Thailand FDA 510(k) Overview
Leading Thailand FDA 510(k) manufacturers include Sri Trang Gloves (Thailand) Public Company Limited, Suretex Limited, Thai Nippon Rubber Industry Public Company Limited. and 25 others.
Thai medical device manufacturers have submitted 48 FDA 510(k) notifications since 2020, achieving a 100% clearance rate across 27 manufacturers. Thailand's medtech sector is particularly active in medical gloves, disposable devices and examination equipment, reflecting the country's established position as a major global supplier of rubber-based medical products.
Active in FDA 510(k) submissions since 2020. Many Thailand manufacturers work with FDA regulatory consultants to support U.S. market entry.