| Device Type ID | 2814 |
| Device Name | Helmet, Surgical |
| Regulation Description | Surgical Apparel. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4040 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FXZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2814 |
| Device | Helmet, Surgical |
| Product Code | FXZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Apparel. |
| CFR Regulation Number | 878.4040 [🔎] |
| Device Problems | |
|---|---|
Overheating Of Device | 47 |
Smoking | 3 |
Material Split, Cut Or Torn | 1 |
Fire | 1 |
Temperature Problem | 1 |
Break | 1 |
Thermal Decomposition Of Device | 1 |
Leak / Splash | 1 |
Fitting Problem | 1 |
Electrical Shorting | 1 |
Air Leak | 1 |
Material Separation | 1 |
| Total Device Problems | 60 |