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U.S. Department of Health and Human Services

Product Classification

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Device pediatric/child facemask
Regulation Description Surgical apparel.
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.
Physical State A pediatric/child facemask is constructed of nonwoven materials. A nosepiece is placed within the bindings for comfort and individualized fit. It is appropriately sized to the smaller faces of children across a diverse population. It is intended to be worn by the patient/child and is a single use, disposable device. It is intended to be worn by the pediatric patient to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials.
Technical Method Anthrophometric data requirement
Target Area Respiratory Tract
Regulation Medical Specialty General & Plastic Surgery
Review Panel General Hospital
Product CodeOXZ
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Infection Control Devices Branch (INCB)
Submission Type 510(k)
Regulation Number 878.4040
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible