MERCATOR RD30019001-05 Examination and Protective Gloves Instructions

MERCATOR RD30019001-05 Examination and Protective Gloves

MODELS

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.

Descriptions

Short description of the product

• Examination and protective gloves, nitrile, powder-free, for single use, non-sterile

Full description of the product

• Reference number: RD30019001-05; RD30096001-05; RD30174001-05; RD30143001-05; RD30097001-05; RD30169001-05; RD30168001-05
• Raw material: nitrile
• Cuff: beaded
• Color: blue/white/violet
• Shape: ambidextrous, fitting to the right and left hand
• Size range: XS (5-6), S (6-7), M (7-8), L (8-9), XL (9-10)
• AQL: 1.0
• Quantity in packaging: 50/100/200 pcs. by weight
• Shelf life: 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

Classification & Compliance

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

Permeation performance levels

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

• Personal Protective Equipment

• Manufacturer

• Lot / batch number

• Catalogue number

• Expiry date

• Date of manufacture
  Indicates compliance with the requirements of Ukrainian market

• Keep dry

• Keep away from sunlight

• Temperature limitation 5-35°C

• Keep away from ozone

• Product quality is not ensured if the package is damaged

• Recyclable packaging

• Package can be treated as municipal waste

• Suitable for food contact (for details check the instruction for use)

• Nitrile gloves

• Powder-free gloves

• For single use only

• Non-sterile

• Designed to protect against to chemical risks acc. with EN ISO 374-1 (type B)

• Designed to protect against microorganism risks acc. with EN ISO 374-5

• Consult instructions for use

How to use

HOW TO PUT THE GLOVES ON?

• Take one glove from the box pulling by the cuff.
• Hold the glove by the cuff with the same hand you used to pull it from the box and put the other hand into the glove without touching the working surface.
• Stretch the glove on the right hand.
• Take another glove from the box with the hand wearing a glove.
• Put the glove on the hand and smooth it out.
• Done!

HOW TO TAKE THE GLOVES OFF?

• Hold the glove with a finger of the other hand at the cuff.
• Slide the glove down to mid-palm.
• Hold the other glove by its outer edge.
• When removing the gloves, turn them inside out.
• Hold both gloves without touching the contaminated walls.
• Removed gloves should be treated as healthcare waste.

February 2022, Rev. 2.1

References

• Mercator Medical – manufacturer of gloves and single-use medical materials
• Mercator Medical – manufacturer of gloves and single-use medical materials
• Mercator Medical – manufacturer of gloves and single-use medical materials

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