Certificeringen
Elke CS Med Gloves-productlijn is ontwikkeld om te voldoen aan de hoogste internationale normen. Hieronder staan de certificeringen die relevant zijn voor ons productportfolio.
FDA 510(k) Clearance
United StatesCleared by the U.S. Food and Drug Administration for use as a medical examination glove. This clearance verifies the product meets FDA performance standards for medical devices.
ISO 9001:2015
InternationalInternational standard for quality management systems. Demonstrates consistent ability to provide products that meet customer and regulatory requirements.
ASTM D6319
United States / InternationalStandard specification for nitrile examination gloves for medical application. Sets requirements for dimensions, tensile strength, and barrier performance.
ASTM D5250
United States / InternationalStandard specification for poly(vinyl chloride) gloves for medical application. Defines performance requirements for vinyl examination gloves.
CE Mark
European UnionEuropean Conformity marking indicating the product meets EU health, safety, and environmental protection requirements for the European market.
EN 455
European UnionEuropean standard for medical gloves for single use. Covers dimensions, freedom from holes, physical properties, and biological evaluation.
EN 374
European UnionEuropean standard for protective gloves against dangerous chemicals and micro-organisms. Specifies requirements for penetration, permeation, and degradation resistance.
AQL 1.5
InternationalAcceptable Quality Level 1.5 — the international standard for pinhole testing of medical examination gloves. Indicates stringent quality control with a maximum defect rate of 1.5%.
Documentatie aanvragen
Heeft u nalevingsdocumentatie nodig voor een specifiek product? Neem contact met ons op en wij verstrekken de relevante certificaten onmiddellijk.
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