OXZ

Pediatric/Child Facemask

Product code

OXZ

Device name

Pediatric/Child Facemask

Device class

Class 2

21 CFR

21 CFR 878.4040

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

9 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-12-21.

1 summaries are archived here for direct download.