| Device Classification Name |
Latex Patient Examination Glove
|
| 510(k) Number |
K902708 |
| Device Name |
SAFETY FIRST |
| Applicant |
| Bright Rubber Industries Private , Ltd. |
| B-80 To 84,Sector 8 |
| Noida, Ghaziabad, U.P. |
|
India,
IN
|
|
| Applicant Contact |
BHATTACHARYYA |
| Correspondent |
| Bright Rubber Industries Private , Ltd. |
| B-80 To 84,Sector 8 |
| Noida, Ghaziabad, U.P. |
|
India,
IN
|
|
| Correspondent Contact |
BHATTACHARYYA |
| Regulation Number | 880.6250 |
| Classification Product Code |
|
| Date Received | 06/20/1990 |
| Decision Date | 09/05/1990 |
| 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
|
|
|