Certificate & Standard

Protective against dangerous chemicals and microorganisms

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Protective against dangerous chemicals and microorganisms

These gloves are 100% Nitrile (Acryonite), and are designed to provide an excellentbiological barrier and good resistance to bacteria, fungi, viruses and a variety of chemicals found in typical medical and industrial environments. It is recommended tocheck 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. 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 importantfactor to consider in selection of chemical resistant gloves.

*The range of chemicals tested and Type (A/B/C) under EN ISO 374-1:2016 may vary in for this product in different markets. For further information on chemical resistance,please contact us.

MDD classification & compliance: Council Directive 93/42/EEC

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MDD classification & compliance: Council Directive 93/42/EEC

Gloves are classified as class I Medical Device as per Annex VIII of the Medical Device Regulation 2017/745 and comply to standards: EN 455-1:2000, EN 455-2:2015, EN

455-3:2015, EN 455-4:2009, EN ISO 15223-1:2016, EN 1041:2008+A1:2013.

EN 455-1:2000 — Medical gloves for single use
Pt. 1: Requirements and testing for freedom from holes

EN 455-2:2015 — Medical gloves for single use
Pt. 2: Requirements and testing for physical properties

EN 455-3:2015 — Medical gloves for single use
Pt3: Requirements and testing for biological evaluation

EN 455-4:2009. Specification for nitrile examination gloves for medical application

PPE classification & compliance: PPE Directive (EU) 2016/425 (formerly 89/686/EEC)

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PPE classification & compliance: PPE Directive (EU) 2016/425 (formerly 89/686/EEC)

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 374-2:2014, EN 16523-1:2015, EN 374-4:2013, EN ISO 374-5:2016

EN 420:2003 — Protective gloves – general requirements and test methods

EN ISO 374-1:2016 — Protective gloves against dangerous chemicals and microorganisms
Pt. 1: Terminology and performance requirements for chemical risks

EN 374-2:2014 — Protective gloves against dangerous chemicals and microorganisms
Pt. 2: Determination of resistance to penetration

EN 16523-1:2015 — Determination of material resistance to permeation by chemicals
Pt. 1: Permeation by liquid chemical under conditions of continuouscontact

EN 374-4:2013 — Protective gloves against chemicals and micro-organisms
Pt. 4: Determination of resistance to degradation by chemicals

EN ISO 374-5:2016 — Protective gloves against dangerous chemicals and micro-organisms
Pt. 5: Terminology and performance requirements for micro-organisms risks

ASTM-D6319: Standard Specification for Nitrile Examination Gloves for Medical Application

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ASTM-D6319: Standard Specification for Nitrile Examination Gloves for Medical Application

Manufactured in FDA-registered facilities utilizing an FDA-registered 510(k) formulation. Meets US government 21-CFR specifications and the current specifications listed under the ASTM specification D6319, Standard for Nitrile Gloves for Medical Application; acceptable for use in food and pharmaceutical applications.
ASTM D 6319 Specification for nitrile examination gloves for medical application

ASTM-D3578: Standard Specification for Latex Examination Gloves for Medical Application

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ASTM-D3578: Standard Specification for Latex Examination Gloves for Medical Application

Manufactured in FDA-registered facilities utilizing an FDA-registered 510(k) formulation. Meets US government 21-CFR specifications and the current specifications listed under the ASTM specification D3578, Standard for Latex Gloves for Medical Application; acceptable for use in food and pharmaceutical applications.. ASTM D 3578 Specification for latex examination gloves for medical application