Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K002718 |
Device Name |
ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB |
Applicant |
TILLOTSON HEALTHCARE CORP. |
360 ROUTE 101 |
BEDFORD,
NH
03110 -5030
|
|
Applicant Contact |
F.W. PERRELLA |
Correspondent |
TILLOTSON HEALTHCARE CORP. |
360 ROUTE 101 |
BEDFORD,
NH
03110 -5030
|
|
Correspondent Contact |
F.W. PERRELLA |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 08/31/2000 |
Decision Date | 05/01/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|