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 Wi
| Device Type ID | 2842 |
| Device Name | Pediatric/child Facemask |
| 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 B |
| Technical Method | Anthrophometric Data Requirement |
| Target Area | Respiratory Tract |
| Regulation Description | Surgical Apparel. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General Hospital |
| 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) |
| CFR Regulation Number | 878.4040 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OXZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2842 |
| Device | Pediatric/child Facemask |
| Product Code | OXZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Apparel. |
| CFR Regulation Number | 878.4040 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PRESTIGE AMERITECH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |