This standard specifies the technical requirements for sterile-packed rubber gloves used to prevent cross-infection between patients and users during surgical operations. Suitable for single-use gloves that are donned once and then discarded. Not suitable for examination gloves or a range of operating gloves. It includes gloves with a smooth surface and partially or fully textured gloves. This standard specifies the performance and safety of rubber surgical gloves. However, the safe and correct use and sterilization process of surgical gloves and subsequent handling, packaging and storage processes are outside the scope of this standard.
GB/T 7543-2020 Referenced Document
ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
ISO 15223 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied; Amendment 2
ISO 188 Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests*, 2023-03-09 Update
ISO 23529 Rubber - General procedures for preparing and conditioning test pieces for physical test methods
ISO 28591 Sequential sampling plans for inspection by attributes
ISO 37 Rubber, vulcanized or thermoplastic - Determination of tensile stress-strain properties