| Device Classification Name |
Latex Patient Examination Glove
|
| 510(k) Number |
K891856 |
| Device Name |
SUPER GLOVES PATIENT EXAM GLOVES (LATEX) |
| Applicant |
| World Wide Trade Network, Inc. |
| 180 Lisa Ln. |
|
Oldsmar,
FL
34677
|
|
| Applicant Contact |
MEL HARLIB |
| Correspondent |
| World Wide Trade Network, Inc. |
| 180 Lisa Ln. |
|
Oldsmar,
FL
34677
|
|
| Correspondent Contact |
MEL HARLIB |
| Regulation Number | 880.6250 |
| Classification Product Code |
|
| Date Received | 03/27/1989 |
| Decision Date | 09/13/1989 |
| 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
|
|
|