Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K002176 |
Device Name |
NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS LE |
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 | 07/19/2000 |
Decision Date | 07/31/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|