Device |
powder-free polychloroprene patient examination glove |
Regulation Description |
Non-powdered patient examination glove. |
Definition |
A powder free polychloroprene patient examination glove is a disposable device made of polychloroprene rubber tthat 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 powder free polychloroprene patient examination glove is a disposable device made of polychloroprene rubber tthat 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 powder free polychloroprene patient examination glove is a disposable device made of polychloroprene rubber tthat 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 | OPC |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control Devices
(DHT4C)
|
Submission Type |
510(k)
|
Regulation Number |
880.6250
|
Device Class |
1
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|