Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K000050 |
Device Name |
TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES |
Applicant |
TOP QUALITY MFG., INC. |
3234 ELLA LN. |
NEW PORT RICHEY,
FL
34655
|
|
Applicant Contact |
ART WARD |
Correspondent |
TOP QUALITY MFG., INC. |
3234 ELLA LN. |
NEW PORT RICHEY,
FL
34655
|
|
Correspondent Contact |
ART WARD |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 01/07/2000 |
Decision Date | 07/27/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|