Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K960467 |
Device Name |
POWDER FREE LATEX EXAMINATION GLOVE |
Applicant |
BIOPRO, INC. |
22 DOGWOOD DR. |
CHESTER,
NJ
07930
|
|
Applicant Contact |
MURIEL G WILLICH |
Correspondent |
BIOPRO, INC. |
22 DOGWOOD DR. |
CHESTER,
NJ
07930
|
|
Correspondent Contact |
MURIEL G WILLICH |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 01/30/1996 |
Decision Date | 05/24/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|