| Device Classification Name |
Latex Patient Examination Glove
|
| 510(k) Number |
K914049 |
| Device Name |
MULTIPLE LATEX PATIENT EXAMINATION GLOVES |
| Applicant |
| London Rubber Co. (India) , Ltd. |
| 6 Cathedral Rd. |
| Madras-600 086 |
|
India,
IN
|
|
| Applicant Contact |
J SRINIVASAN |
| Correspondent |
| London Rubber Co. (India) , Ltd. |
| 6 Cathedral Rd. |
| Madras-600 086 |
|
India,
IN
|
|
| Correspondent Contact |
J SRINIVASAN |
| Regulation Number | 880.6250 |
| Classification Product Code |
|
| Date Received | 09/10/1991 |
| Decision Date | 10/23/1991 |
| 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
|
|
|