The European Union's Medical Device Regulation (MDR) No. 2017/745 introduces a comprehensive framework that significantly influences the supply chain of medical devices, including medical gloves, by emphasizing a risk-based classification system pivotal for ensuring user safety and device efficacy.
EN455-4:2009 is the European Standard that outlines the requirements and testing methods for determining the shelf life of single-use medical gloves. This includes surgical and examination gloves made from materials such as latex, nitrile, and polyisoprene. The standard emphasizes
In the realm of eco-friendly innovations, Biodegradable Nitrile Gloves have emerged as a pivotal development for both the healthcare sector and the environment. Understanding the benchmarks governing biodegradability becomes crucial as the world gravitates towards sustainable solutions that can
The EN455-3:2015 is an essential health and safety standard for medical gloves for single use, primarily focusing on the requirements and testing for biological evaluation. This guide will provide a simplified understanding of the EN455-3:2015 standard, its key components,
Understanding the EN455-2:2015 standard is crucial for manufacturers, distributors, and users of single-use medical gloves. This set of guidelines, ratified by the European Committee for Standardization (CEN), outlines the vital physical property requirements and testing methods to ensure optimal
In medical safety, the EN455-1 standard holds a pivotal position. It is a stringent regulation that sets forth the requirements and testing method for medical gloves for single-use to ensure freedom from holes, thereby reducing the risk of cross-contamination
Nitrile gloves are an essential type of personal protective equipment (PPE) widely used in the healthcare industry. These gloves designed to offer protection against a range of biological hazards, including chemicals and bloodborne pathogens. In this article, we delve
Protective gloves play a crucial role in safeguarding workers from various hazards in the workplace. The EN374 standard has become the cornerstone for evaluating and certifying the performance of protective gloves against chemicals and microorganisms. This comprehensive guideline impacts
