Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K003934 |
Device Name |
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) |
Applicant |
SELTOM PACIFIC SDN. BHD. |
BERANANG |
MUKIM BERANANG |
SELANGOR DARUL EHSAN,
MY
43700
|
|
Applicant Contact |
S. SEAGARAN |
Correspondent |
SELTOM PACIFIC SDN. BHD. |
BERANANG |
MUKIM BERANANG |
SELANGOR DARUL EHSAN,
MY
43700
|
|
Correspondent Contact |
S. SEAGARAN |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 12/20/2000 |
Decision Date | 01/26/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|