Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K004018 |
Device Name |
SKINGARD POLYCOAT GLOVE |
Applicant |
TOP QUALITY MFG., INC. |
962 ALLEGRO LN. |
APOLLO BEACH,
FL
33572
|
|
Applicant Contact |
ART WARD |
Correspondent |
TOP QUALITY MFG., INC. |
962 ALLEGRO LN. |
APOLLO BEACH,
FL
33572
|
|
Correspondent Contact |
ART WARD |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 12/27/2000 |
Decision Date | 05/11/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|