Nitrile Examination Gloves 510K+ASTM D6319

A 510(k) is a premarket application made to the FDA to show that the product being marketed is essentially equivalent—that is, equally safe and effective. Specifications for nitrile exam gloves ensure that they meet performance and safety requirements. Nitrile exam gloves are subjected to safety and performance tests under the ASTM D6319 standard specification for a range of applications, including medical examinations, therapeutic operations, and diagnostic procedures. The FDA regulates medical gloves as Class I reserved devices that need a 510(k) premarket notification. Typically, the FDA examines these devices to make sure performance standards are satisfied, including leak resistance, specific physical qualities, and biocompatibility. We ensure to provide the best gloves that match all the standard requirements. Support payment by L/C. $5.9FOB Min Moq One 40Ft Container $5.5FOB :Shanghai China Port 1M x 12 Month Max Moq 50M x 12Month For 1 Customer. I still have a production capacity of 10 billion a year We are looking for many agent that can promote our examination gloves. I am Seller Facalitator. LC Will Be Open Direct Factory at China