People often ask us about the pricing of our disposable gloves, claiming that they cost more than some of our competitors’ products. Here’s why:
Here at Hcsuk, we are passionate about ONLY providing you with fit for purpose products that meet industry standards. Helping you get peace of mind that you are providing adequate protection for your staff and residents.
Never has this been more important to understand and to protect your staff and residents effectively with the correct level of protection of PPE, than right now when we are dealing with a pandemic.
So, what do you know about important legislation concerning the quality of ‘medical devices’ including latex, nitrile and vinyl examination gloves sold in Britain?
Many in the British healthcare industry buy gloves based on price alone and are unaware of the EU’s Medical Device Directive 93/42/EEC.
Under this Directive, medical gloves have to meet requirements of a Europe wide safety standard, BS EN455 Medical Gloves for Single Use 2000.
BS EN 455 sets Acceptable Quality Levels (AQL) for the gloves ‘freedom from holes’. This is always presented as a number: the lower the AQL the better the quality. AQL 1.5 is the norm in healthcare. Any gloves NOT sold as AQL 1.5 to the healthcare industry are DANGEROUS since protection from blood and bodily fluids is so critical, and gloves with an AQL higher than 1.5 DO NOT protect against blood borne viruses.
The EU’s Medical Device Directive 93/42/EEC covers four major parts as detailed below: –
Part 1 is designed to prevent low quality gloves (and other devices) getting into NHS, private healthcare hospitals and care homes, to reduce potential danger of harm to nurses or patients.
Part 2 covers requirements and testing for physical properties – these tests are on the gloves dimensions and cover physical strength of the gloves, making sure they are suitable for use within healthcare environments.
Part 3 covers requirements and testing for the biological evaluation – this is the standard that includes tests for potential hazardous materials that may affect the wearer or be transferred to the patient.
Part 4 of the directive covers the shelf life determination – will the glove protect and perform as well over time. As many homes/distributors/hospitals buy in bulk and gloves are stored in a variety of locations and establishments, this part of the directive makes sure variables are taken into account to make sure the gloves can be stored and used as intended over a longer time frame.
Here at Hcsuk, we are passionate about providing fit for purpose products that meet industry standards to help give you peace of mind that you are providing adequate protection for your staff and residents.
We pledge to consistently provide you with gloves which meet all of these standards, we will not compromise on your safety and we have full certification to prove it!
If you have any doubts or concerns about the quality of gloves you are currently receiving from another company, whether that be tearing, causing skin allergies, or staff complaining about the quality then please get in touch today to arrange your FREE no-obligation glove audit and consultation.
We hope you’ve found this information insightful. Why not leave a comment or suggestion below!