Gloves are an essential tool for healthcare professionals. Gloves provide protection for all staff, patients and visitors that has been proven to help prevent the transmission of pathogens. Gloves come in a variety of shapes and sizes, which can be confusing in practice. To make matters worse, not all gloves are suitable for healthcare work.
Furthermore, examination gloves must meet a number of requirements and standards that are specified in European guidelines. Nitrile gloves are made of synthetic rubber, very comfortable and stronger than latex. Nitrile gloves contain no latex and can be used for a wide range of activities with the correct certifications. Among other things, they are ideal for tasks that may involve contact with blood and other body fluids. In order to be allowed to use a glove in the medical field, various guidelines must be met.
In the following we would like to provide clarification regarding a few standards:
The Medical Device Directive is one of the three most important directives for medical devices. This directive regulates the free movement of goods for medical devices throughout Europe and only allows safe products that have been manufactured based on the uniform requirements. These requirements essentially state that
The medical devices are fit for purpose.
To develop, verify and validate the life cycle processes according to standardized software.
The electrical and mechanical safety of the products must be guaranteed.
Technical documentation is mandatory for all manufacturers to assess these requirements. Standards are to be applied here in order to provide evidence that all essential requirements are met. Articles 5 to 7 concern so-called “harmonized standards”. Manufacturers affix the CE mark to their own medical products in accordance with Article 17, thereby declaring conformity with the basic requirements of the Medical Devices Directive (93/42/EEC). However, manufacturers must of course first go through strict conformity assessment procedures.
The conformity assessment procedures that can be selected depend on the class of the medical device according to Article 9 and Annex IX. The Medical Devices Directive 93/42 describes these different variants in Article 11 and in Annexes II to VII. The content of the technical documentation essentially does not differ between the different variants. However, the conformity assessment procedure according to Annex II requires a complete quality management system.
For our nitrile gloves, this means that they can be sold and used throughout Europe, as they meet all quality standard requirements.
The abbreviation "REACH" is derived from the English title of the regulation: Regulation concerning the Registration, Evaluation, Authorization and Restriction of CHemicals. Since 2007, this directive has made a major contribution and represents a high level of protection for human health and the environment. At the same time, however, it is intended to ensure the free movement of chemicals on the internal market and to promote competitiveness and innovation. REACH is based on the principle that manufacturers, importers and downstream users take responsibility for their chemicals. They must ensure that chemicals they manufacture and place on the market are used safely.
REACH is not only one of the most modern and at the same time strictest chemical laws, it is also a very detailed set of rules. Manufacturers and importers of chemicals now have to submit specific data through registration and assess the risks emanating from the substances themselves. This means that chemicals cannot be placed on the market without a corresponding registration. The task of the authorities is to support the actors, to check the registrations and to regulate substances with properties of particular concern or substances that could lead to risks for humans or the environment. Other important points were also clarified with REACH. Consumers have the right to receive information about chemicals in products. Furthermore, the transfer of data within the supply chain is regulated, while the substitution of substances of very high concern is promoted. The authorization process creates another way to regulate chemicals.
For the production of our nitrile gloves, this guideline creates important points of contact in terms of the safe basic material nitrile. Nitriles are a group of chemical compounds with the general formula R-C≡N. Formally, the harmless nitriles are derived from hydrocyanic acid (HCN) by replacing the hydrogen atom with an organic residue. Industrially, nitriles are produced by hydrocyanation (addition of HCN to alkenes) and by catalytic oxidation of alkenes and ammonia with air. Nitrile polymers are chemically very resistant and have rubber-like properties, which is why they are perfect for the manufacture of our protective gloves and are used accordingly. Since the manufacturing process and the raw materials are chemically combined, the REACH regulation applies here.
The new European regulation (EU) 2016/425 regarding personal protective equipment (PPE) was published in the Official Journal of the European Union on March 31, 2016 and was to be applied as of April 21, 2018 after a lead time of two years. At that time, the new PPE regulation replaced the previous Directive 89/686/EEC. As part of the changeover, manufacturers of PPE products have to take a number of changed criteria into account. The experts at DGUV Test provide support with the transition to the new regulation (EU) 2016/425 and with the conformity assessment procedures for the required EU type examination certificates.
The regulation also requires the following information in the "technical documentation" ((EU) 2016/425 Annex II, 1.4; Annex III; Annex V, Module B):
A complete description of the PPE and its intended use
An assessment of the risks the PPE is designed to protect against.
The references of the harmonized standards used in the design and manufacture of the PPE.
Studies to verify the conformity of PPE.
Reports on the tests carried out to determine the respective protection class.
Regulation (EC) No. 1935/2004, the so-called framework regulation, passed by the European Parliament and the Council of the EU on October 27th (2004) applies to all materials used in contact with food.
Article 3 of the Regulation mentions the "general requirements". The most important statement is: Materials and objects must be manufactured in such a way that under normal and foreseeable conditions of use their material components are only transferred to the food in quantities that in no way endanger the health of the consumer.
Materials that come into contact with food should be made in such a way that, if possible, no substances are transferred from them to the food. If this does happen, according to Article 3 of EU Regulation 1935/2004, only such small amounts may migrate to the food
That do not endanger human health,
Which do not lead to an unacceptable change in the composition of the food,
and which do not lead to an impairment of the smell and taste of the food.
There is no special approval procedure for materials that come into contact with food. However, there are the aforementioned requirements of EU Regulation 1935/2004 that all materials and their components must meet if they are to be used in contact with food. The manufacturers are responsible for this. Regulation (EU) No. 10/2011 has been in force since 2011, with which a directly legally effective European regulation came into force. It establishes a mandatory positive list of monomers and additives that may be used in the manufacture of plastic food contact materials and articles. Before they are included in these lists, the substances must be checked for their possible migration to food and their toxicological properties. As a result of the test, limit values for the transfer of substances to food are set. This means that toxicological data is available for substances included in the lists, which makes it much easier to assess the health risk in the event of a transition to food.
Our chemists and regulatory affairs experts have interdisciplinary expertise and in-depth experience in the manufacture of nitrile gloves. In the context of the regulations, you are instructed to see these regulations only as a minimum quality standard in order to guarantee comprehensive quality for our customers and the end consumer.