Device Classification Name |
Vinyl Patient Examination Glove
|
510(k) Number |
K113750 |
Device Name |
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR |
Applicant |
FULL SYNERGY MEDICAL PRODUCTS INC |
5748 EAGLEWOOD PLACE |
RANCHO CUCAMONGA,
CA
91739
|
|
Applicant Contact |
ELIZABETH DENG |
Correspondent |
FULL SYNERGY MEDICAL PRODUCTS INC |
5748 EAGLEWOOD PLACE |
RANCHO CUCAMONGA,
CA
91739
|
|
Correspondent Contact |
ELIZABETH DENG |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 12/21/2011 |
Decision Date | 03/05/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|