OXZClass II

Pediatric/Child Facemask

21 CFR 878.4040 / General, Plastic Surgery

OXZ is the FDA product code for Pediatric/Child Facemask, a class II device type, regulated under 21 CFR 878.4040. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 9 510(k) clearances under this code, the most recent dated 2023-12-21, and no recalls.

Classification record

Product code: OXZ
Device name: Pediatric/Child Facemask
FDA 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.
Regulation: 21 CFR 878.4040
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 9
Ingested recalls: 0

Clearances, product code OXZ

By decision year

9 clearances under product code OXZ with a decision year between 2011 and 2023, 2021 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code OXZ by decision year
Year	Clearances
2011	1
2012	1
2016	1
2019	1
2021	2
2022	2
2023	1

Applicants with the most clearances

Product code OXZ

Applicants holding the most 510(k) clearances under product code OXZ
Applicant	Clearances
Kimberly-Clark Corporation	2
AMD Medicom Inc.	1
Dukal LLC	1
Pac-Dent Inc.	1
Prestige Ameritech	1
Primed Medical Products Inc.	1
Shandong Shengquan New Material Co., Ltd.	1
Xinxiang Kangbeier Medical Technology Co., Ltd.	1

Companies listing this code with FDA

Companies whose registered establishments list this code