DeviceClearance

Product code OXZ— General, Plastic Surgery

Child Face Mask

Classification name
Pediatric/Child Facemask
Device class
Class 2
Regulation
21 CFR 878.4040
Advisory panel
General, Plastic Surgery
Total cleared
9
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OXZ under 21 CFR 878.4040, via openFDA

Market context for product code OXZ

FDA has cleared 9 devices under product code OXZ between 2011 and 2023, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OXZ

Recent clearances under product code OXZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.