Covers certain requirements for nitrile rubber gloves used in medical applications. Standard specifies various test methods including sterility testing, physical dimensions testing, physical requirements testing, powder residue, and powder limit testing.

EN 1186 - Food Safety. This regulation must be met for all gloves & equipment to be able to safely come into contact with food & limit the release of trace amounts of plastics. Overall migration limit (OML): max. number of non-volatile substances that can be released into food. Specific migration limit (SML): max. amount of metal that can be released into food.

Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

This International Standard is intended to facilitate global alignment of appropriate regulatory requirements for quality management systems applicable to organizations involved in one or more stages of the life cycle of a medical device. This International Standard includes some particular requirements for organizations involved in the life cycle of medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management system meets all the requirements of ISO 9001.

This specification covers certain requirements for natural rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers natural rubber gloves used in handling contaminated medical material.

Gloves designed to protect against intermediate risk, e.g., general handling gloves requiring good cut, puncture and abrasion performance, must be subjected to independent testing and certification by a notified body. Only these approved bodies may issue a CE mark, without which the gloves may not be sold. Each notified body has its own identification number. The name and address of the notified body that certifies the product has to appear on the instructions for use that will accompany the gloves.

AQL stands for "Acceptable Quality Level" and refers to an internationally used quality standard for measuring the % of pinhole leaks in disposable gloves. The test process involves checking batches of gloves during manufacturing to see how watertight they are. 1.5 AQL is the standard in the medical world. Gloves with an AQL of 4.0 are not suitable for medical use, they are for industrial and domestic use e.g., cleaning, garages, engineering, dirty factory jobs etc.

Goodpac is a cost-saving single glove dispensing technology, which prevents glove wastage and contamination. Gloves with defects are removed automatically, eliminating the human error element commonly encountered through conventional inspection and sorting methods.