Global Medical Device Certifications & Compliance
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50
+
Global Certifications
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30
+ years
Manufacturing 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.
MDR
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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 B
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![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 D
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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 455
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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 388
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![EN 388]()
EN 374 specifies requirements for protection against chemicals and microorganisms, ensuring suitability for high-risk applications.
EN 374
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![EN 16523]()
EN 21420 specifies general requirements for protective gloves, including safety, comfort, and ergonomic performance.
EN 21420
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![EN 21420]()
EN 16523 assesses resistance to chemical permeation, ensuring protective gloves provide safety in hazardous environments.
EN 16523
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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)
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US Standards
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![ASTM D5250]()
ASTM D6319 defines performance requirements for nitrile medical gloves, ensuring durability, safety, and consistent quality.
ASTM D6319
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![ASTM D6319]()
ASTM D6978 evaluates resistance to chemotherapy drug permeation, ensuring enhanced protection in medical settings.
ASTM D6978
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![ASTM D6978]()
ASTM D5250 defines quality and performance requirements for vinyl gloves, ensuring consistent and reliable use.
ASTM D5250
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Quality Management Certifications
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![BRCS]()
BRC sets global standards for product safety, quality management, and operational control in manufacturing.
BRC Certified
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![ISO 9001]()
ISO 9001 defines requirements for a quality management system, ensuring consistent product quality and continuous improvement.
ISO 9001
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![ISO 13485]()
ISO 13485 specifies quality management requirements for medical devices, ensuring regulatory compliance and product safety.
ISO 13485
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![MDSAP Certified]()
MDSAP allows a single audit to meet regulatory requirements across multiple medical device markets, improving global compliance efficiency.
MDSAP Certified
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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.
BSCI
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![ISO 14001]()
ISO 14001 establishes a framework for environmental management, supporting sustainable and responsible operations.
ISO 14001
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![ISO 45001]()
ISO 45001 defines requirements for occupational health and safety management, ensuring safer workplaces and risk control.
ISO 45001
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![SEDEX]()
Sedex is a supply chain platform, and SMETA is its audit methodology, supporting transparency and ethical supply chain management.
SEDEX Member
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![WRAP]()
WRAP certification verifies compliance with international standards for ethical, lawful, and safe manufacturing practices.
WRAP
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