Pediatric/Child Facemask

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

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown