Device Classification Name |
Medical Glove, Specialty
|
510(k) Number |
K121926 |
Device Name |
BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM |
Applicant |
NORTHSTAR HEALTHCARE HOLDINGS |
HAMILTON HOUSE, 10 QUEEN ST |
HAMILTON, BERMUDA,
IE
HM11
|
|
Applicant Contact |
WESLEY TOAVS |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 07/02/2012 |
Decision Date | 09/20/2012 |
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
|
|
|