Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K030560 |
Device Name |
POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE |
Applicant |
PT. SHAMROCK MANUFACTURING CORP. |
5445 DANIELS ST. |
CHINO,
CA
91710
|
|
Applicant Contact |
EMMY TJOENG |
Correspondent |
PT. SHAMROCK MANUFACTURING CORP. |
5445 DANIELS ST. |
CHINO,
CA
91710
|
|
Correspondent Contact |
EMMY TJOENG |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 02/21/2003 |
Decision Date | 03/21/2003 |
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
|