FDA introduces a new benchmark in the interest of surgical gowns
FDA guidelines define ANSI/AAMI PB70 compliance, barrier testing, and labeling requirements to classify gowns as Class II medical devices.
FDA guidelines define ANSI/AAMI PB70 compliance, barrier testing, and labeling requirements to classify gowns as Class II medical devices.
AORN guidelines ensure sterilization packaging provides strong microbial barriers, durability, and reliable sterility maintenance for medical instruments.
Surgical textile manufacturing requires strict EN 13795 compliance, validated processes, and complete documentation to ensure safety and consistent product quality.
Surgeine Healthcare delivers world-class surgical gowns and drapes to healthcare markets worldwide through strong global partnerships and trusted expertise.
India’s medical exports to Gulf Countries have surged, with Surgeine supplying globally trusted, high-quality surgical and PPE products.
Surgeine Healthcare holds the Star Export House Certification, recognizing its strong export performance and compliance with global quality standards.