The implementation standards for plastic gloves mainly include international, Chinese, EU and US implementation standards. 1
International standards:
ISO 10282:2017: This is the standard for disposable non-sterile gloves formulated by the International Organization for Standardization (ISO), which is applicable to gloves made of various materials including PVC gloves. The standard specifies the physical, chemical and biological performance requirements of gloves, as well as test methods.
Chinese standards:
GB 10213-2006: This is the Chinese national standard that specifies the technical requirements, test methods, inspection rules, marking, packaging, transportation and storage of disposable polyvinyl chloride gloves. This standard applies to PVC gloves for medical and non-medical purposes.
GB/T 24786.3-2009: This is another part of the Chinese national standard, which is specifically for the microbial limit standard of disposable polyvinyl chloride gloves.
EU Standards:
EN 455-1:2016: This is a standard developed by the European Committee for Standardization (CEN) that specifies requirements and test methods for single-use non-sterile gloves, including PVC gloves.
EN 455-2:2016: This standard is a supplement to EN 455-1 and provides a classification system for gloves to help users choose the right gloves.
US Standards:
FDA 510(k): The U.S. Food and Drug Administration (FDA) requires that all medical devices, including PVC gloves, must go through the 510(k) approval process to demonstrate their safety and effectiveness.
ASTM D6319: This is a standard for single-use gloves developed by ASTM, including physical property requirements for PVC gloves.
These standards generally include the following main contents:
Materials and Manufacturing: Specifies the material composition and manufacturing process of gloves to ensure the quality and consistency of gloves.
Physical Properties: Includes tensile strength, puncture resistance, chemical resistance, etc. to ensure the durability and protection of gloves during use.
Microbial Limits: Gloves must meet microbial limit requirements to prevent cross contamination.