| 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 Bldg., 1 Jian Xiang |
| Yuan # 209 Bei Si Huan Zhong |
|
Road Hai Di, Beijing,
CN
100083
|
|
| Applicant Contact |
CHU XIAOAN |
| Correspondent |
| Hongxin Plastic Products Co., Ltd. |
| Rm.1606 Bldg., 1 Jian Xiang |
| Yuan # 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
|
Predetermined Change Control Plan Authorized |
No
|
|
|