The use of disposable gloves in medicine is subject to various standards and regulations. One of these standards is EN 455. You will find the essential features below
Disposable gloves for use in medicine must meet the following requirements:
This first part of EN 455 defines the criteria for determining the freedom of holes of disposable gloves.
As part of this test, 1000 ml of water at a defined temperature are poured into the glove for up to 3 minutes.
As soon as this is completely filled, a water leak is checked in two phases. These tests are carried out immediately after filling and a second time within 3 minutes after filling.
As a result, the AQL value (Accepted Quality Level) is determined. This AQL must be 1.5 or better for medical disposable gloves.
This part defines the basic properties such as dimensions, tensile strength and marking. The test is carried out by taking a sample of at least 13 gloves per batch.
The dimensions of disposable gloves differ both in terms of size and purpose as non-sterile examination gloves or sterile surgical gloves.
Examination gloves are given in sizes XS, S, M, L, and XL.
In contrast, surgical gloves are given numerically in sizes from 5 to 9.5
The dimensions are always measured in the unstretched state. The length of a glove is defined from the lower edge to the tip of the middle finger. The width is measured in the middle of the thumb.
EN 455-2 defines a tear strength of at least 6.0N for examination gloves and of at least 9.0N for surgical gloves.
Infinitymed Nitrile examination gloves show e.g .: a tear strength of more than 20.0N and thus exceed the norm many times over.
The tensile strength test is also carried out here in 2 phases. The first phase is tested at room temperature, the second test is carried out with another set at 68-72 ° C.
An essential requirement of EN 455-2 is the labeling of every glove and / or packaging with the date of manufacture in accordance with ISO 15223-1 and EN 1041.