FDA Product Code OXZ: Pediatric/child Facemask
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.
Leading manufacturers include Primed Medical Products, Inc., Xinxiang Kangbeier Medical Technology Co., Ltd. and Shandong Shengquan New Material Co., Ltd..
FDA 510(k) Cleared Pediatric/child Facemask Devices (Product Code OXZ)
About Product Code OXZ - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code OXZ since 2011, with 9 receiving FDA clearance (average review time: 353 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
OXZ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →