Product code OXZ

Device name

Pediatric/Child Facemask

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4040

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset