| Device Classification Name |
Polymer Patient Examination Glove
|
| 510(k) Number |
K000143 |
| Device Name |
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED |
| Applicant |
| Industrial Clothings, Ltd. |
| 481 A, Prince Of Wales Ave. |
|
Columbo 14,
LK
14
|
|
| Applicant Contact |
SYED UMAIR AHMED |
| Correspondent |
| Industrial Clothings, Ltd. |
| 481 A, Prince Of Wales Ave. |
|
Columbo 14,
LK
14
|
|
| Correspondent Contact |
SYED UMAIR AHMED |
| Regulation Number | 880.6250 |
| Classification Product Code |
|
| Date Received | 01/18/2000 |
| Decision Date | 09/13/2000 |
| 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
|
|
|