Device Classification Name |
Vinyl Patient Examination Glove
|
510(k) Number |
K100699 |
Device Name |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
Applicant |
SHIJIAZHUANG STAR PLASTIC CO., LTD |
ROOM 1606 BLDG.1.JIANXIANG |
YUAN NO.209 BEI SI HUAN ZHO |
BEIJING,
CN
100083
|
|
Applicant Contact |
CHU XIAOAN |
Correspondent |
SHIJIAZHUANG STAR PLASTIC CO., LTD |
ROOM 1606 BLDG.1.JIANXIANG |
YUAN NO.209 BEI SI HUAN ZHO |
BEIJING,
CN
100083
|
|
Correspondent Contact |
CHU XIAOAN |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 03/11/2010 |
Decision Date | 05/20/2010 |
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
|
|
|