Pediatric/Child Facemask

What Is This Device?

A pediatric/child facemask is intended to be worn by the patient/child to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. The facemask is recommended for use in a healthcare setting with appropriate adult supervision.

How Is OXZ Classified?

Pediatric/Child Facemask is FDA product code OXZ, Class 2, 21 CFR 878.4040.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 2 clearances under this code; the FDA took a median of 521 days from receipt to decision on them.