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