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Disposable Coverall price:American Standard for medical protective clothing

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Disposable Coverall price:American Standard for medical protective clothing

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The U.S. Food and Drug Administration (FDA) divides medical device products into three levels for management according to the risk level. The first level refers to ordinary products, the second level refers to products that ensure their safety and effectiveness through special control, and the third level refers to products that are generally used to support human life, prevent damage to human health, and have potential unreasonable risks of disease treatment and disability.


Medical protective clothing in the United States can be divided into non-surgical protective clothing and surgical protective clothing. Non surgical protective clothing belongs to class I medical devices, which are exempted from pre-market registration and directly registered with institutions. The surgical protective clothing belongs to class II medical devices and needs to be registered before listing, that is, it needs to apply for FDA 510k.


Class II products shall be notified before listing, and the basic process is as follows

(1) Product test (performance test, chemical test)

(2) Prepare 510k files

(3) Submit to FDA for review

(4) FDA issued 510k approval

(5) Complete factory registration and machine listing

(6) Product export


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