Certifications

Every CS Med Gloves product line is developed to meet the highest international standards. Below are the certifications relevant to our product portfolio.

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.

Applies to: 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.

Applies to: 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.

Applies to: nitrile
AST

ASTM D5250

United States / International

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

Applies to: vinyl
CE

CE Mark

European Union

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

Applies to: 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.

Applies to: 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.

Applies to: 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%.

Applies to: nitrile vinyl

Request Documentation

Need compliance documentation for a specific product? Contact us and we will provide the relevant certificates promptly.

info@csmedgloves.com

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