UK CA Mark

When the UK withdrew from the EU on 31^st December 2020 (BREXIT), it left behind the EU’s compliance system the CE mark. In order to ensure that products were being put onto the market with the highest of standards, the UK has adopted a UK CA Mark.

The UKCA (UK Conformity Assessed) product marking is a new system, which is used for goods being placed on the market in Great Britain (England, Wales and Scotland). The defined product types that CE marking applied to will require the new UK CA mark to sell in the UK.

Process

The Conformity process for products such as PPE and Medical Devices remains similar to the CE marking, but must ensure that it is correct for the UK. EU Notified bodies can no longer be used, and so UK based Approved bodies should be selected. There is also a requirement for a separate UK version of the Declaration of Conformity.

Timeline

To ensure that industry had time to act on this new regime, the UK government has allowed a implementation deadline of 1^st January 2022 for most products, and longer for Medical Devices. During that time product manufactured with a CE mark will be allowed to be sold.

UK & EU products

Products sold in both the UK and the EU will have to ensure product is labelled with both the CE and the UK CA Mark.

Rules for using the UK CA mark

There are rules set for the clarity and sizing of the mark, ensuring that consumers interests are maintained. 

• You must ensure that the letters remain in proportion to the official lettering version
• UK CA marking should be at least 5mm in height – unless otherwise required by product legislation
• UK should be easily visible 
• From 1^st January 2023, it should be permanently attached

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EN ISO 21420:2020

EN ISO 21420:2020 General standards for protective gloves 

BS EN 420 has been reviewed and replaced by a new standard EN ISO 21420:2020 ‘Protective gloves – General requirements and test methods’. As it is a ISO standard, this is now a Worldwide standard.

Scope

The requirements of the new standard cover all protective gloves; such as protective gloves; arm protectors; gloves fitted to containment enclosures, mittens and pot holders.

Application

As the PPE Regulation states, products must be ‘state-of-the-art’. Protective gloves will need to be tested in accordance with EN ISO 21420. This should be done in time for any new EU type-examination applications.

The standard focuses on key product safety and performance issues such as: 

• Innocuousness
• Size
• Dexterity
• Package marking
• Instructions for use

Key points from the new EN ISO 21420 standard:

General

The design and manufacture of gloves should ensure the product provides protection when used in accordance with manufacturer’s instructions, without harm to the end user.

Innocuousness

With the aim that protective gloves shall not adversely affect health, safety and hygiene of the end user, changes were made to the standard. This creates a greater alignment of Chemical testing with REACh Requirements. Key points that we should be aware of are:

• Any metallic materials that could come into contact with the skin shall not release nickel in more than 0.5µg/cm2 per week (Test method EN 1811)
• DMFa (dimethylformamide) shall not exceed 0.1% weight/weight (Test method prEN 16778)

Size

The standard has removed the requirement of minimal glove length requirements, unless required by a specific standard.

Product Labelling

Product labelling should include a date of manufacture markings, and improved information for users, additional information on donning/doffing, and advice on product integrity checks before use.

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BS EN 455 – European Standard for Medical Gloves

In order for a product to be used in a medical environment, it is essential that the product meets the tough requirements of the EN 455 test.

BS EN 455-1: 2020 Freedom from holes. 

Testing for this standard uses a water leak test that is carried out using AQL statistical sampling techniques based on production batch sizes. Gloves used in a medical setting require an AQL of 1.5, which is a maximum of 1.5% product failure.

This is important in the real world, as this helps to reassure users that the gloves are thoroughly checked for holes, providing an effective barrier from exposure to chemicals or biological contaminants, when they need protection.  

BS EN 455-2: 2015 Physical Properties. 

This covers testing such as dimensions (length & width) and force at break both before and after heat ageing.

This testing ensures that Gloves conform with uniform sizing specifications, so that the correct size can be selected by the user. The force at break is important to ensure that gloves are strong enough for their appropriate use, and that users can don and use the gloves with confidence. Whilst the actual physical testing requirements of the glove depend on the specification and material that the glove is made of, this testing ensures the user receives good quality product. 

BS EN 455-3: 2015 Biological evaluation. 

Biological evaluation of endotoxins, powder residue and leachable proteins is important in safeguarding the user’s skin health during use. Endotoxins is a measure of chemicals left by harmful bacteria, and is important to surgical gloves. 

Powder free gloves should ensure less than 2mg powder per glove, to ensure that the glove is suitable for that claim.

Measurement of leachable proteins is relevant for Natural Latex products, which have natural proteins and enzymes, where it is well documented that susceptible individuals may have allergic skin reactions during use of the gloves. 

Chemical residue testing, commonly using ISO10993, ensures that users skin is not exposed to harmful chemicals during wearing of the glove. Chemicals can cause skin reactions and dermatitis (Type IV allergic reactions) in susceptible individuals.

BS EN 455-4: 2009 Requirements and testing for shelf-life determination.

It is important to test the shelf life of products, so that an effective expiry date can be given. This gives users confidence that the glove will be of good quality whilst in date. 

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For further help, or information contact your local Supermax Sales Manager, or e-mail This email address is being protected from spambots. You need JavaScript enabled to view it.. For Quality, Regulatory and technical issues contact This email address is being protected from spambots. You need JavaScript enabled to view it.