| Device Classification Name |
Latex Patient Examination Glove
|
| 510(k) Number |
K891704 |
| Device Name |
PATIENT EXAMINATION GLOVES (LATEX) |
| Applicant |
| Executive Commodities Exchange Co. |
| 2705 N. Durfee Ave. Suite E |
|
El Monte,
CA
91732
|
|
| Applicant Contact |
KENNETH CHIN |
| Correspondent |
| Executive Commodities Exchange Co. |
| 2705 N. Durfee Ave. Suite E |
|
El Monte,
CA
91732
|
|
| Correspondent Contact |
KENNETH CHIN |
| Regulation Number | 880.6250 |
| Classification Product Code |
|
| Date Received | 03/20/1989 |
| Decision Date | 04/25/1989 |
| 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
|