Our leadership in the field of gloves protecting against chemical risks has enabled us to develop
the expertise required for medical grade gloves.

Medical grade gloves are mainly used to provide an appropriate level of protection for the patient and the wearer against cross-contamination. The types defined by standard EN 455-2 are as follows:

  • disposable surgical: gloves intended for use in the medical sector to protect the patient and the wearer against cross-contamination
  • surgical: sterile, anatomically shaped medical gloves with the thumb positioned towards the palmar surface of the index finger rather than lying flat, and intended for use in invasive surgery
  • examination gloves and/or procedure gloves: sterile or non-sterile medical gloves, which may or may not be anatomically shaped, intended for conducting medical examinations, diagnostic and therapeutic procedures and for handling contaminated medical material

How to proceed

For all three types (disposable surgical, surgical, examination and/or procedure gloves) the medical grade gloves must comply with the provisions of Regulation EU 2017/745. Our laboratories verify conformity according to the following 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 physical properties

EN 455-4

Medical gloves for single use – Requirements and testing for shelf life determination

EN ISO 10993-1

Biological evaluation of medical devices: Evaluation and testing

EN ISO 10993-5

Biological evaluation of medical devices: in vitro cytotoxicity testing

EN ISO 10993-10

Biological evaluation of medical devices: Tests for irritation and delayed-type hypersensitivity

EN ISO 10993-18

Biological evaluation of medical devices: Chemical characterization of medical device materials within a risk management process

EN 1041

Information supplied by the manufacturer of medical devices

EN ISO 15223-1

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied

When testing is complete, you will have to:

  • prepare the technical file in compliance with Annex II to Regulation (EU) 2017/745
  • apply the CE marking on the Medical Device
  • prepare the EU declaration of conformity (Annex IV to Regulation (EU) 2017/745), complete with an indication of the SRN (supplier’s unique code) and UDI D (device’s unique code)
  • register with the Database of the Ministry of Health and the European EUDAMED

Intervention from a notified body is only required for examination and/or procedure gloves subjected to a sterilization process (Category Is) and for surgical gloves intended for use in invasive surgery (Category IIa).

Keep the EU declaration of conformity and the technical file for 10 years from when the Medical Device is placed on the market.

If the gloves are also PPE, they must also meet the requirements of Regulation EU 2016/425.

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