Sterile, single-use, powder-free nitrile exam gloves (pairs) are intended to be used for medical purposes for cross-contamination protection of the patient and examiner.

Quality Assurance

We have established a strict quality assurance system for product design, R&D, production, sales and service.

Home Support Quality Assurance

Product Standards

EN374@2x

EN 374

INTCO is certified to EN 374, verifying protection against chemicals and microorganisms for professional gloves.

EN388@2x

EN 388

INTCO meets EN 388, certifying mechanical resistance for industrial and general protection gloves.

EN455@2x

EN 455

INTCO meets EN 455, the European standard for medical gloves ensuring safety and reliability.

EN455@2x

EN 21420

INTCO complies with EN 21420 for protective glove performance and safety.

EN455@2x

EN 16523

INTCO adheres to EN 16523 for chemical and microbiological protection in professional use.

ASTM D6319@2x

ASTM D6319

INTCO meets ASTM D6319 for disposable nitrile glove performance, ensuring safety and durability in medical use.

ASTM D6319@2x

ASTM D6978

INTCO complies with ASTM D6978, verifying resistance to chemotherapy drug permeation for medical protection.

ASTM D6319@2x

ASTM D5250

INTCO adheres to ASTM D5250 standard for vinyl glove quality and performance.

Regulatory Compliance

FDA 510K@2x

FDA 510K

INTCO’s tampons have FDA 510(k) clearance, confirming their safety and substantial equivalence to legally marketed U.S. medical devices.

CE@2x

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@2x

MDSAP

INTCO is MDSAP certified, enabling single audit recognition across five major medical device markets.

CE@2x

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.

CE@2x

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@2x

BRC

INTCO has BRC certification, meeting global standards for product safety and quality control.

ISO 9001@2x

ISO 9001

INTCO is ISO 9001 certified, maintaining a strict quality management system for consistent excellence.

ISO 13485@2x

ISO 13485

INTCO holds ISO 13485 certification for medical device quality management, ensuring safety and compliance.

Social Compliance Certifications

WRAP@2x

WRAP

INTCO is WRAP certified, committing to ethical, safe and responsible manufacturing.

BSCI@2x

BSCI

INTCO follows BSCI requirements, upholding social compliance and ethical supply chain management.

SEDEX@2x

SEDEX

INTCO is SEDEX certified, ensuring transparent and responsible ethical supply chain practices.

ISO 14001@2x

ISO 14001

INTCO is ISO 14001 certified, managing environmental responsibilities systematically for sustainable operations.

ISO 45001@2x

ISO 45001

INTCO complies with ISO 45001, ensuring a safe and healthy workplace for all employees.