| Device |
powdered polychloroprene patient examination glove |
| Regulation Description |
Patient examination glove. |
| Definition |
A powdered polychloroprene patient examination glove is a disposable device made of polychloroprene rubber that bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. |
| Physical State |
A powdered polychloroprene patient examination glove is a disposable device made of polychloroprene rubber that bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. |
| Technical Method |
A powdered polychloroprene patient examination glove is a disposable device made of polychloroprene rubber that bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. |
| Target Area |
glove |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | OPB |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.6250
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Guidance Document
- Draft Guidance for Industry and FDA Staff - Recommended Warning for Surgeon's Gloves and Patient Examination Gloves that Use Powder
|
|
| Third Party Review |
Not Third Party Eligible |
