Pinhole defects (AQL) for disposable gloves

Check that the supplier provides information verifying that the products have been manufactured in accordance with the stated standards and have been tested with the specified methods according to EN 455 or EN 374.

If a verified self-declaration is used to prove that the requirement is fulfilled, request the supplier’s self-declaration, including documentation showing that the requirement is met. The self-declaration shall be verified by a verification body accredited for the task in accordance with ISO / IEC 17029 or equivalent standard.

The gloves shall be produced, and their quality assured in accordance with the requirements set in the 455 standard, which specifies requirements and testing methods for medical gloves for single use (455-1, 455-2, 455-3 and 455-4).

Apart from pinhole defects, it is important that gloves are not in danger of breaking when they are put on, which is a risk for both the wearer/user and the patient. It is therefore important that gloves have the strength/durability specified in the EN 455-2 standard. The sizes of the gloves shall also lie within the required levels stated in EN 455-2. It is important that the gloves comply with EN 455-3 and are evaluated as to their effect on the wearer/user. In order to ensure that gloves are safe across their entire shelf life, it is important that they are tested according to the EN 455-4 standard.

There are currently a limited number of accredited verification bodies for ISO/IEC 17029 (Conformity assessment - General principles and requirements for validation and verification bodies) as it is a relatively new standard. This may change, especially if the demand for verifying compliance in this way increases. More information about the standard and accredited verification bodies can be found on Swedac's website.

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