Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K120890 |
Device Name |
POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE |
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 | 03/23/2012 |
Decision Date | 08/17/2012 |
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
|
|
|