Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K100694 |
Device Name |
COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN |
Applicant |
TEKMEDIC (M) SDN BHD |
PLOT 4, TANJUNG KLING |
INDUSTRIAL AREA, TANJUNG BRUAS |
JETTY, TANJUNG KLING, MELAKA,
MY
76400
|
|
Applicant Contact |
PATRICK LEONG |
Correspondent |
TEKMEDIC (M) SDN BHD |
PLOT 4, TANJUNG KLING |
INDUSTRIAL AREA, TANJUNG BRUAS |
JETTY, TANJUNG KLING, MELAKA,
MY
76400
|
|
Correspondent Contact |
PATRICK LEONG |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 03/11/2010 |
Decision Date | 06/25/2010 |
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
|
Recalls |
CDRH Recalls
|
|
|