Certificazioni

Ogni linea di prodotti CS Med Gloves è sviluppata per soddisfare i più alti standard internazionali. Di seguito le certificazioni pertinenti al nostro portafoglio prodotti.

FDA

FDA 510(k) Clearance

United States

Cleared 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.

Si applica a: nitrile vinyl
ISO

ISO 9001:2015

International

International standard for quality management systems. Demonstrates consistent ability to provide products that meet customer and regulatory requirements.

Si applica a: nitrile vinyl cpe
AST

ASTM D6319

United States / International

Standard specification for nitrile examination gloves for medical application. Sets requirements for dimensions, tensile strength, and barrier performance.

Si applica a: nitrile
AST

ASTM D5250

United States / International

Standard specification for poly(vinyl chloride) gloves for medical application. Defines performance requirements for vinyl examination gloves.

Si applica a: vinyl
CE

CE Mark

European Union

European Conformity marking indicating the product meets EU health, safety, and environmental protection requirements for the European market.

Si applica a: nitrile vinyl
EN

EN 455

European Union

European standard for medical gloves for single use. Covers dimensions, freedom from holes, physical properties, and biological evaluation.

Si applica a: nitrile vinyl
EN

EN 374

European Union

European standard for protective gloves against dangerous chemicals and micro-organisms. Specifies requirements for penetration, permeation, and degradation resistance.

Si applica a: nitrile
AQL

AQL 1.5

International

Acceptable 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%.

Si applica a: nitrile vinyl

Richiedi Documentazione

Avete bisogno di documentazione di conformità per un prodotto specifico? Contattateci e forniremo i certificati pertinenti tempestivamente.

info@csmedgloves.com

Pronti a effettuare un ordine all'ingrosso?

Contattate il nostro team per discutere prezzi, logistica e opzioni di marchio privato.

Mettetevi in contatto