nitrile gloves medical eu directive pdf template

EU Regulatory Compliance Statement - Showa Gloves- nitrile gloves medical eu directive pdf template ,EU Regulatory Compliance Statement for gloves intended to come into contact with food Product: Glove type 720R (Polyester knitted glove with Nitrile rubber coating) Intended Food Contact Conditions: Gloves for handling all food types We confirm that the above mentioned product is in conformity with the applicable requirements of theStandard Guide for Assessment of Medical Gloves - ASTM1. Scope. 1.1 This guide is intended to assist in the identification and application of the most appropriate ASTM and associated standards for the assessment, development of specifications, and selection of medical gloves with the ultimate goal of maintaining the safety and health of healthcare workers who may come into contact with biological ...



Covid-19 Medical Devices: Regulatory Ecosystem Guide

Nitrile Gloves a) Nitrile b) Non-sterile c) Powder free: d) Outer gloves preferably reach mid-forearm (minimum 280 mm total length) e) Different sizes (6.5 &7) f) Quality compliant with the below standards, or equivalent: i. EU standard directive 93/42/EEC Class I, EN 455 ii. EU standard directive 89/686/EEC Category Ill, EN 374 iii.

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Medical Device Directive (MDD)

Slide 1 of 37 Robert Packard, Consultant rob13485cert Medical Device Directive (MDD) 93/42/EEC as modified by 2007/47/EC

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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.

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Testing and Certification for PPE Gloves & the EU …

Gloves & the EU Regulations . Protective Gloves for Handheld Chainsaws – EN 381 . Protective Gloves for Fire Fighters –EN 659 . Protective Gloves for Ionizing Radiation – EN 421 . Protective Gloves for Professional Motorcycle riders – BS EN 13594 . Protective Gloves for Sport – Various standards dependent upon the sport

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MICROFLEX® 93-853

Medical Exam Gloves Description Designed for workers in high risk environments, Microflex® 93-853 is a durable nitrile glove with a low, 0.65 AQL and an extended cuff - for enhanced barrier integrity and expanded protection over the wrist and forearm.

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European Standard EN455 | JustGloves - Nitrile Gloves

This European Standard covers the minimum properties that address certain essential requirements detailed in the Medical Device Directive 93/42/EEC. EN455-1 Requirements and testing for freedom from holes. Gloves must pass this test in order to prove …

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Glove Information – The Glove Store - Nitrile

Glove Information (1) Main Types Of Examination / Disposable Glove (a) Latex – manufactured from natural rubber latex (NRL) which is a milky fluid obtained from the Hevea Brasiliensis tree found mainly in South East Asia. Latex gloves provide the best barrier protection in areas of potential risk associated with blood-borne pathogens and other biohazards.

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CRITERION® GLOVES PORTFOLIO

Powder-Free Nitrile Examination Gloves RELY ON US FOR QUALITY, SELECTION, PERFORMANCE, AND VALUE! To Order: 1.800.772.4346 8am–9pm (ET) • Fax: 1.800.329.9109 24 Hrs.

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Medical Device Directive (MDD)

Slide 1 of 37 Robert Packard, Consultant rob13485cert Medical Device Directive (MDD) 93/42/EEC as modified by 2007/47/EC

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Testing and Certification for PPE Gloves & the EU …

Gloves & the EU Regulations . Protective Gloves for Handheld Chainsaws – EN 381 . Protective Gloves for Fire Fighters –EN 659 . Protective Gloves for Ionizing Radiation – EN 421 . Protective Gloves for Professional Motorcycle riders – BS EN 13594 . Protective Gloves for Sport – Various standards dependent upon the sport

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SAFETY DATA SHEET - Surgilube

Oct 06, 2015·EU LABELING/CLASSIFICATION: According to Article 1 of European Union Council Directive 92/32/EEC, medical products in the finished state for human use (as defined by European Union Council Directives 67/548/EEC and 87/21/EEC) are not subject to the regulations and administrative provisions of European Union Council Directive 92/32/EEC.

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MATERIAL AND SAFETY DATA SHEET - Vital Medical Supplies

Powder free nitrile examination glove is classified as Class I medical device as per Rule 1, Annex IX of Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EC. 1.2 Brief Description The powder free nitrile examination glove is made from 100% nitrile synthetic rubber (NBR Protein Free), ambidextrous and non-sterile. It is

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The Interpretation of the Relative Cytotoxic Testing for ...

Medical EU Directive 93/42/EEC MDD EU Directive 93/42/EEC MDD EU Directive 89/686/EEC Article 11b Quality for PPE ... Nitrile BioClean P-Zero TM Polychloroprene Thick Latex**** Palm thickness (Typical) 0.14 0.12 0.17 0.41 ... ** ASTM D 6978-05. Definition: Standard practice for assessment of resistance of medical gloves to permeation by ...

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Testing and Certification for PPE Gloves & the EU …

Gloves & the EU Regulations . Protective Gloves for Handheld Chainsaws – EN 381 . Protective Gloves for Fire Fighters –EN 659 . Protective Gloves for Ionizing Radiation – EN 421 . Protective Gloves for Professional Motorcycle riders – BS EN 13594 . Protective Gloves for Sport – Various standards dependent upon the sport

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Nitrile Examination Gloves

Nitrile Examination Gloves PNitrile PPowder Free PWhite PTextured PXS-XL PAmbidextrous Made of a soft but tough stretchy Nitrile material, GN92 was developed to give increased sensitivity. Whilst designed for precision, GN92 is a very strong and a high quality flexible glove. (Formerly known as …

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Sempercare® nitrile skin² - Semperit Technische Produkte ...

Medical device class I as set out in MD Regulation (EU) 2017/745: Single-use protective glove – PPE category III (protection against chemical substances for limited time)* as set out in PPE Regulation (EU) 2016/425: Suitable for food contact (as per Regulation (EC) 1935/2004 on Food Contact Materials) ADDITIONAL INFORMATION

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EC-DECLARATION OF CONFORMITY Directive 93/42/EEC

Jan 15, 2020·It is hereby declared that the products listed below comply with the provisions of the EC Council Directive 93/42/EEC of June 14th 1993, concerning medical devices (MDD), Annex VII, as amended by EC Council Directive 2007/47/EC. Schottlander Super Soft Flexible Nitrile Examination Gloves, Schottlander Soft Touch Flexible Nitrile Examination Gloves,

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Medical Device Directive (MDD)

Slide 1 of 37 Robert Packard, Consultant rob13485cert Medical Device Directive (MDD) 93/42/EEC as modified by 2007/47/EC

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Personal protective equipment (PPE) - European Commission

EU legislation and PPE. Regulation (EU) 2016/425 of 9 March 2016 on personal protective equipment (the PPE regulation) covers the design, manufacture and marketing of personal protective equipment.It defines legal obligations to ensure that PPE on the EU internal market provides the highest level of protection against risks. The CE marking affixed to PPE provides evidence of compliance of the ...

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User Information Sheet

1) Medical Device Directive (MDD) a) This product is classified under Class I Medical Device per Rule 1 and Rule 5 of Annex IX, meets the provisions of the Council Directive 93/42/EEC, as amended by the Council Directive 2007/47/EC. b) This product complies with European Standards EN 455-1:2000, EN 455-2:2015, EN 455-3:2015, and EN 455-4:2009.

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UltraFLEX Blue Gloves NITRILE

Average powder mass per medium glove is 0.9mg, within standard requirement. Our gloves are fully compliant with the Essential Requirement of the EC Council Directive 93/42/EEC 14th June 1993 concerned medical devices, amended by Council Directive 2007/47/ EC. Part 3 - Chemical & Micro-organism Permeation Low chemical resistance for minimal risk.

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Technical documentation and EU declaration of conformity ...

Feb 19, 2021·The technical documentation provides information on the design, manufacture, and operation of a product and must contain all the details necessary to demonstrate the product conforms to the applicable requirements.. If you are the manufacturer, there are certain rules that must be followed when placing a product on the market; you must:. prepare the technical documentation before placing …

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Understanding glove certification

Medical Device Directive Gloves EN455 Are SELF Certified. Not submitted for EC type examination. Object is care of the patient For Patient protection Medical Device Directive Gloves EN455 Are SELF Certified. Not submitted for EC type examination. Object is care of the patient For Patient protection Medical Device gloves are self-certified

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The PPE Directive and the PPE Regulation

products like dish-washing gloves and oven gloves. Early preparation is key Timelines for the PPE Regulation (EU) 2016/425 20 days EC-Type Certificates to old PPE Directive can still be issued Seven Years: After 2023, EC-Type Certificates issued to old PPED will be invalid Two-year Transition Apr 2016 Apr 2018 Apr 2019 2023

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