Device Classification Name |
Vinyl Patient Examination Glove
|
510(k) Number |
K120358 |
Device Name |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
Applicant |
HONGXIN PLASTIC PRODUCTS CO., LTD |
RM 1606 BUILDING, 1 JIAN XIANG |
YUAN NO. 209 BEI SI HUAN ZHONG |
ROAD HAI DI, BEIJING,
CN
100083
|
|
Applicant Contact |
CHU XIAOAN |
Correspondent |
HONGXIN PLASTIC PRODUCTS CO., LTD |
RM 1606 BUILDING, 1 JIAN XIANG |
YUAN NO. 209 BEI SI HUAN ZHONG |
ROAD HAI DI, BEIJING,
CN
100083
|
|
Correspondent Contact |
CHU XIAOAN |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 02/06/2012 |
Decision Date | 03/06/2012 |
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
|
|
|