Device Classification Name |
Vinyl Patient Examination Glove
|
510(k) Number |
K113837 |
Device Name |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES |
Applicant |
HEBEI CHANGSHENG PLASTIC PRODUCTS CO., LTD. |
NO 99, HUANGJIN AVENUE, |
JULU COUNTY |
XINGTAI, HEBEI PROVINCE,
CN
055250
|
|
Applicant Contact |
RICHARD LU |
Correspondent |
HEBEI CHANGSHENG PLASTIC PRODUCTS CO., LTD. |
NO 99, HUANGJIN AVENUE, |
JULU COUNTY |
XINGTAI, HEBEI PROVINCE,
CN
055250
|
|
Correspondent Contact |
RICHARD LU |
Regulation Number | 880.6250 |
Classification Product Code |
|
Date Received | 12/28/2011 |
Decision Date | 04/27/2012 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|