Packaging shall be sized so that no unnecessary packaging material us used and shall meet the requirements in Council Directive 94/62/EC on packaging and packaging waste.
- No packaging material shall contain PVC.
- Sterile medical
- Surgical gloves: The material used for the secondary packaging shall be a triple-layer sterile barrier system, with gloves individually packaged in sterile packaging bags in accordance with ISO 11607-1:2019/Amd 1:2023 (Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems) or the equivalent.
- The secondary packaging shall show information about the glove material, number of gloves contained and glove size, and secondary packaging shall be available in different sizes (from 100 pairs of gloves per secondary packaging). Marking with symbols on the primary and secondary packaging for sterile gloves (a sterile packaging bag for each pair of gloves) in accordance with EN ISO 15223-1 for medical gloves and EN 21420 for laboratory gloves, see the Marking and information that must be provided with medical gloves for single use and Marking of laboratory gloves with personal protection from chemicals attachments.
