nitrile gloves medical eu directive 3

Powder Free Nitrile Gloves Reflexx N80B - gr. 3,0 | Reflexx

The gloves considered Medical Devices provide protection from cross-contamination both for the patient and the user as they are considered an effective barrier to biological fluids and microorganisms. In April 2018 the New PPE Regulation EU 2016/425 has amended and replaced the previous PPE Directive …

1 LATEX GLOVES NITRILE GLOVES - Czechy | Czechy

3 NITRILE GLOVES Powder-free, examination and protective nitrile gloves, non-sterile, disposable, violet blue colour, 100 pieces/box. Quality Norms • In conformity with the essential requirements of Medical Devices Directive 93/42/EEC as ammended by Directive 2007/47/EC for Class 1 medical devices • Fulfill the requirements of Directive for ...

Use of gloves within COVID-19 - European Centre for ...

Medical gloves in EU/EEA countries should comply with requirements defined in the Council Directive 93/42/EEC [6] concerning medical devices and the Regulation (EU) 2016/425 [7] relating to personal protective equipment. The European Standard EN 455 on medical gloves for single use specifies requirements for the quality of medical gloves.

General Features and Specifications of Nitrile Gloves, by ...

Although nitrile gloves are known for its durability, extra care should be taken while handling with tarnish silver and high reactive metals because those substances can react with sulfur, an accelerant in nitrile gloves.[13] Powder-free medical gloves are used in medical cleanroom environments, where the need for cleanliness is often similar ...

What's the Difference Between Medical and Non-Medical Gloves?

Nov 05, 2020·Medical gloves belong to medical devices in THE European Union, and shall be marked with CE according to eu medical Devices Directive 93/42/EEC(MDD) or EU Medical Devices Regulation 2017/745/(MDR). The corresponding standard is EN 455-1/EN 455-2/ EN 455-3/ EN 455-4.

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Top Quality At Wholesale Prices. FDA Approved - 510K. Food and Medical Application. Latex Free Powder Free. Finger Textured for Better Grip. Skin Like Touch. 9.5" Length with Rolled Beaded Cuff. Dove Grey Color Disposable Nitrile Gloves. CALL 1-877-898-2057.

Powder Free Nitrile Gloves Reflexx 76 - gr. 3,5 (M) | Reflexx

The gloves considered Medical Devices provide protection from cross-contamination both for the patient and the user as they are considered an effective barrier to biological fluids and microorganisms. In April 2018 the New PPE Regulation EU 2016/425 has amended and replaced the previous PPE Directive 89/686/EEC. The new PPE regulation now ...

Latex and Nitrile Gloves Manufacturer - Obecare Pte Ltd

Provide an alternative solution for individuals who are allergic to natural rubber latex. Full textured or finger tip textured enhances wet and dry grip. SPECIFICATIONS. MATERIAL. 100% NITRILE (ACRYLONITRILE BUTADIENE) GLOVE SIZE. EXTRA SMALL, …

Sensi Gloves

-Conforms to ASTM D3578 and EN455 parts 1, 2, & 3.-In compliance with European Medical Device Directive 93/94/EEC (CE Class 1)-In compliance with Personal Equipment Directive 89/686/EEC (Complex Design Category and type tested to EN 420, EN 374-2, EN 374-3 and EN 388)

EU DECLARATION OF CONFORMITY - Disposable Gloves

4. Declaration purpose: POWDER FREE NITRILE GLOVE, NON-STERILE “AACHENFEEL BLACK” 5. The purpose of the declaration described in point 4 above is in accordance with the applicable Union harmonization legislation 425/2016 EU Regulation, for Personal Protective Equipment and 93/42 European Directive 93/42 for Medical Devices (Class I). 6.

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See the 6 products. Disposable nitrile glove Disposable nitrile glove. Website. To page. SPARBUTLER UG. SPARBUTLER UG. GERMANY - Duisburg. We are the main distributor (across Germany) of Comix Group Germany and can thereby provide any pandemic items, from gloves and masks to disposable clothing and the like.

EC Declaration of Product Conformity Stronghold Nitrile ...

Stronghold Nitrile (GM006*) Non-sterile, powder free, nitrile single use glove The manufacturer established in the Community declares that the new medical device and PPE described hereafter, Stronghold Nitrile, is in conformity with the provisions of Council Directive 93/42/EEC as amended, national standards EN455-1:2000, EN455-2:2015,

All-round protection is in your hands

EN374-3 Determination of resistance to Permeation by Chemicals Choosing the right glove EN374-1:2003 EN374-2:2003 AQL Virus Protection Material Protection level against Risks Product Code Description Sizing Glove Length Gloves/Case Biohazard3 Chemical4 Contaminants5 0.65 ISO 16604: 2004 Proc. B Nitrile 97610-97614 KIMTECH SCIENCE* PURPLE ...

KIMTECH™ Purple Nitrile Gloves – Powder Free & Latex Free ...

Products are usable as Medical Devices according to Directive 93/42 / EEC (reference standards EN 455 parts 1,2 and 3). Directive 93/42 / EEC on medical devices, provides the requirements for the production of gloves to be used in health (and therefore also dental), as well as the obligations of labeling and assessment of biological safety.