Device Classification Name |
Polymer Patient Examination Glove
|
510(k) Number |
K122696 |
Device Name |
POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE) |
Applicant |
CARDINAL HEALTH, INC. |
1430 WAUKEGAN ROAD |
MCGAW PARK,
IL
60085
|
|
Applicant Contact |
TATYANA BOGDAN |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 09/04/2012 |
Decision Date | 01/31/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|