Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K153708 |
Device Name |
Halyard Black-Orange Powder-Free Nitrile Exam Glove |
Applicant |
Halyard Health |
5405 Windward Parkway |
Alpharetta,
GA
30004
|
|
Applicant Contact |
Christine L Macauley |
Correspondent |
Halyard Health |
5405 Windward Parkway |
Alpharetta,
GA
30004
|
|
Correspondent Contact |
Christine L Macauley |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 12/23/2015 |
Decision Date | 03/31/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|