Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K150103 |
Device Name |
Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs |
Applicant |
HARTALEGA SDN BHD |
C-G-9 JALAN DATARAN |
SD1 DATARAN SD PJU 9 |
BANDAR SRI DAMANSARA,
MY
52200
|
|
Applicant Contact |
Kuan Kam Hon |
Correspondent |
HARTALEGA SDB. BHD. |
NO. 7 KAWASAN PERUSAHAAN |
SURIA |
BESTARI JAYA, SELANGOR,
MY
45600
|
|
Correspondent Contact |
Nurul Aisyah Kong Bt Abdullah |
Regulation Number | 880.6250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/20/2015 |
Decision Date | 04/23/2015 |
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
|