Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K162923 |
Device Name |
NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINA |
Applicant |
HARTALEGA NGC SDN. BHD. |
KAWASAN PERINDUSTRIAN TANJUNG |
SEPANG,
MY
43900
|
|
Applicant Contact |
KUAN MUN LEONG |
Correspondent |
HARTALEGA NGC SDN. BHD. |
C-G-9, JALAN DATARAN SD1 |
DATARAN SD PJU 9C |
BANDAR SRI DAMANSARA,
MY
52200
|
|
Correspondent Contact |
NURUL AISYAH KONG BT ABDULLAH |
Regulation Number | 880.6250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/18/2016 |
Decision Date | 02/06/2017 |
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
|