Device Classification Name |
vinyl patient examination glove
|
510(k) Number |
K043475 |
Device Name |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
Applicant |
SHIJIAZHUANG WINFUL PLASTIC CO., LTD. |
NO. 10B CENTRAL ROAD, AVIC BLD |
EAST 3RD RING ROAD |
CHAOYANG DISTRICT, BEIJING,
CN
10002
|
|
Applicant Contact |
CHEN YUHONG |
Correspondent |
SHIJIAZHUANG WINFUL PLASTIC CO., LTD. |
NO. 10B CENTRAL ROAD, AVIC BLD |
EAST 3RD RING ROAD |
CHAOYANG DISTRICT, BEIJING,
CN
10002
|
|
Correspondent Contact |
CHEN YUHONG |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 12/16/2004 |
Decision Date | 02/01/2005 |
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
|
|
|