Device Classification Name |
Polymer Patient Examination Glove
|
510(k) Number |
K121549 |
Device Name |
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE |
Applicant |
SIAM SEMPERMED CORP. LTD. |
13900 49TH STREET NORTH |
CLEARWATER,
FL
33762
|
|
Applicant Contact |
WILLIAM E HARRIS |
Correspondent |
SIAM SEMPERMED CORP. LTD. |
13900 49TH STREET NORTH |
CLEARWATER,
FL
33762
|
|
Correspondent Contact |
WILLIAM E HARRIS |
Regulation Number | 880.6250 |
Classification Product Code |
|
Date Received | 05/25/2012 |
Decision Date | 12/27/2012 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|