Medline is ISO 13485-2012 certified. Medline has been manufacturing protective apparel for over 40 years.
Why choose Medline?
Why are more hospitals and purchasing groups choosing Medline for their all-around protection?
We know you rely on disposable apparel to keep your staff protected and comfortable. For this reason, we use fine materials available for protection, offering a great level of comfort. We apply high quality standards to our products in our manufacturing facilities.
EU Directives to classify protective apparel
Directive 93/42/EEC: applies to medical devices and their accessories. Medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer. These products are Class I non-sterile as they are used to limit cross contamination.
Directive 89/686/EEC1: commonly referred to as PPE (Personal Protective Equipment), this text lays down the conditions governing its placing on the market and free movement within the community and the basic safety requirements which PPE must satisfy in order to ensure the health protection and safety of users.
How to choose the right material: