MERUFA® Nitrile medical examination gloves Nitrile gloves are made of synthetic rubber. Recommended for medical personnel, gastronomic, hairdressing and industrial sectors.
MERUFA® Nitrile medical examination gloves advantages: High resistance to chemicals Flexibility and precision in use, non-allergenic, latex free, suitable for latex sensitive people. Protection against viruses and bacteria.
Explore our medical nitrile gloves
Nitrile gloves MERUFA in blue are made of nitrile rubber (NBR). Personal Protective Equipment (PPE category III). Conformity to harmonized European standards has been demonstrated: EN 420, EN ISO 374-1, EN ISO 374-2, EN ISO 3744, EN ISO 374-5, EN 16523-1:2015+A1:2018.
Name of device / Brand : MERUFA® – nitrile examination gloves
Packing: 100 pcs/unit
10 packs/collecting carton
Color : blue
Type / registration : non-sterile, single use, powder free examination & protective gloves 100 pcs, sizes Small, Medium, Large, X-Large
Classification : Medical Device Class I, according to MD Regulation (EU)2017/745 Personal Protective Equipment Category III, according to PPE Regulation (EU) 2016/425
Medical Devices (EU)2017/745
Applied standards: EN 455-1:2000, EN 455-2:2015, EN 455-3:2015, EN 455-4:2009
CE marked product described above conforms to the requirements of the regulation for personal protective equipment PPE (EU) 2016/425
Personal Protective Equipment Category III, according to PPE Regulation (EU) 2016/425. Applied standards: EN ISO 374-1:2017-01, EN ISO 374-2:2020-03, EN 374-4:2020-03, EN 374-5:2017-02, EN ISO 21420:2020-09
Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food, and with Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (as amended)
Intended Use : Donning to prevent the like hood of food contamination during the preparation or handling and applies to every food handler
Gloves are suitable to be used with all types of food.
Quality Management System EN IS013485:2016
Nitrile gloves MERUFA
The quality of our products has been approved by a leading European notified body for various European directives, including the Personal Protective Equipment (PPE) Regulation, the Medical Devices Directive (MDD) and the EU Regulation 10-2011 on plastics intended to come into contact with food.
Independent testing and research organizations such as SATRA in the UK, DEKRA in Germany, TÜRCERT Technical Control and Certification INC., Central Institute for Labour Protection in Poland and QUACERT in Vietnam carry out a range of tests including, but not limited to, tests against restricted substances under the European REACH regulation.
Exam gloves standards
Medical gloves used in hospitals should have a product class designation and CE certification and assessment of conformity according to European standards. Pictograms referring to gloves as PPE are placed on the glove box. These are the standards EN ISO 374-1 to EN ISO 374-5.
Standards for exam gloves as personal protective equipment in accordance with Regulation (EU) No 2016/425:
EN ISO 21420 (replaces EN 420) general requirements, relevant glove testing and marking procedures, and information provided by the manufacturer. The standard does not address protective properties and should be used in conjunction with other standards.
Standards related to chemical and biological resistance: EN ISO 374-1 Protective gloves against hazardous chemicals and microorganisms. Part 1: Terminology and performance requirements for chemical risks
EN ISO 374-2 Protective gloves against hazardous chemicals and microorganisms. Part 2: Determination of resistance to penetration
EN 16523-1 Replaces EN 374-3 Determination of resistance of materials to permeation by chemicals. Part 1: Permeation of potentially hazardous liquid chemicals under continuous contact conditions
EN ISO 374-4 Protective gloves against hazardous chemicals and micro-organisms. Part 4: Determination of resistance to degradation by chemicals
EN ISO 374-5 Protective exam gloves against hazardous chemicals and micro-organisms. Part 5: Terminology and requirements for risk of transmission of microorganisms
Standards for medical gloves as a medical device complying with Regulation (EU) No 2017/745:
EN 455-1 Medical gloves for single use. Part 1: Requirements and testing for absence of holes
EN 455-2 Medical gloves for single use. Part 2: Requirements and testing for physical properties
EN 455-3 Medical gloves for single use. Part 3: Requirements and testing for biological evaluation
EN 455-4 Medical gloves for single use. Part 4: Requirements and testing for shelf life determination