Thailand FDA 510(k) Overview
Leading Thailand FDA 510(k) manufacturers include Siam Sempermed Corp., Ltd., Innovative Gloves Co;, Ltd., Sri Trang Gloves (Thailand) Public Company Limited and 63 others.
Thai medical device manufacturers have submitted 148 FDA 510(k) notifications since 1989, achieving a 100% clearance rate across 66 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 1989. Many Thailand manufacturers work with FDA regulatory consultants to support U.S. market entry.
Search Thailand devices in FDA 510(k) database