Disposable Gloves Testing & Certification

Testing Services for Disposable Gloves

Disposable gloves can be Medical Devices, Personal Protective Equipment (PPE) or both, as per the European Regulation of medical devices and PPEs Regulation. We offer disposable gloves testing per European market standards and U.S. market standards.

When forming part of PPE, gloves fall under Category III PPE and, in addition to undergoing a certification process by an EU Notified Body (our lab in Spain is a Notified Body), they need to meet one of the following requirements: conformity to type based on internal production control (Module C2), or conformity to type based on quality assurance (Module D).

Medical gloves for chemical or biological use

For the European market, disposable gloves which are used to protect the user from chemical or biological risks must observe the following standards, according to the Regulation (EU) 2016/425:

• EN ISO 21420 – Protective gloves - General requirements
• EN ISO 374-1:2016/A1:2018 - Protective gloves against dangerous chemicals and micro-organisms - Part 1: Terminology and performance requirements for chemical risks
• EN ISO 374-2 Penetration: water leak and air leak
• EN ISO 374-4 Chemical degradation
• EN ISO 374-5:2016 - Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks
• EN 16523-1 Chemical permeation
• ISO 16604, Procedure B: Protection against viruses (optional test)

Medical gloves for preventing spread of infection or illness – EU standard

Disposable medical gloves which are used to prevent the spread of infection or illness must observe the following standards, according to the Medical Devices Directive 93/42/EEC:

• 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 biological evaluation
• EN 455-4 - Medical gloves for single use. Requirements and testing for shelf life determination

Medical gloves for preventing spread of infection or illness – US standard

For the U.S. market, however, disposable medical gloves should be tested according to ASTM standards, depending on the type of gloves and its use:

• ASTM D6319 - Specification for Nitrile Examination Gloves for Medical Application
• ASTM D3578 - Specification for Rubber Examination Gloves
• ASTM D5250 - Specification for Poly(vinyl chloride) Gloves for Medical Application
• ASTM D3577 - Specification for Rubber Surgical Gloves

Testing for food contact gloves and single-use nitrile gloves

Food contact gloves: Food contact gloves testing under EN 1186. Plasticisers and other substances may migrate from the gloves into the handled food, compromising it. Overall and specific migration testing in accordance with EN 1186 for different food simulants.

Single-use nitrile gloves: Testing to ISO/IEC 17025:2017 and testing of water and air leakage against ISO 374.

Notified Body service

CE-marking is a mandatory conformity mark which is required for PPEs in Europe. It signals that products are safe and compliant with European Regulation (EU) 2016/425.

Eurofins Textile Testing Spain, S.L.U. is a Notified Body (2865) for Personal Protective Equipment (PPE), with focus on protective clothing and footwear, providing both, testing and certification services to ensure the compliance of your gloves –among other PPE products- against the concerned European regulation EU 2016(425).

Recently, Eurofins Textile Testing Spain has expanded its PPE testing ISO 17025 accredited capabilities, find out more about our expanded capabilities.

Find out more about our full-scope PPE certification services if you need assistance on this.

For more details, please contact us anytime!