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U.S. Department of Health and Human Services

Product Classification

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Device pediatric/child facemask
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 Orthopedic
Product CodeOXZ
Premarket Review Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 878.4040
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible