Device Classification Name |
Polymer Patient Examination Glove
|
510(k) Number |
K121528 |
Device Name |
POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR |
Applicant |
SHEN WEI (USA), INC. |
33278 CENTRAL AVE., |
SUITE 102 |
UNION CITY,
CA
94587
|
|
Applicant Contact |
ALBERT LI |
Correspondent |
SHEN WEI (USA), INC. |
33278 CENTRAL AVE., |
SUITE 102 |
UNION CITY,
CA
94587
|
|
Correspondent Contact |
ALBERT LI |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 05/23/2012 |
Decision Date | 09/11/2012 |
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
|
|
|