Device Classification Name |
latex patient examination glove
|
510(k) Number |
K061551 |
Device Name |
POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS) |
Applicant |
MEDIPURE CORPORATION (M) SDN. BHD. |
LOT 12 MEDAN TASEK |
TASEK INDUSTRAIL ESTATE |
IPOH, PERAK,
MY
31400
|
|
Applicant Contact |
TERENCE LIM SIN KOOI |
Correspondent |
MEDIPURE CORPORATION (M) SDN. BHD. |
LOT 12 MEDAN TASEK |
TASEK INDUSTRAIL ESTATE |
IPOH, PERAK,
MY
31400
|
|
Correspondent Contact |
TERENCE LIM SIN KOOI |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 06/05/2006 |
Decision Date | 08/24/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|