Serious hygiene issues in the field of rubber are summarized in this review article. We look at latex allergy issue and nitrosamine issue that have occurred in the past as serious hygiene issues of rubber products, while keeping in mind that saving a human life is a true proposition as a superordinate concept that must be prioritized above all. We reaffirm that new technologies must be developed based on new concepts to solve these issues and understand a significant importance of developing protein-free natural rubber and nitrosamine-free vulcanization accelerators. We recognize that hygiene issues are usually avoided by laws and regulations such as the positive list system since developments of new technologies based on new concepts are exceedingly difficult. We also look at a progress status of preparation of the “5th edition of the positive list regarding rubber food utensils, containers and packagings”. Consequently, one may understand the activities and importance of the Research Subcommittee on Hygiene Issues of the Society of Rubber Science and Technology, Japan, which conducts research on the hygiene issues in the field of rubber.

Rubber products such as gloves and masks are indispensable in a medical workplace etc., where hygienic measures are required. However, rubber products sometimes cause health problems such as allergic disorders. Allergies caused by rubber products include immediate-type latex allergy and delayed-type allergic contact dermatitis. In particular, chemicals deliberately added in working processes of rubbers such as vulcanization accelerator sometimes cause allergic contact dermatitis, so it is very important to evaluate their allergic potentials by skin sensitization tests. Although animal tests have been the mainstream for skin sensitization tests for a long time, non-animal alternative test methods are becoming mainstream for animal welfare reasons. This review describes the latest trends of skin sensitization test methods.

Natural rubber latex is widely used in medical gloves. However, it contains allergen proteins that cause symptoms such as urticaria. This article reviews the quality-control factor of deproteinized natural rubber latex, which is commercially produced by enzyme-centrifugation method.

In this review, rubber components for medical devices, especially disposable (single-use) devices, are explained. Synthetic rubbers have been developed since World War II. They are used even in various medical devices. However, its scope of application is limited, most synthetic rubber components are used only for applications that do not come into direct contact with biological tissue, or even come into contact with, only skin and mucous membranes.

Disposable medical devices have been also developed rapidly since the 1950s, and adopted a large number of synthetic rubber components that take advantage of their flexibility, elasticity, and resealability after removing the pierced needle. Chemical and biological evaluation should be carried out to prove the safety of medical devices, recently, the demand for E & L (extractable and reachable) testing at the component level is increasing.

Rubber materials are frequently used as closures for containers, because of their good sealing properties. As for such closures intended to be used for containers for medical agent, there are regulations regarding protection, compatibility, safety, and functionality. This article briefly describes such regulations of Japanese pharmacopoeia and related information of other pharmacopoeia and ISO standards.