Device Classification Name |
latex patient examination glove
|
510(k) Number |
K162175 |
Device Name |
Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less |
Applicant |
Viet Glove Corporation |
Cau Sat Hamlet, Lai Hung Commune |
Ben Cat District |
Bau Bang Province,
VN
|
|
Applicant Contact |
PHAM NGOC THANH |
Correspondent |
Viet Glove Corporation |
Cau Sat Hamlet, Lai Hung Commune |
Ben Cat District |
Bau Bang Province,
VN
|
|
Correspondent Contact |
TERENCE LIM |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 08/03/2016 |
Decision Date | 11/21/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|