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Developed by the American Testing and Materials Association (ASTM), the ASTM 3578-19 standard includes test methods for evaluating the performance and safety of natural rubber gloves used in medical examinations and diagnostic and treatment procedures. This standard also covers natural rubber gloves used in the handling of contaminated medical equipment. The full name of this standard is as follows: ASTM D3578-19 Standard specification for rubber examination gloves.
The specification includes both hand-fit gloves, pair gloves and natural rubber gloves. It also includes packaged sterile natural rubber gloves and packaged or bulk non-sterile natural rubber gloves.
The ASTM 3578-19 standard is designed as a reference to the performance and safety of natural rubber examination gloves. The safe and correct use of natural rubber examination gloves is not covered by this specification.
The material under this specification consists of type I and type II gloves made of any natural rubber compound, without talc on the inner and outer surfaces of the gloves, and with dimensions and physical properties suitable for the specified conditions. In order to evaluate the compliance of rubber gloves with the requirements, tests such as sterility, non-puncture, physical dimensions, tensile strength, ultimate elongation, stress in elongation, powder-free residue, powder amount, protein content and antigenic protein content must be performed.
This standard describes the size, tolerance, and physical requirements for latex examination gloves. By testing the tensile strength and elongation of the material, it is determined that it can stretch as well as an examination glove. The ASTM D3578 standard states that the acceptable quality limit of latex examination gloves should be 2,5, a minimum tensile strength of 18 MPa and a minimum elongation rate of 700 percent.
Medical gloves are classified as Class II devices. This is because the gloves are made of latex, vinyl, synthetic polymer or nitrile, or are not sterile or sterile. For example, disposable, non-sterile, polyethylene gloves found in first aid kits are medical gloves. Bunlawr protects both the patient and the user.
With the experience gained over many years, our organization also provides standard specification testing services for ASTM D3578-19 rubber examination gloves, within the framework of laboratory services of materials with a trained and expert staff, to the demanding enterprises.
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