| Device Classification Name |
Latex Patient Examination Glove
|
| 510(k) Number |
K890462 |
| Device Name |
LATEX EXAMINATION GLOVE |
| Applicant |
| C.R. Trading, Inc. |
| 1314 Jadwin Ave. |
|
Richland,
WA
99352
|
|
| Applicant Contact |
GARRY L QUINN |
| Correspondent |
| C.R. Trading, Inc. |
| 1314 Jadwin Ave. |
|
Richland,
WA
99352
|
|
| Correspondent Contact |
GARRY L QUINN |
| Regulation Number | 880.6250 |
| Classification Product Code |
|
| Date Received | 01/30/1989 |
| Decision Date | 03/24/1989 |
| 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
|
|
|