| Device Classification Name |
Latex Patient Examination Glove
|
| 510(k) Number |
K891018 |
| Device Name |
LATEX PATIENT EXAMINATION GLOVE |
| Applicant |
| U.S. Medical Supply, Inc. |
| 281 Glen St. |
|
Glencove,
NY
11542
|
|
| Applicant Contact |
J HACKETT |
| Correspondent |
| U.S. Medical Supply, Inc. |
| 281 Glen St. |
|
Glencove,
NY
11542
|
|
| Correspondent Contact |
J HACKETT |
| Regulation Number | 880.6250 |
| Classification Product Code |
|
| Date Received | 02/28/1989 |
| Decision Date | 08/18/1989 |
| 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
|
|
|