Polyco - Explanation of Standards

Explanation of Standards

Mechanical Hazards EN388 Rating a) Resistance to abrasion 0-4 b) Blade cut resistance 0-5 c) Tear resistance 0-4 d) Puncture resistance 0-4

Medical Devices Directive Medical Devices Directive 93/42/EEC classifies devices according to the potential hazard, expected duration of contact and expected invasiveness. If a product conforms to the Medical Devices Directive it must carry a CE mark on its packaging, and may also provide a statement of its classification. In addition, the properties of medical devices are described by a range of standards.

abcd

Chemical and Micro-Organism EN374 Rating EN374-2 Resistance to penetration by 1-3 micro-organisms. Referred to as acceptance quality limit (AQL)

Classification of Devices Class I

Non-invasive devices, for example examination gloves (entry into a bodily orifice is not considered invasive). Sterilised class I devices, for example sterile procedure gloves. With respect to the portfolio of Polyco Healthcare products these are short term invasive devices, for example surgical gloves.

Class I - Sterile

EN374-3 Resistance to chemical hazards

1-6

Class IIa

Thermal Hazards (Heat and/or Fire) EN407 Rating a) Burning behaviour 0-4 b) Contact heat 0-4 c) Convection heat 0-4 d) Radiant heat 0-4 e) Small splashes of molten metal 0-4 f) Large splashes of molten metal 0-4

European Standards for Medical Gloves All Polyco Medical Gloves comply with the European Standard EN455 Medical Gloves for Single Use. The standard is divided into 4 parts covering: EN455-1 – Freedom from holes. EN455-2 – Physical properties. EN455-3 – Requirements for biocompatibility and labelling. EN455-4 – Requirements and testing for shelf life determination. For Minimal Risks Only Gloves of simple design offer protection from low level risks, e.g. janitorial gloves. Manufacturers are permitted to test and self-certify the gloves themselves.

abcdef

Protection from Cold EN511

Rating

a) b) c)

Resistance to convection cold Resistance to contact cold

0-4 0-4

abc

Permeability to water

0-1

Anti-Static EN1149 Protective Clothing - Electrostatic Properties

Gloves of this category are CE-marked as follows:

EN1149-1 Protective clothing - electrostatic properties. Part 1: test method for measurement of surface resistivity. This is resistance in ohms ( 1 ) along the surface of the material. EN1149-3 Protective clothing - electrostatic properties. Part 3: testmethods formeasurement of charge decay. EN1149-5 Protective clothing - electrostatic properties. Material performance and design requirements. Gives the pass requirements as 2.5 x 10 9 ( 1 ) (for part 1) and t 50 < 4s or S >0.2 (for part 3). t 50 is the half decay time and S is the shielding factor. You can use either part 1 or part 3 to pass. Food Contact Product is made from food approved ingredients. Migration testing is performed to ensure that the article in contact with food meets the required standards. If both of these criteria are met, the Food Contact symbol can be applied to the glove and/or packaging. Dyneema ® Technology Applying Dyneema ® Technology in a lightweight glove can boost cut performance levels. It requires no compromise on comfort, tactility and weight of the glove, while providing significantly higher cut resistant performance and better durability. For heavy duty applications, combining Dyneema ® Technology with glass fibre or steel wire will boost performance levels even further. Puncture Resistance (EN388) Puncture resistance is measured as the force required to break through samples from gloves with a standard puncture needle. The design of this needle is comparable to that of a large nail. Performance Level 1 2 3 4 Puncture Force (N) 20 60 100 150 Needlestick Resistance To assess resistance from puncture by a needlestick, a 25 gauge hypodermic needle can be used. Dyneema ® is a registered trademark of Royal DSM N.V.

For Minimal Risks Only

The higher the score, the better the performance. 0 represents a fail - X denotes no test was carried out.

Notified Body Number (Only used if the glove is Cat III/Complex Design)

CE Symbol

Relevant Pictograms

EN388 Scores

Polyco Industrial Logotype

Product Name Polyco Reference Code Size of Glove

Quality at the forefront Our goal is to meet and exceed customer expectations. To ensure the highest level of quality our products are subject to one of the most rigorous Quality Assurance regimes in the glove industry. To support this Polyco operates a Quality Management System that is externally certified to ISO 9001 and ISO 13485. We are committed to maintaining the highest levels of product quality, customer service and ethical standards, whilst minimising our impact on the environment. Our Environmental Management System is certified to ISO 14001 to allow us to continually assess and improve our environmental performance.

5