| Device |
patient examination glove, specialty |
| Regulation Description |
Patient examination glove. |
| Definition |
A disposable latex examination glove is a device made of natural rubber latex or synthetic rubber that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminan.In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as astm d6978-05, standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | LZC |
|---|
| 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
|
