Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K012860 |
Device Name |
POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING CLAIM (<50UG/G) |
Applicant |
SGMP CO., LTD. |
198 AVENUE DE LA D'EMERALD |
SPARKS,
NV
89434
|
|
Applicant Contact |
JANNA P TUCKER |
Correspondent |
SGMP CO., LTD. |
198 AVENUE DE LA D'EMERALD |
SPARKS,
NV
89434
|
|
Correspondent Contact |
JANNA P TUCKER |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 08/24/2001 |
Decision Date | 09/21/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|