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MedPurest surgical gown has passed FDA 510(k)

Aug. 25, 2021



Anhui Medpurest Medical Technology Co., Ltd. Our surgical gown had been approved the FDA 510kwhich means that our surgical gown items will be export to North American markets such as the United States and Canada. 

MedPurest surgical gown has passed FDA 510(k)

MedPurest surgical gown has passed FDA 510(k)

FDA 510k is the main ways for medical devices to be marketed in the United States. Due to the testing requirements are extremely stringent, The test reports are applicable to other markets usually. The biological report can be used for domestic product registration and EU CE registration, and the performance test report can be used in other international markets. This certification is the highest honor and guarantee pursued by international manufacturers.


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