Device Classification Name |
latex patient examination glove
|
510(k) Number |
K012558 |
Device Name |
POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS |
Applicant |
MATANG MFG. SDN. BHD. |
6324 MEETING HOUSE WAY |
ALEXANDRIA,
VA
22312 -1718
|
|
Applicant Contact |
KOK-KEE HON |
Correspondent |
MATANG MFG. SDN. BHD. |
6324 MEETING HOUSE WAY |
ALEXANDRIA,
VA
22312 -1718
|
|
Correspondent Contact |
KOK-KEE HON |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 08/08/2001 |
Decision Date | 09/17/2001 |
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
|