| 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 Code | OXZ |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices
(DHT4B)
|
| 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
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
