Device Classification Name |
Medical Glove, Specialty
|
510(k) Number |
K083305 |
Device Name |
POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM |
Applicant |
WRP ASIA PACIFIC SDN. BHD. |
LOT 1, JALAN 3, |
KAWASAN PERUSAHAAN BANDAR BARU |
SALAK TINGGI, SEPANG SELANGOR,
MY
43900
|
|
Applicant Contact |
KIRK PENNER |
Correspondent |
WRP ASIA PACIFIC SDN. BHD. |
LOT 1, JALAN 3, |
KAWASAN PERUSAHAAN BANDAR BARU |
SALAK TINGGI, SEPANG SELANGOR,
MY
43900
|
|
Correspondent Contact |
KIRK PENNER |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 11/10/2008 |
Decision Date | 06/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|