Device Classification Name |
Polymer Patient Examination Glove
|
510(k) Number |
K031591 |
Device Name |
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED |
Applicant |
PERUSAHAAN GETAH ASAS SDN BHD |
1301 DEFENSE HIGHWAY |
GAMBRILLS,
MD
21054 -1928
|
|
Applicant Contact |
JAMES F LOGAN |
Correspondent |
PERUSAHAAN GETAH ASAS SDN BHD |
1301 DEFENSE HIGHWAY |
GAMBRILLS,
MD
21054 -1928
|
|
Correspondent Contact |
JAMES F LOGAN |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 05/21/2003 |
Decision Date | 06/26/2003 |
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
|
|
|