On what standards we test our single-use gloves

Testing disposable gloves based on EN455, ASTM D3578, and ISO 11193 involves a variety of different tests, each designed to evaluate different aspects of the gloves' performance. Here are some brief descriptions of the main tests involved in each standard:

EN455:

EN455 is a European standard that outlines the requirements and testing methods for disposable medical gloves. The standard consists of four parts, each covering different aspects of the gloves' performance. The specific testing standards for disposable gloves based on EN455 are:

*Freedom from holes: This test checks for holes or punctures in the gloves. The maximum allowable number of defects is 1.5% of the gloves in a batch.

*Physical properties: This test measures the strength and durability of the gloves, including tensile strength, elongation at break, and resistance to tearing. The minimum requirements for these properties vary depending on the type of glove.

*Shelf-life determination: This test assesses the stability and shelf-life of gloves by measuring the physical and chemical properties of the gloves over a period of time.

*Biocompatibility: This test assesses the potential toxicity or irritation of the gloves on human tissues. The gloves must meet specific requirements for the level of residual chemicals and microbial contamination.

ASTM D3578:

STM D3578 is a standard test method published by the American Society for Testing and Materials (ASTM) for evaluating the physical properties of rubber latex gloves. The standard outlines the requirements and testing methods for gloves that are intended for use in medical settings. The specific testing standards for latex gloves based on ASTM D3578 are:

*Tensile strength: This test measures the force required to break a glove specimen that is stretched at a constant speed. The minimum requirement for latex gloves is 18 MPa (megapascals).

*Elongation: This test measures the ability of a glove to stretch before breaking. The minimum requirement for latex gloves is 650%.

*Pinholes: This test is designed to detect holes or punctures in gloves. Gloves are filled with water, and any leaks or drops in pressure indicate the presence of a hole.

*Powder residue: This test measures the amount of powder on a glove's surface. The maximum allowable powder level is 2 milligrams per glove.

*Protein content: This test measures the amount of protein in a glove. Extractable antigenic protein content should be ≤ 10 µg/dm2；Aqueous soluble protein content should be ≤ 200 µg/dm2。

ISO 11193:

*Freedom from holes: This test is similar to the ones used in EN455 and ASTM D3578, filling the gloves with water and examining them for leaks or drops in water pressure.

*Physical properties: This test measures the gloves' tensile strength, elongation, and puncture resistance, similar to the tests used in EN455 and ASTM D3578.

*Dimensional testing: Dimensional testing involves measuring the length, width, and thickness of the gloves. This is important to ensure that the gloves fit properly and provide adequate protection.

*Biological evaluation: This test assesses the gloves' potential to cause allergic or toxic reactions in humans. It involves a variety of tests, including tests for cytotoxicity, sensitization, and irritation, as well as tests for bacterial endotoxins and bioburden.

We have collect a comparison table for more detail and specify explaination on different standard testing. Click here to download freely.

It's important to note that the specific testing methods and requirements may vary depending on the specific standard and the type of glove being tested. It is best to consult with our FITONE professional team to ensure that the gloves you need would meet the relevant standards.