INTCO certifications
Global Medical Device Certifications & Compliance
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50 +Global Certifications
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30 + yearsManufacturing Experience
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100 %Compliance Standards Met
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15000 +Global Customers Served
EU 2017/745 MDR
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![PPE Module D]()
EU MDR 2017/745 certification confirms compliance with European medical device safety, quality, and regulatory standards.MDRMore
EU 2016/425 PPE
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![PPE Module B]()
PPE Module B confirms EU-type examination of product design, verifying compliance with essential health and safety requirements before market entry.PPE Module BMore -
![PPE Module D]()
PPE Module D ensures audited production processes and ongoing quality control, supporting consistent conformity of PPE products in mass production.PPE Module DMore
EU Standards
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![EN 21420]()
EN 455 defines safety and performance requirements for medical gloves in Europe, ensuring suitability for healthcare use.EN 455More
EU Standards
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![EN 374]()
EN 388 evaluates resistance to mechanical risks such as abrasion, cuts, and tears, ensuring reliable protection in industrial environments.EN 388More -
![EN 388]()
EN 374 specifies requirements for protection against chemicals and microorganisms, ensuring suitability for high-risk applications.EN 374More -
![EN 16523]()
EN 21420 specifies general requirements for protective gloves, including safety, comfort, and ergonomic performance.EN 21420More -
![EN 21420]()
EN 16523 assesses resistance to chemical permeation, ensuring protective gloves provide safety in hazardous environments.EN 16523More
US FDA 510(k)
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![FDA 510K]()
FDA 510(k) clearance confirms a product is substantially equivalent to a legally marketed device, allowing entry into the U.S. market.US FDA 510(k)More
US Standards
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![ASTM D5250]()
ASTM D6319 defines performance requirements for nitrile medical gloves, ensuring durability, safety, and consistent quality.ASTM D6319More -
![ASTM D6319]()
ASTM D6978 evaluates resistance to chemotherapy drug permeation, ensuring enhanced protection in medical settings.ASTM D6978More -
![ASTM D6978]()
ASTM D5250 defines quality and performance requirements for vinyl gloves, ensuring consistent and reliable use.ASTM D5250More
Quality Management Certifications
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![BRCS]()
BRC sets global standards for product safety, quality management, and operational control in manufacturing.BRC CertifiedMore -
![ISO 9001]()
ISO 9001 defines requirements for a quality management system, ensuring consistent product quality and continuous improvement.ISO 9001More -
![ISO 13485]()
ISO 13485 specifies quality management requirements for medical devices, ensuring regulatory compliance and product safety.ISO 13485More -
![MDSAP Certified]()
MDSAP allows a single audit to meet regulatory requirements across multiple medical device markets, improving global compliance efficiency.MDSAP CertifiedMore
Sustainability & Social Compliance
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![BSCI]()
BSCI provides a framework for improving social compliance in supply chains, promoting ethical sourcing and responsible production.BSCIMore -
![ISO 14001]()
ISO 14001 establishes a framework for environmental management, supporting sustainable and responsible operations.ISO 14001More -
![ISO 45001]()
ISO 45001 defines requirements for occupational health and safety management, ensuring safer workplaces and risk control.ISO 45001More -
![SEDEX]()
Sedex is a supply chain platform, and SMETA is its audit methodology, supporting transparency and ethical supply chain management.SEDEX MemberMore -
![WRAP]()
WRAP certification verifies compliance with international standards for ethical, lawful, and safe manufacturing practices.WRAPMore
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