Device Classification Name |
vinyl patient examination glove
|
510(k) Number |
K122176 |
Device Name |
POWDERED VINYL EXAMINATION GLOVES |
Applicant |
SHU TONG XINGHUA CO., LTD. |
WEST OF XI HUAN ROAD |
ECONOMIC DEVELOPMENT DISTRICT |
XINGHUA,
CN
225700
|
|
Applicant Contact |
SU SONG SHI |
Correspondent |
SHU TONG XINGHUA CO., LTD. |
WEST OF XI HUAN ROAD |
ECONOMIC DEVELOPMENT DISTRICT |
XINGHUA,
CN
225700
|
|
Correspondent Contact |
SU SONG SHI |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 07/23/2012 |
Decision Date | 04/11/2014 |
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
|
|
|