Device Classification Name |
Vinyl Patient Examination Glove
|
510(k) Number |
K120746 |
Device Name |
DISPOSABLE POWDER FREE VINYL EXAM GLOVES |
Applicant |
CANOPUS MEDICAL SUPPLY CO., LTD. |
18709 GREEN BAT DR., |
ROWLAND HIGHS,
CA
91748
|
|
Applicant Contact |
GLORIA CHANG |
Correspondent |
CANOPUS MEDICAL SUPPLY CO., LTD. |
18709 GREEN BAT DR., |
ROWLAND HIGHS,
CA
91748
|
|
Correspondent Contact |
GLORIA CHANG |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 03/12/2012 |
Decision Date | 04/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|