Device Classification Name |
Vinyl Patient Examination Glove
|
510(k) Number |
K122100 |
Device Name |
POWDERED VINYL EXAMINATION GLOVES |
Applicant |
WANG TONG XINGHUA CO., LTD |
WEST OF GUO JING ROAD |
ECONOMIC DEVELOPMENT DISTRICT |
XINGHUA,
CN
225700
|
|
Applicant Contact |
GUO YANG |
Correspondent |
WANG TONG XINGHUA CO., LTD |
WEST OF GUO JING ROAD |
ECONOMIC DEVELOPMENT DISTRICT |
XINGHUA,
CN
225700
|
|
Correspondent Contact |
GUO YANG |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 07/16/2012 |
Decision Date | 08/22/2013 |
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
|
|
|