| Device |
antimicrobial medical glove |
| Regulation Description |
Patient examination glove. |
| Definition |
A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner and to serve the indicated use of the added antimicrobial agent which may vary with the added antimicrobial agent. |
| Physical State |
A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner and to serve the indicated use of the added antimicrobial agent which may vary with the added antimicrobial agent. |
| Technical Method |
A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner and to serve the indicated use of the added antimicrobial agent which may vary with the added antimicrobial agent. |
| Target Area |
Glove |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | OPI |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.6250
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
