Device Classification Name |
latex patient examination glove
|
510(k) Number |
K000165 |
Device Name |
NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM |
Applicant |
ANSELL PERRY |
1875 HARSH AVE. S.E. |
MASSILLON,
OH
44646 -7199
|
|
Applicant Contact |
JAMES R CHATTERTON |
Correspondent |
ANSELL PERRY |
1875 HARSH AVE. S.E. |
MASSILLON,
OH
44646 -7199
|
|
Correspondent Contact |
JAMES R CHATTERTON |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 01/19/2000 |
Decision Date | 03/10/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|