Discover our wide range of disposable and reusable nitrile gloves for the food and medical industries at the best price. Discover the Kolmi Coverfeel disposable nitrile glove, made in France, which reduces allergies.
Nitrile gloves for professionals: the qualities
The emergence of nitrile has seen its rise in the world of disposable gloves, in particular with the aim of providing an alternative to latex gloves, which could present allergy risks. It therefore remains the most widely used glove in the catering and food preparation world and in the healthcare sector.
To date, the majority of manufacturing comes from Asian countries such as China, Malaysia, etc., but Medicom Kolmi created a manufacturing chain in France after the Covid crisis, integrating 3 nitrile references.
Compliance with French food standards decree 08/2020 , reduction of type IV allergies , resistance to chemicals and cytotoxic products (ASTDM D6978-05) ... so many differences for "Made In France".
What you need to understand and know before choosing your nitrile glove
The advantages of nitrile gloves
The choice of nitrile gloves, which is becoming increasingly popular, is not random, and it does indeed have many strong points, even if latex remains very effective against biological contamination, with remarkable elasticity and comfort.
Synthetic rubber, therefore ideal for users sensitive to latex gloves and, more generally, those with allergies to natural latex.
Higher protection against punctures, chemicals and contamination.
Greater dexterity thanks to high elasticity, optimal fit and textured fingertips (on certain manufactures) for precise handling of tools, food and medical utensils.
Greater comfort with tactile sensitivity almost equal to a latex glove and superior comfort during prolonged use.
Resistance of the order of 3 times greater than a latex glove with increased longevity.
Food use framework for the glove
This is the area where it is necessary to understand the issues, particularly those of "migration" . The concept of food contact, symbolized by a picrogram including a fork and a glass, is found on ALL products or equipment that may come into contact with food.
But of course, from one product to another, the regulatory framework is very different if it is a detergent, a cloth, a broom and therefore personal protective equipment such as a glove.
This compliance ensures the health safety of trades and utensils intended to come into contact with food. The glove is therefore at the heart whether in preparation (central kitchen, restaurant, food industry...) or in a local business such as butcher, caterer, takeaway, delicatessen... and finally at the level of the service in the room at the level of a community (self-service, school restaurant....
To be suitable for food contact, a glove must meet three different regulations:
- European Regulation (EU) No. 1935/2004 - General requirements - Principles of inertia and safety.
- Commission Regulation (EC) No 2023/2006 of 22 December 2006 - Good Manufacturing Practices.
- And finally depending on the type of materials:
PLASTIC (vinyl, PE & TPE gloves) Regulation (EU) No 10/20011 | RUBBER (nitrile and latex gloves) National Regulation applies: French decree of August 5, 2020 |
1 - Positive composition list: list of substances that can be used in the composition; it is strictly forbidden to incorporate a substance that is not on the positive list. The manufacturer must check that all the components of the glove are listed. 2 - Global (stability) and specific (dangerous substances) migration tests. 3 - Additional tests in accordance with Regulation (EC) 1935/2004 (organoleptic tests and migration of substances with restrictions). |
Permeation and resistance of nitrile gloves to chemicals
Another glove characteristic to check is its resistance and permeation capacity, particularly when we talk about risks related to protection against chemical products. Whether in an industrial environment, in cleaning and maintenance, or in a medical environment with the possible handling of aggressive substances such as cytotoxic substances.
The standards relating to chemical risks are as follows:
• ISO 374-1:2016+A1:2018 which refers to “Terminology and performance requirements for
chemical risks”.
• EN 16523-1:2015+A1:2018 which refers to “Permeation by liquid chemical in
continuous contact conditions”.
• ISO 374-2:2019 which refers to “Determination of resistance to penetration”.
• ISO 374-4:2019 which refers to “Determination of resistance to degradation by chemicals”/ (% change in puncture resistance before and after chemical exposure).
Regulation on single-use gloves for medical devices, standard EN 455
One area where disposable gloves, and more specifically nitrile gloves, are used is the healthcare sector. Kolmi also has a significant market share, supported by the French government, with its range of nitrile gloves manufactured in France in the hospital sector.
The reference series of standards is the European standard EN 455 relating to single-use medical gloves (MD) .
This standard is divided into 4 distinct parts and aims to create a protective barrier between the patient and the user against any risk of cross-contamination.
EN 455-1:2020+A2:2024 Requirements and tests on hole detection
Gloves must pass a watertightness test for hole detection . This test is carried out on a statistical sample (taken in accordance with ISO 2859-1).
EN 455-2:2024 Requirements and tests on physical properties
This standard specifies requirements and test methods for the physical properties of medical gloves , such as dimensions and breaking strength before and after accelerated aging.
EN 455-3:2023 Requirements and tests for biological evaluation
This standard describes requirements and test methods for assessing the biological safety of medical gloves .
This involves evaluating data such as:
1. Endotoxin content (for sterile gloves only)
2. The quantity of powder
3. Chemical compounds used in manufacturing processes - accelerators, antioxidants, biocides
4. Extractable proteins (for latex gloves)
5. Biocompatibility (according to EN ISO 10993 standards)
EN 455-4:2009 Determination of shelf life
This standard is used to determine the expiration date, the date beyond which the glove can no longer be used while ensuring the integrity of its properties. The maximum lifespan of a medical glove is 5 years from the date of manufacture.