| Device Classification Name |
Latex Patient Examination Glove
|
| 510(k) Number |
K902459 |
| Device Name |
LATEX EXAMINATION GLOVES |
| Applicant |
| Yue XI State Farms Latex Products United Corp. |
| C/O Henchman International,Inc |
| 320 Valley Dr., 2nd Floor |
|
Brisbane,
CA
94005
|
|
| Applicant Contact |
CHIU |
| Correspondent |
| Yue XI State Farms Latex Products United Corp. |
| C/O Henchman International,Inc |
| 320 Valley Dr., 2nd Floor |
|
Brisbane,
CA
94005
|
|
| Correspondent Contact |
CHIU |
| Regulation Number | 880.6250 |
| Classification Product Code |
|
| Date Received | 06/04/1990 |
| Decision Date | 06/22/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|