Device Classification Name |
Polymer Patient Examination Glove
|
510(k) Number |
K122727 |
Device Name |
BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE |
Applicant |
NORTHSTAR HEALTHCARE HOLDINGS |
70 SIR JOHN ROGERSONS QUAY |
DUBLIN 2,
IE
|
|
Applicant Contact |
MICHAEL RIORDAN |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 09/05/2012 |
Decision Date | 02/22/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|