Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K121591 |
Device Name |
FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY) |
Applicant |
TEKMEDIC (M) SDN BHD |
PLOT 4, TANJUNG KLING |
INDUSTRIAL AREA, TANJUNG BRUAS |
JETTY, TANJUNG KLING, MALACCA,
MY
76400
|
|
Applicant Contact |
PATRICK LEONG |
Correspondent |
TEKMEDIC (M) SDN BHD |
PLOT 4, TANJUNG KLING |
INDUSTRIAL AREA, TANJUNG BRUAS |
JETTY, TANJUNG KLING, MALACCA,
MY
76400
|
|
Correspondent Contact |
PATRICK LEONG |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 05/31/2012 |
Decision Date | 10/11/2012 |
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
|
|
|