Device Classification Name |
latex patient examination glove
|
510(k) Number |
K093496 |
Device Name |
NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT |
Applicant |
OON CORP. RESOURCES |
198 AVE. DE LA DEMERALD |
SPARKS,
NV
89434 -9550
|
|
Applicant Contact |
JANNA P TUCKER |
Correspondent |
OON CORP. RESOURCES |
198 AVE. DE LA DEMERALD |
SPARKS,
NV
89434 -9550
|
|
Correspondent Contact |
JANNA P TUCKER |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 11/10/2009 |
Decision Date | 02/03/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|