Standards and regulations

MD and PPE standards and regulations

Depending on the purpose of the single-use protective gloves, manufacturers refer to the relevant European standards and regulations in order to meet the general requirements of these regulations. The following table lists the main applicable standards for single-use protective gloves.

As a reminder, when protective gloves are used in contact with patients, they must comply with the Medical Devices regulation: European Medical Devices Regulation 2017/745EU and meet all the specifications of the European technical standards:

The gloves must also comply with the European Personal Protective Equipment Regulation 2016/425EU and meet all the specifications of numerous European technical standards:

Thus, a PPE glove claiming protection against high risks will have to be considered as category III PPE, and the entire CE marking file will have to be analyzed by a notified body with regard to the PPE regulation. This body will draw up a declaration of type approval and will require the manufacturer to affix a certain number of references to the packaging of the gloves concerned, in particular the CE symbol followed by the 4 digits of the notified body.

The standards used for compliance with the PPE Regulation complement the specifications of the standards related to the MD Regulation. The definitions and basic requirements of EN374-1 are as follows (extracted from the standards of the EN-374-n series): Standard EN ISO 374-1

Degradation

Transformation with deterioration of one or more properties of the material of a protective glove, following contact with a chemical product. Signs of degradation: flaking, swelling, disintegration, embrittlement, discolouration, dimensional variations, appearance, hardening, softening…

Penetration

Passage of a chemical through materials, seams, holes and other imperfections present in the material of a protective glove at the non-molecular level. These must not leak when tested in accordance with EN 374-2:2019: 7.2 and 7.3 air and water tightness respectively.

Permeation

The process by which a chemical migrates through the material of a protective glove at the molecular level.

For hand protection in the COVID-19 crisis, manufacturers must demonstrate the barrier effectiveness of their gloves against viruses.

The notified body will analyze the manufacturer’s CE marking file together with the analysis and test certificates, in particular the test results with regard to the standards EN374-2, EN374-5. If the manufacturer obtains a positive result from the notified body regarding this protection, he must affix the logo as shown below:

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MD and PPE standards and regulations