Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K013554 |
Device Name |
POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) |
Applicant |
MAXTER GLOVE MANUFACTURING SDN BHD |
6TH MILES OFF JALAN MERU |
KLANG SELANGOR,
MY
41050
|
|
Applicant Contact |
STANLEY THAI |
Correspondent |
MAXTER GLOVE MANUFACTURING SDN BHD |
6TH MILES OFF JALAN MERU |
KLANG SELANGOR,
MY
41050
|
|
Correspondent Contact |
STANLEY THAI |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 10/25/2001 |
Decision Date | 01/17/2002 |
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
|