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): 9

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.

Number	Decision date	Applicant	Device name	Summary
K221753	2023-12-21	Xinxiang Kangbeier Medical Technology	Kangbeier Child Surgical Mask	PDF

1 summaries are archived here for direct download.

Official FDA classification page: OXZ

Classification and pathway per current FDA publications. Data from openFDA (CC0).