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2021

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510(k) Premarket Notification

The surgical face mask is listed in the Premarket Notification(510k) by US FDA. A 510(k) is a premarket submission made to FDA to demonstrate that the product to be marketed is as safe and effective.


The surgical face mask, an essential product in the healthcare field, is proudly listed in the Premarket Notification (510k) by the US FDA. A 510(k) submission is a crucial premarket step taken to demonstrate that the product to be marketed is not only safe but also highly effective. This recognition is a testament to the quality and reliability of our surgical face masks.

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