LEGISLATIVE and normative regulations

On the European level, Personal Protective Equipment (PPE) is governed by the Directive 89/686/CEE, which classifies it depending on the risks covered :

• category 1 : minor risks,
• category II : intermediary risks,
• category III : major risks (mortal risks).

For each category, the directive defines the procedures to be adopted for product certification and thus allows for the affixing of the "CE "mark,

For category III (in which our insulating glove range for live working is classed), the directive provides for :

• product certification by a notified body who delivers the EC type examination certificates,
• the setting up of a manufacture monitoring system, either through an EC quality control system for the final product (procedure 11 a), or through a system for ensuring EC quality of production by means of monitoring (procedure 11 b),

REGELTEX has chosen the second solution with the establishment of a quality management system ISO 9001, certified and verified annually by "AFAQ-AFNOR Certification", the notified body by the European Commission for monitoring procedure 11b.

The European directive provides a legislative framework for the free distribution of PPE in Europe, Compliance with harmonised European standards (EN) proves conformity with this directive.

Our products meet the specifications described in the standard EN 60903:2003 and in the IEC international standard IEC 60903:2002 which specify the performances of gloves of insulating material for live working.

Electrician gloves take 29 days to manufacture

STAGE 1 - Receipt and preparation of raw materials  - 4 days

• Quantitative and qualitative inspections of raw materials : for each latex delivery, samples are sent to an external laboratory for acceptance on the basis of criteria that are more restricting than the standards in force,
• Micronisation of solids for optimum dispersion in the latex base.

STAGE 2 - Production - 2 days

• Systematic acid c1eaning of porcelain forms,
• Daily verification of manufacturing parameters (pH, density, hygrometry, conductivity, etc.),
• Dipping procedure: from 45 minutes to 4 hours depending on the class of gloves to be produced.

STAGE 3 - Validation of production batches  - 21 days

ln accordance with the normative requirements, each production batch must be validated in order to be marketed. This validation involves the implementation of the aforementioned tests : it may consist in the sampling of 200 gloves for one batch and require two people to be working full time.

STAGE 4 - Handling orders  - 3 days

Orders are integrated into the production timetable and started with the electrical test to the proof voltage, which completes the production process of the insulating gloves and allows for the application of the following stages :

• Cut,
• Marking,
• Sealed packaging.

All the manufacturing and inspection stages are documented by means of instruction in accordance with the quality management system ISO 9001:2000 in place.