Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K001165 |
Device Name |
POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
Applicant |
MEDIPURE CORPORATION (M) SDN. BHD. |
NO: 14, JALAN TAIPING |
KUALA KANGSAR, PERAK,
MY
33000
|
|
Applicant Contact |
LEE SON HONG |
Correspondent |
MEDIPURE CORPORATION (M) SDN. BHD. |
NO: 14, JALAN TAIPING |
KUALA KANGSAR, PERAK,
MY
33000
|
|
Correspondent Contact |
LEE SON HONG |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 04/10/2000 |
Decision Date | 07/05/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|