Global Medical Device Certifications & Compliance
- 50+Global Certifications
- 30+ yearsManufacturing Experience
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EU 2017/745 MDR
EU MDR 2017/745 certification confirms compliance with European medical device safety, quality, and regulatory standards.MDRMore
EU 2016/425 PPE
- 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 ensures audited production processes and ongoing quality control, supporting consistent conformity of PPE products in mass production.PPE Module DMore
EU Medical Standards
EN 455 defines safety and performance requirements for medical gloves in Europe, ensuring suitability for healthcare use.EN 455More
EU PPE Standards
EN 388 evaluates resistance to mechanical risks such as abrasion, cuts, and tears, ensuring reliable protection in industrial environments.EN 388More
EN 374 specifies requirements for protection against chemicals and microorganisms, ensuring suitability for high-risk applications.EN 374More- EN ISO 21420 specifies general requirements for protective gloves, including safety, comfort, and ergonomic performance.EN ISO 21420More
- EN 16523 assesses resistance to chemical permeation, ensuring protective gloves provide safety in hazardous environments.EN 16523More
US FDA 510(k)
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
ASTM D6319 defines performance requirements for nitrile medical gloves, ensuring durability, safety, and consistent quality.ASTM D6319More- ASTM D6978 evaluates resistance to chemotherapy drug permeation, ensuring enhanced protection in medical settings.ASTM D6978More
- ASTM D5250 defines quality and performance requirements for vinyl gloves, ensuring consistent and reliable use.ASTM D5250More
Quality Management Certifications
BRC sets global standards for product safety, quality management, and operational control in manufacturing.BRC CertifiedMore
ISO 9001 defines requirements for a quality management system, ensuring consistent product quality and continuous improvement.ISO 9001More
ISO 13485 specifies quality management requirements for medical devices, ensuring regulatory compliance and product safety.ISO 13485More
MDSAP allows a single audit to meet regulatory requirements across multiple medical device markets, improving global compliance efficiency.MDSAP CertifiedMore
Sustainability & Social Compliance
BSCI provides a framework for improving social compliance in supply chains, promoting ethical sourcing and responsible production.BSCIMore
ISO 14001 establishes a framework for environmental management, supporting sustainable and responsible operations.ISO 14001More
ISO 45001 defines requirements for occupational health and safety management, ensuring safer workplaces and risk control.ISO 45001More
Sedex is a supply chain platform, and SMETA is its audit methodology, supporting transparency and ethical supply chain management.Sedex MemberMore
WRAP certification verifies compliance with international standards for ethical, lawful, and safe manufacturing practices.WRAPMore
MDR
EU MDR 2017/745 certification demonstrates that the product meets strict European requirements for medical device safety, quality control, risk management, and market compliance.
PPE Module B
PPE Module B (EU Type Examination) is a conformity assessment procedure under EU Regulation (EU) 2016/425 for personal protective equipment. It involves an independent notified body reviewing and certifying the product design.
PPE Module D
PPE Module D is a production quality assurance procedure under EU PPE regulations. It ensures that a notified body audits and monitors manufacturing processes, guaranteeing that mass-produced PPE consistently conforms to the approved design.
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PreviewEN 455
EN 455 is a European standard for single-use medical gloves. It defines requirements for barrier integrity, physical properties, and biological safety, ensuring gloves are suitable and reliable for use in healthcare environments.
EN 388
EN 388 is a European standard assessing protective gloves against mechanical risks. It evaluates resistance to abrasion, cuts, tears, and punctures, helping users select appropriate gloves for industrial and physical hazard environments.
EN 374
EN 374 specifies requirements for protective gloves against chemicals and microorganisms. It includes testing for chemical resistance and protection against bacteria, fungi, and viruses, supporting safe use in high-risk environments.
EN ISO 21420
EN ISO 21420 specifies general requirements for protective gloves in Europe. It covers ergonomics, comfort, sizing, and material safety, ensuring gloves provide both effective protection and usability for a wide range of applications.
EN 16523
EN 16523 defines test methods for evaluating chemical permeation resistance in protective gloves. It measures breakthrough time under exposure, ensuring reliable protection for users handling hazardous substances.
US FDA 510(k)
FDA 510(k) clearance is a U.S. regulatory pathway for medical devices. It demonstrates substantial equivalence to a legally marketed device, allowing products to enter the U.S. market.
ASTM D6319
ASTM D6319 is a U.S. standard for nitrile examination gloves. It defines requirements for physical strength, barrier integrity, and dimensions, ensuring consistent quality and reliable protection in medical applications.
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PreviewASTM D6978
ASTM D6978 evaluates medical glove resistance to chemotherapy drug permeation. It ensures gloves provide adequate protection when handling hazardous drugs, making it essential for oncology and pharmaceutical applications.
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PreviewASTM D5250
ASTM D5250 is a U.S. standard for vinyl examination gloves. It specifies requirements for physical properties and barrier performance, ensuring consistent quality and suitability for medical and general-purpose use.
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PreviewBRC Certified
BRC sets global standards for product safety and quality management. It ensures manufacturers implement strict controls, risk management, and traceability systems to maintain consistent product integrity.
ISO 9001
ISO 9001 is an international standard for quality management systems. It focuses on process control, customer satisfaction, and continuous improvement, ensuring consistent product quality and operational efficiency.
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PreviewISO 13485
ISO 13485 specifies quality management requirements for medical devices. It emphasizes risk management and regulatory compliance, ensuring product safety and consistent performance throughout the product lifecycle.
MDSAP Certified
MDSAP allows a single audit to meet medical device regulatory requirements across multiple countries, including the U.S., Canada, Japan, Brazil, and Australia, improving efficiency and reducing compliance duplication.
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PreviewBSCI
BSCI is a supply chain compliance framework that promotes ethical working conditions. It focuses on labor rights, health and safety, and fair wages, helping companies improve social responsibility in global sourcing.
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PreviewISO 14001
ISO 14001 establishes a framework for environmental management systems. It helps organizations control environmental impact, improve sustainability, and ensure compliance with environmental regulations.
ISO 45001
ISO 45001 defines requirements for occupational health and safety management systems. It focuses on risk prevention, workplace safety, and continuous improvement to protect employee well-being.
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PreviewSedex Member
Sedex is a global supply chain platform, and SMETA is its audit methodology. It evaluates labor standards, health and safety, environmental impact, and business ethics to support transparency and responsible sourcing.
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PreviewWRAP
WRAP certification verifies compliance with international standards for ethical manufacturing. It covers labor practices, workplace safety, and environmental responsibility, demonstrating commitment to lawful and responsible production.
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