Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K091652 |
Device Name |
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS |
Applicant |
HARTALEGA SDN BHD |
NO. 7, KAWASAN PERUSAHAAN |
SURIA |
BESTARI JAYA,
MY
45600
|
|
Applicant Contact |
NURUL AISYAH KONG BT ABDULLAH |
Correspondent |
HARTALEGA SDN BHD |
NO. 7, KAWASAN PERUSAHAAN |
SURIA |
BESTARI JAYA,
MY
45600
|
|
Correspondent Contact |
NURUL AISYAH KONG BT ABDULLAH |
Regulation Number | 880.6250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/09/2009 |
Decision Date | 09/04/2009 |
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
|