Here are some general considerations regarding regulations and standards for disposable gloves, including CPE gloves:

FDA (U.S. Food and Drug Administration):

In the United States, disposable gloves, including CPE gloves, are considered medical devices. The FDA regulates these products to ensure their safety and effectiveness. Manufacturers are required to comply with the FDA's Quality System Regulation (QSR) to maintain quality control in the manufacturing process.

ASTM International:

ASTM International (formerly known as the American Society for Testing and Materials) develops and publishes standards for various materials and products, including gloves. ASTM standards provide guidelines for testing and performance requirements. ASTM D5250 and ASTM D6978 are examples of standards related to evaluating the performance of disposable gloves.

ISO Standards:

The International Organization for Standardization (ISO) has developed standards related to the quality and performance of medical gloves. ISO 11193 specifies requirements for gloves made from natural rubber latex or synthetic rubber. Manufacturers may follow ISO standards to ensure their products meet international criteria.

CE Marking (European Conformity):

In Europe, disposable gloves are subject to the CE marking process, indicating compliance with European Union (EU) regulations. The European standard for medical gloves is EN 455, which includes requirements for dimensions, physical properties, and performance testing.

Health Canada:

Health Canada regulates medical devices, including disposable gloves, in Canada. Manufacturers are required to comply with the Medical Devices Regulations to ensure the safety and effectiveness of their products.

Good Manufacturing Practices (GMP):

GMP guidelines are often applicable to the manufacturing of medical devices, including disposable gloves. GMP ensures that manufacturing processes are controlled, and products consistently meet quality standards.

Manufacturers and distributors of disposable gloves are responsible for understanding and complyg with the specific regulations and standards applicable to their products in the regions where they are sold. Users of disposable gloves, such as healthcare professionals, should also be aware of and adhere to relevant safety guidelines and best practices.

It's recommended to check with local health authorities, regulatory agencies, and industry organizations for the latest information on regulations and standards related to disposable CPE gloves.