| Device |
polymer patient examination glove |
| Regulation Description |
Patient examination glove. |
| Definition |
A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | LZA |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.6250
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Recognized Consensus Standards
|
|
Third Party Review
|
Accredited Persons
|
