Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K121844 |
Device Name |
POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES |
Applicant |
WORLDMED MANUFACTURING SDN. BHD. |
LOT 18873, JALAN PERUSAHAAN |
3, KAMUNTING INDUSTRIAL ESTATE |
KAMUNTING,
MY
34600
|
|
Applicant Contact |
CHANDRASEGARAN |
Correspondent |
WORLDMED MANUFACTURING SDN. BHD. |
LOT 18873, JALAN PERUSAHAAN |
3, KAMUNTING INDUSTRIAL ESTATE |
KAMUNTING,
MY
34600
|
|
Correspondent Contact |
CHANDRASEGARAN |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 06/25/2012 |
Decision Date | 09/06/2013 |
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
|
|
|