GUANTES NITRILO PROFESIONAL - PROFESSIONAL NITRILE GLOVES

CONFORMITY & STANDARDS

PRODUCT 

NITRILE EXAMINATION GLOVES (POWDER FREE)

 

CONFORMITY

(MDD, Annex IX) : Class I, Rule 5  93/42/EEC (as amended by Directive 2007/74/EC)

(First Schedule, Appendix 1): Class A, Rule 5 - Medical Device Regulation 2012 under the Medical Device Act 2012  

 

STANDARDS

EN ISO 13485

  • Medical Devices
  • Quality Management Systems
  • Requirements For Regulatory Purposes

 

ISO 14971

  • Medical Devices - Application of risk management to medical devices

 

ISO 10993-10

  • Biological evaluation of medical devices
  • Part 10 : Tests for irritation and delayed-type hypersensitivity

 

ISO 15223-1

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General Requirements

 

EN 980

Symbols for use in labelling of medical devices

 

EN 455-1

Requirements and Testing for Freedom from Holes

 

EN 455-2 

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 shelf life determination

 

EN 374-1

Protective glove against chemicals and micro-organisms - Part 1: Terminology and Performance requirement

 

EN 374-2

Protective glove against chemicals and micro-organisms - Part 2: Determination of resistance to Penetration

 

ASTM D3578 

Standard Specification for Rubber Examination Gloves

 

ATSM D5151

Standard Test Method for Detection of Holes in Medical Gloves

 

ASTM D5712 

Standard Test Method for Detection of Protein in Natural Rubber and its products using the Lowry Method

 

ASTM D6319 

Standard Specification for Nitrile Examination Gloves For Medical Application

 

ASTM D412

Standard Test Method for Vulcanised Rubber and Thermoplastic elastomers - Tension

 

Commission Regulation (EC) No. 1935/2004

Material and articles intended to come into contact with food

 

USA APPROVED

FDA 510(K) 

 

IN-HOUSE STANDARDS

Product free from :

  • Plasticizers
  • Phthalates Esters
  • Silicone oil
  • Amide

 

QUALITY SYSTEM CERTIFICATION

ISO 13485:2016

by SGS United Kingdom Limited 

 

NOTE:

*All supporting documentation for the above is retained by the manufacturer at their premises. 

*Declaration of Conformity with full list of certificates, standards and norms available for purchasing customers.