Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K100369 |
Device Name |
POWDER-FREE NITRILE GLOVES, BLACK |
Applicant |
HL RUBBER INDUSTRIES SDN BHD |
LOT 10, KAWASAN |
PERINDUSTRIAN DIOH |
KUALA PILAH, NEGERI SEMBILAN,
MY
72000
|
|
Applicant Contact |
LAU SIONG HUT |
Correspondent |
HL RUBBER INDUSTRIES SDN BHD |
LOT 10, KAWASAN |
PERINDUSTRIAN DIOH |
KUALA PILAH, NEGERI SEMBILAN,
MY
72000
|
|
Correspondent Contact |
LAU SIONG HUT |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 02/12/2010 |
Decision Date | 05/20/2010 |
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
|
|
|