Device Classification Name |
Polymer Patient Examination Glove
|
510(k) Number |
K111328 |
Device Name |
POWDER FREE NITRILE EXAMINATION GLOVES |
Applicant |
GX CORPORATION SDN BHD |
LOT 6487, BATU 5 3/4, SEMENTA |
JALAN KAPAR |
KLANG, SELANGOR,
MY
42100
|
|
Applicant Contact |
GANESAN SUPIRAMUNIAM |
Correspondent |
GX CORPORATION SDN BHD |
LOT 6487, BATU 5 3/4, SEMENTA |
JALAN KAPAR |
KLANG, SELANGOR,
MY
42100
|
|
Correspondent Contact |
GANESAN SUPIRAMUNIAM |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 05/11/2011 |
Decision Date | 07/15/2011 |
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
|
|
|