Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K000156 |
Device Name |
SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES |
Applicant |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
198 AVENUE DE LA D'EMERALD |
SPARKS,
NV
89434 -9550
|
|
Applicant Contact |
JANNA P TUCKER |
Correspondent |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
198 AVENUE DE LA D'EMERALD |
SPARKS,
NV
89434 -9550
|
|
Correspondent Contact |
JANNA P TUCKER |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 01/19/2000 |
Decision Date | 02/18/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|