# Pediatric/Child Facemask
> **Product code: OXZ** · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4040
## Classification
- **FDA Product Code:** OXZ
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 878.4040
- **Review panel:** HO
- **Medical specialty:** General, Plastic Surgery
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 9
- **Registered establishments:** 12
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OXZ)
---
*AI Analytics · CC0 1.0*