EN 374
INTCO is certified to EN 374, verifying protection against chemicals and microorganisms for professional gloves.
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Quality Assurance
We have established a strict quality assurance system for product design, R&D, production, sales and service.
Product Standards
EN 388
INTCO meets EN 388, certifying mechanical resistance for industrial and general protection gloves.
EN 455
INTCO meets EN 455, the European standard for medical gloves ensuring safety and reliability.
EN 21420
INTCO complies with EN 21420 for protective glove performance and safety.
EN 16523
INTCO adheres to EN 16523 for chemical and microbiological protection in professional use.
ASTM D6319
INTCO meets ASTM D6319 for disposable nitrile glove performance, ensuring safety and durability in medical use.
ASTM D6978
INTCO verifies glove performance through recognized standards, including ASTM methods for chemical resistance and medical protection.
ASTM D5250
INTCO adheres to ASTM D5250 standard for vinyl glove quality and performance.
Regulatory Compliance
FDA 510K
INTCO’s tampons have FDA 510(k) clearance, confirming their safety and substantial equivalence to legally marketed U.S. medical devices.
CE
CE marked indicates conformity with applicable EU health, safety, and environmental requirements, enabling products to be legally placed on the European market.
Quality & System Certifications
MDSAP
INTCO is MDSAP certified, enabling single audit recognition across five major medical device markets.
PPE Module B
INTCO holds PPE Module B certification, covering EU-type examination to confirm compliance with essential health and safety requirements for personal protective equipment.
PPE Module D
INTCO is certified under PPE Module D, ensuring consistent production quality control and conformity assurance for PPE products placed on the EU market.
BRC
INTCO has BRC certification, meeting global standards for product safety and quality control.
ISO 9001
INTCO is ISO 9001 certified, maintaining a strict quality management system for consistent excellence.
ISO 13485
INTCO holds ISO 13485 certification for medical device quality management, ensuring safety and compliance.
