In-House Safety & Certifications

We ensure top-quality through in-house testing and global certifications, guaranteeing product reliability and safety.

End-to-End Quality Control

We oversee every step of the production process, ensuring consistency and superior quality from raw material sourcing to the final product. Each stage is carefully checked to maintain our high standards.

Continuous Testing and Monitoring

With our in-house QA lab, we conduct ongoing testing for durability, chemical resistance, and overall safety. Every batch is rigorously tested to meet the highest industry standards.

Compliance with Global Standards

Our gloves comply with major international certifications such as ISO 13485, FDA 510(k), CE, and EN 374, guaranteeing they meet or exceed the required safety and performance benchmarks for healthcare, pharma, and industrial applications.

Performance and Safety Testing

We perform multiple tests, including biocompatibility (ISO 10993), chemical resistance (EN 374), and food-grade compliance (US-FDA 177), to ensure our gloves deliver optimal protection in real-world conditions.

Full Traceability and Documentation

Each product is fully traceable with batch coding, COA/COC, and QR-based systems, ensuring complete transparency and meeting regulatory requirements for audits and submissions.

Certified by India’s Drug Control Authority

Certified by the Central Drugs Standard Control Organization (CDSCO) for medical device compliance in India.

International Quality Management Standard

ISO 13485 ensures Sri Anusham adheres to the highest quality standards for medical devices, focusing on product safety and consistency.

Recognizing Excellence in Manufacturing

Awarded by MSME for achieving zero defects and demonstrating a commitment to continuous improvement in production processes.

FDA Approval for Medical Devices

FDA 510(k) approval ensures that our medical devices meet the U.S. Food and Drug Administration's regulatory standards for safety and effectiveness.

CE Marking for European Safety Compliance

CE marking certifies that Sri Anusham products meet European Union health, safety, and environmental protection standards.

Global Regulatory Adherence

We adhere to rigorous global industry standards and certifications, ensuring compliance with regulations in all countries.

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