove pose several risks for wearers and patients. Powder has been linked to the development of adhesions and granulomas, elevated risk of cross-infection and can exacerbate exposure to latex allergens and cause Type I hypersensitive reactions.
For gloves claimed to be powder-free the total quantity of powder residues determined using BS EN ISO 21171 method shall not exceed 2 mg per glove. Any glove containing more than 2 mg powder is deemed a powdered glove.
EN 455-4 – Requirements and testing for shelf-life determination
This part of the standard outlines the protocols to evaluate the shelf life of medical gloves, ensuring they remain effective and safe to use over time. The testing can be performed using real-time studies or validated accelerated ageing alternative methods.
Relevant Standards
- EN 455-1 - Medical gloves for single use: Requirements and testing for freedom from holes
- EN 455-2 - Medical gloves for single use: Requirements and testing for physical properties
- EN 455-3 - Medical gloves for single use: Requirements and testing for biological evaluation
- EN 455-4 - Medical gloves for single use. Requirements and testing for shelf life determination
- BS EN ISO 21171 - Medical gloves. Determination of removable surface powder