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February 2022, Rev. 2.1
INSTRUCTION FOR USE OF PERSONAL PROTECTIVE EQUIPMENT
nitrylex® classic
RD30019001-05; RD30096001-05; RD30174001-05; RD30143001-05;
RD30097001-05; RD30169001-05; RD30168001-05
The instruction below should be used in conjunction with detailed information on the packaging.
Short description of the product
Examination and protective gloves, nitrile, powder-free, for single use, nonsterile
Full description of the product
Reference number
Raw material
Cuff
Colour
Shape
Size range
AQL
Quantity in packaging
Shelf life
: RD30019001-05; RD30096001-05;
RD30174001-05; RD30143001-05; RD30097001-05;
RD30169001-05; RD30168001-05
: nitrile
: beaded
: blue/white/violet
: ambidextrous, fitting to the right and left hand
: XS (5-6), S (6-7), M (7-8), L (8-9), XL (9-10)
: 1.0
: 50/100/200 pcs. by weight
: 3 years (from the date of manufacturing)
Storage instructions
It is recommended to store the gloves in dry place, in the temperature of
5-35°C and to protect them against direct sunlight.
Keep the gloves in a distance of not less than 1m from heating devices, sources
of fire and ozone.
Do not keep in direct vicinity of solvents, oils, fuels and lubricants.
Food contact
Gloves are marked with food contact symbol and comply with
the requirements of Regulation (EU) No 10/2011, European Regulation (EC)
No 1935/2004 and with Regulation (EC) No 2023/2006 on Good Manufacturing
Practice. Gloves are suitable for handling the food and have been tested for
Overall Migration Test acc. EN 1186:
Extraction conditions
(tested for 2 h in 40°C)
Analysis results
[mg/dm2]
Test Result
(limit < 10 mg/dm2)
10% Ethanol
Not detected (<1.0)
Pass
3% Acetic acid
3.4
Pass
Olive oil
5.9
Pass
MD classification & compliance
Gloves are classified as class I according to Annex VIII of the Regulation (EU)
2017/745 and comply to standards:
EN 455-1:2020, EN 455-2:2015, EN 455-3:2015, EN 455-4:2009,
EN ISO 15223-1:2021, EN 1041:2008+A1:2013.
PPE classification & compliance
Gloves are category III Personal Protective Equipment as per Annex I of
the Regulation 2016/425 and comply to standards:
EN 420:2003+A1:2009, EN ISO 374-1:2016, EN ISO 374-2:2019,
EN 16523-1:2015+A1:2018, EN 374-4:2013, EN ISO 374-5:2016.
EU Type Examination (Module B) and on-going conformity (Module C2) Notified
Body:
Satra Technology Europe Ltd
Bracetown Business Park,
Clonee, Dublin 15,
Dublin, Ireland
Declaration of Conformity and this instruction for use available under below
web address:
https://mercatormedical.eu
Intended use
These are non-sterile examination and protective gloves for single use, intended
for use in medical field to: protect patient and user from cross- contamination,
conducting medical examinations, diagnostic and therapeutic procedures and
for handling medical contaminated material. Gloves are classified as Medical
Devices Class I and as a Personal Protective Equipment Category III, type B.
Gloves designed to protect against substances and mixtures which are
hazardous to health and against harmful biological agents. Gloves designed to
protect against to chemical risk according with EN ISO 374-1:2016 and
microorganism (viruses, bacteria and fungi) risks according with
EN ISO 374-5:2016. Their design and labelling corresponds to the requirements
of the European Regulation 2017/745 on Medical Device and the European
Regulation 2016/425 on Personal Protective Equipment. Gloves should be used
solely according to their intended application.
Precautions and indications for use
Dry hands before taking the gloves out from the packaging. Before usage, inspect
the gloves for any defect or imperfections. Use at least 1 pair of gloves for one
patient and one procedure, these are disposable gloves. Do not let chemical
substances get under the gloves through the cuff. If a chemical substance
reaches the skin, wash it away immediately with plenty of water. If the gloves
get punctured, torn or broken during their use, take them off and put on the
new ones. Avoid using gloves dirty in the inside as they may cause irritation
leading to skin inflammation or more serious damages.
It is recommended to check that the gloves are suitable for the intended use
because the conditions at the workplace may differ from the type test depending
on the temperature, abrasion and degradation. The gloves should not be used
in contact with open fire and to protect against any sharp tools. The gloves are
not intended for welding, electric shock protection, ionizing radiation or from
the effect of hot or cold objects.
The chemical resistance has been assessed under laboratory conditions from
samples taken from the palm only (except in case where glove is equal to or over
400 mm – where the cuff is tested also) and relates only to the chemical tested.
It can be different if the chemical is used in a mixture. This information does not
reflect the actual duration of protection in the workplace and the differentiation
between mixtures and pure chemicals.
When used, protective gloves may provide less resistance to the dangerous
chemical due to changes in physical properties. Movements, snagging, rubbing,
degradation caused by the chemical contact etc. may reduce the actual use time
significantly. For corrosive chemicals, degradation can be the most important
factor to consider in selection of chemical resistant gloves.
Gloves are suitable for special purposes as they are examination gloves where
risk of wrist injury caused by chemicals is considered to be minimal. Length
suitable for tasks that require hand protection. Gloves shorter than minimum
lengths required by EN 420 standard. Glove minimum length in accordance to
EN 455-2 standard.
Components / hazardous components
Components used in making gloves may cause allergic reactions in some people.
Some gloves may contain components known to be a possible cause of allergy
for person allergic to them, who may develop contact irritation and/or allergic
reaction. In case of an allergic reaction consult a doctor.
Disposal
Used gloves should be treated as a contaminated material, therefore local
regulations regarding the disposal of such materials should be applied.
Manufacturer
MERCATOR MEDICAL S.A.
ul. H. Modrzejewskiej 30
31-327 Cracow, Poland
www.mercatormedical.eu
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February 2022, Rev. 2.1
Permeation performance levels as per EN ISO 374-1:2016
• Level 1 > 10 min • Level 2 > 30 min • Level 3 > 60 min • Level 4 > 120 min • Level 5 > 240 min • Level 6 > 480 min
Test results acc. to EN 16523-1:2015+A1:2018
EN 374-4:2013
Degradation [%]
Test results acc. to EN 16523-1:2015+A1:2018
EN 374-4:2013
Degradation [%]
Chemical
Level
Chemical
Level
*4% Chlorhexidine Digluconate
6
19.0
30% Hydrogen Peroxide (P)
2
22.8
40% Sodium Hydroxide (K)
6
-42.9
1.5% Methanol in water
6
21.9
10-13% Sodium Hypochlorite
6
14.7
25% Ammonium Hydroxide (O)
1
-52.0
50% Sulphuric Acid
6
-20.5
3% Povidione-iodine
6
33.7
65% Nitric Acid
0
97.6
99% Acetic Acid
0
93.9
10% Acetic Acid
4
66.7
10% Sodium Percarbonate
6
15.4
5% Ethidium Bromide
6
3.4
50% Glutaraldehyde
6
27.4
37% Formaldehyde (T)
3
5.0
0.1% Phenol
6
33.8
70% Isopropanol
0
62.2
35% Ethanol
0
38.8
*Permeation rate 7µg/cm2/min
EN 374-4: 2013 Degradation levels indicate the change in puncture resistance of the gloves after exposure to the challenge chemical.
Test acc. to EN ISO 374-2:2019 – Level 2 (ISO 2859)
Test acc. to EN ISO 374-5:2016
Performance level
AQL
Protection against bacteria & fungi
Pass
Level 3
< 0.65
Protection against viruses
Pass
Level 2
<1.5
EN ISO 374-5:2016 The penetration resistance has been assessed under
laboratory conditions and relates only to the tested specimen.
Level 1
< 4.0
Symbols used on the packaging
Medical Device
Keep dry
Nitrile gloves
Personal Protective
Equipment
Keep away from sunlight
Powder-free gloves
Manufacturer
Temperature limitation
5-35°C
For single use only
Lot / batch number
Keep away from ozone
Non-sterile
Catalogue number
Product quality is not
ensured if the package is
damaged
Designed to protect
against to chemical risks
acc. with EN ISO 374-1
(type B)
Expiry date
Recyclable packaging
Designed to protect
against microorganisms
risks acc. with EN ISO
374-5
Date of manufacture
Package can be treated
as municipal waste
Consult instructions for
use
Indicates compliance
with the requirements of
Ukrainian market
Suitable for food contact
(for details check the
instruction for use)
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February 2022, Rev. 2.1
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