INTCO EN ISO 455 Mode D'emploi page 3

EN – INSTRUCTION FOR USE
Instructions for use are to be used in combination with the specific product-related information on each product packaging. The gloves are sold as a bundled unit
with the shipping carton. In case products in the bundle are unbundled and sold separately, the distributor must ensure that the instructions for use are accompanied
with each separate unit.
The gloves are classified as Medical Device Regulation (MDR) Category I according to MDR Regulation (EU) 2017/745 and have been certified to comply with
this regulation based on the applicable harmonized European standards. The gloves meet the EN/ISO standards shown on each specific packaging. This MDR is for
single use only and to be disposed after contamination.
EXPLANATION OF THE STANDARDS AND PICTOGRAMS
EN 455 European Standard For Single Use Medical Gloves against Blood Penetration and Viruses
EN 455 Medical Gloves for Single Use covers any glove that could be used for medical work. The glove must adhere to four separate parts before it is considered
safe to be used for medical practice.
The four parts are:
EN 455-1: Requirements and testing of gloves for freedom from holes
EN 455-2: Requirements and testing of gloves for physical properties
EN 455-3: Requirements and testing of gloves for biological evaluation
EN 455-4: Requirements and testing of gloves for shelf life determination
Between them they ensure that the glove will be a barrier against micro-organisms, perform effectively without breaking, protect the user from toxic and hazardous
materials, and lastly how long a glove will be fit for use.
Abbreviation for acceptable quality limit. AQL
refers to the quality level that is the worst tolerable
process average when a continuing series of lots is
submitted for acceptance sampling. At AQL
sampling, when the same number of products are
sampled, the smaller the value of AQL, the smaller
the number of defects allowed.
The CE mark indicates the good's conformity with
safety, health, environmental protection, consumer
protection, etc. as required by a series of EU
directives.
PRECAUTIONS FOR USE
Before use, always check the gloves for possible mechanical damage, e.g. holes or tears. Do not use damaged gloves.
Select gloves with a length appropriate for you, as the risk to the wrist area is minimal
Donning & doffing gloves in a proper way is a skill that needs to be practiced by healthcare workers or others that use
gloves. Donning must be performed in the correct order to prevent transmission of infections. Keep hands clean before
donning gloves. When removing the gloves, avoid the contact of gloves' outer surface with your skin, because the surface
may have been contaminated with blood or other body fluids. Avoid snagging, as this may cause contaminants to splash into
your eyes or mouth or onto your skin or other people nearby.
TEMPERATURE DELIMITATION
Intco Medical I 12/2021
Gloves for single use compliant with MDR regulation (EU) 2017/745 and EN ISO 455
STORAGE INSTRUCTIONS
The storage area should be cool, dry, and dust-
free. Protect gloves from UV light sources,
sunlight, oxidizing agents, and ozone. Store in
the original packaging according to the
temperature limits indicated on the packaging.
Gloves for single-use only and non-reusable.
EU CE Marking for Machinery Directive
Protect from
moisture.
This is a non-sterile product.
INGREDIENTS / HAZARDOUS
COMPONENTS
Certain gloves may contain
ingredients known to cause skin
irritation or allergic reactions in
sensitive individuals. Check the
warnings on the specific packaging.
Formulation will be shared upon
request.
DISPOSAL INSTRUCTIONS
Dispose of gloves according to the valid regulations for the
glove material. Gloves contaminated by chemical substances
must be disposed of in accordance with the regulations for the
chemicals concerned.
Protect from sunlight.
3 / 29