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February 2022, Rev. 2.2
INSTRUCTION FOR USE OF PERSONAL PROTECTIVE EQUIPMENT
dermagel® coated
RD10006001-05
The instruction below should be used in conjunction with detailed information on the packaging.
Short description of the product
Examination and protective gloves, latex, 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
: RD10006001-05
: natural rubber latex
: beaded
: creamy
: 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
: 100 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, except for acidic foods, 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)
3% Acetic acid
49.5
Failed
10% Ethanol
3.2
Pass
Olive oil
Not detected (< 3.0)
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.
Notified Body responsible for EU Type Examination (Module B) and on-going
conformity (Module C2):
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
Product contains natural rubber latex which may cause allergic reactions including
anaphylactic responses. 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. 2.2
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
1.5% Methanol
6
6.1
50% Sulphuric Acid
6
-22.1
10% Acetic Acid
1
-1.4
5% Ethidium Bromide
6
-24.7
50% Benzalkonium Chloride*
2
-10.7
3% Hydrogen Peroxide
6
-2.6
4% Chlorhexidine Digluconate**
6
-13.1
30% Hydrogen Peroxide (P)
2
4.3
10% Phosphoric Acid
6
-18.4
37% Formaldehyde (T)
5
-23.6
40% Sodium Hydroxide (K)
4
-59.2
5% Glutaraldehyde
6
-8.9
12% Sodium Hypochlorite
6
-25.4
0.1% Phenol
6
-32.7
*minimum detectable permeation rate: 5 µg/cm2/min
**minimum detectable permeation rate: 7 µg/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
Latex gloves
Personal Protective
Equipment
Keep away from sunlight
Gloves with non-latex
inner layer
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. 2.2
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