| Device Classification Name |
Latex Patient Examination Glove
|
| 510(k) Number |
K891843 |
| Device Name |
RANK PATIENT EXAM GLOVES (MFG. INTER-CONTINENTAL) |
| Applicant |
| Worldwide Medical |
| 10 E. 39th St. Suite 1104 |
|
New York,
NY
10016
|
|
| Applicant Contact |
STANLEY PEARSON |
| Correspondent |
| Worldwide Medical |
| 10 E. 39th St. Suite 1104 |
|
New York,
NY
10016
|
|
| Correspondent Contact |
STANLEY PEARSON |
| Regulation Number | 880.6250 |
| Classification Product Code |
|
| Date Received | 03/27/1989 |
| Decision Date | 06/06/1989 |
| 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
|