EUROPEAN DIRECTIVE 93/42/EEC Covering medical examination and surgical gloves
EN 455-1 Freedom from holes
EN 455-2 Physical properties
EN 455-3 Biological evaluation
EN 455-4 Shelf life determination
A random sample of gloves is tested for freedom of holes by undergoing a water leak penetration test. The gloves are filled with 1l of water and must remain completely leak proof over a defined period of time. A failed test results in a higher AQL value, which for medical gloves sold in Europe must be 1,5 or lower.
AQL (accepted quality level) is a quality sampling procedure ISO 2859-1 used by manufacturers for measuring the % likelihood of pinhole defects in a batch of single use gloves. An AQL of 1,5 brings a statistical probability that less than 1,5% of the gloves in the batch will have defects.
Size and tensile strength requirements for single use medical gloves. No less than 240mm in median length and 95mm (±10mm) median width to provide adequate protection along full length of the hand (exception for long cuff gloves).
Strength is measured by elongation until breaking point, indicated as Force At Break (FAB) in newtons (N). FAB is measured on standard sample and on a rapid aged sample that is kept at 70°C for 7 days to simulate glove deterioration during prolonged shelf life. FAB requirements differ per glove material and if the glove is for examination or surgical purpose. Indication of median minimum FAB values:
A number of important requirements are specified to maintain biological safety of the glove for the medical practitioner as well as the patient. LATEX pictogram on packaging for natural latex rubber gloves is mandatory. No terms suggesting relative safety of usage are permitted i.e. low allergenicity, hypoallergenicity or low protein content. Powder residue, which is seen as unwanted contaminant on medical gloves, must not exceed 2mg per glove with powder-free claim. Water extractable latex protein content in latex gloves must not exceed 50 microgram per gram of rubber to minimize latex exposure that can cause allergic reactions. The level of endotoxins generated by bacteria on sterile gloves that claim low endotoxin level may not exceed 20 EU per glove pair (EU=Endotoxin Units).
The standard ensures there is no performance degradation during storage period prior to use. Accelerated aging tests are performed on glove samples to determine shelf life, to enable manufacturers to prove that their product will withstand (usually) up to 3 years and in some cases up to 5 years without losing their strength and protection properties.
EN 1149-1 Antistatic properties
RISKS RELATED TO FOOD CONTACT
Tested level of glove surface resistivity. Measured in ohms/square (Ω), this indicates the capacity of the glove to disperse via a dissipative and/or conductive effect the accumulated static electricity discharges on the operator s hand.
It is applied to materials and articles that, at finished state, are intended to come into contact or are brought into contact with foodstuffs or with water that is for human consumption. According to Regulation 1935/2004: «The materials and articles must be manufactured in accordance with good manufacturing practice so that, under normal or foreseeable conditions for their use, they do not transfer their constituents to food in quantities which could:
Present a danger to human health,
Results in an unacceptable change in the composition of the foodstuffs or a deterioration in the organoleptic characteristics thereof.»
All SHOWA gloves with the «food contact» logo are conform to Regulation (EU) No 1935/2004 and the Regulation (EU) No 2023/2006.
Force at break (N) during shelf life
Rubbers (e.g. natural latex, nitrile)
Thermoplastics (e.g. PVC, vinyl, butyl)
Examination glove ≥ 6,0 ≥ 3,6 Surgical glove ≥ 9,0 -
IA L S