In the EU, all products defined as PPE (Personal Protective Equipment) are covered by the Council Directive 89/686 EEC, which is a Statutory Instrument. It is a mandatory requirement that the CE mark is affixed to all PPE provided all the appropriate elements of the Directive are satisfied. Without the CE mark, the product cannot be sold in the EU as PPE. The package itself can be marked if product marking is not appropriate.
Gloves of simple design, for minimal risks only.
Example of gloves in this category are household gloves. Additional gloves in this category can include light-duty gardening gloves or gloves for other work where the risk for injury is minimal. Manufacturers have the option to test and certify Category 1 gloves themselves.
Gloves that are neither simple nor complex in design.
Gloves are placed in this category when the risk is not classified as minimal or could not cause irreversible harm to health. Gloves in this category are typically general purpose that require good abrasion, cut or puncture resistance. The product is tested by an accredited laboratory and the results form part of a detailed Technical File for the product which is then submitted to a Notified Body. The Notified Body then issues the EC Type Examination Certificate that permits the use of the CE mark on the product.
Gloves of complex design, intended to protect against mortal danger or danger that may seriously and irreversibly damage health.
Gloves in this category are designed to protect against the highest levels of risk; e.g., highly corrosive acids. Gloves in this category must also be independently tested and certified by a Notified Body (appointed by the government in each member state), and the unique number of the Notified Body responsible for the ISO 9001 audit and 11B status is shown alongside the CE mark for the Category 3 product.
Simple Design or Category I products can be identified and marked by the manufacturer, and a Technical File is retained by the manufacturer.
Category II and III – Intermediate and Complex Design products are tested by external independent accredited laboratories and a test report is prepared. The test report forms part of a Technical File in which the details of product design, construction, specifications and information are included and how the appropriate Essential Health and Safety requirements of the Directive have been fulfilled.
The Technical File is submitted to a single Notified Body within the EU and the Notified Body issues an EC Type Examination Certificate that allows the use of the CE mark for these categories.
For Category 3 products there is an important additional element which requires assurance that the product quality is reliably maintained. This is done by a regular Notified Body Audit of the Quality System (Article 11B of the Directive) or by regular retesting of selected product by the Notified Body (Article 11A of the Directive). Such checks are carried out at least once each year.
All Ninja® manufacturing units have ISO 9001 Systems in place and therefore conform to Article 11B.
Notified Bodies are appointed by the government and are audited by a government-appointed assessment authority.
The Notified Body Number as shown above applies only to Category 3 products and is the Notified Body number which carried out the Quality Assessment as in Article 11.
The laboratory testing of glove products uses methods described in European Norms, or ENs, which are detailed in the following pages. These standards are under constant review by expert groups within CEN (translated as European Committee For Standardisation) and updated to expand the scope and take into account changes in method and materials. The issue date is indicated alongside the standard number; for example, EN 388:2003.
The EN standards are designed so that increasing levels of performance can be measured, and each EN has a unique pictogram beneath which the tested performance value in number or alphabet is displayed. The pictograms form part of the marking on the glove and are also used in publications, allowing easy access to product information and comparison. It should be noted that performance levels are determined by laboratory methods that cannot simulate actual end-use conditions. It is the responsibility of the user/employer to determine the risk in end use and the manufacturer such as Ninja® to provide sufficient information as enclosed, plus any other relevant information to enable the correct choice of glove to be made for the end use.
The CE mark is not a quality mark, but combined with the requirements of the Directive, external product testing and auditing of QA systems and certification it allows Ninja® customers to be assured that consistent and reliable product performance is maintained.
Although the CE mark and PPE Directive only have legal status within the EU, all the products manufactured by Ninja® are made under the same systems, and resulting product performance and the way the data is presented is recognised and appreciated throughout all the industrialised countries outside of the EU.