| Device Type ID | 2548 |
| Device Name | Patient Examination Glove |
| Regulation Description | Non-powdered Patient Examination Glove. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.6250 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FMC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 2548 |
| Device | Patient Examination Glove |
| Product Code | FMC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Non-powdered Patient Examination Glove. |
| CFR Regulation Number | 880.6250 [🔎] |
| Device Problems | |
|---|---|
Torn Material | 15 |
Material Integrity Problem | 5 |
Out-Of-Box Failure | 4 |
Crack | 3 |
Device Damaged Prior To Use | 3 |
Split | 2 |
Break | 2 |
Hole In Material | 2 |
Device Operates Differently Than Expected | 2 |
Cover | 1 |
Fitting Problem | 1 |
Defective Device | 1 |
Packaging Problem | 1 |
Nonstandard Device | 1 |
| Total Device Problems | 43 |