Ansell, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
30
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K984392ANSELL CONDOMSJuly 21, 1999
K983518LIFESTYLES XTRA PLEASUREJuly 6, 1999
K940047SPERMICIDALLY LUBRICATED CONDOMDecember 19, 1995
K953379HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVESeptember 27, 1995
K945766HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVESAugust 7, 1995
K945767POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVESMarch 2, 1995
K940046NON-LUBRICATED CONDOMJanuary 30, 1995
K940045CONDOMJanuary 30, 1995
K913766ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVESMarch 11, 1993
K914760LATEX EXAMINATION GLOVESJanuary 17, 1992
K903108PATIENT EXAM GLOVES (FINISH W/USP STARCH POWDER)August 29, 1990
K903107PATIENT EXAM GLOVES (DUSTED W/USP STARCH POWDER)August 29, 1990
K901112G.S.A. COLORED CONDOMSMarch 27, 1990
K901111NUDA (CURRENTLY CALLED ULTRA SENSITIVE)March 27, 1990
K897081ANSELL CONFORM GREEN EXAMINATION GLOVESMarch 26, 1990
K895660ANSELL DENTA GLOVESJanuary 2, 1990
K892289PATIENT EXAMINATION GLOVES (LATEX)June 23, 1989
K892288PATIENT EXAMINATION GLOVES (LATEX)June 9, 1989
K892325NON-STERILE EXAM GLOVESMay 31, 1989
K892106STERILE EXAM GLOVESMay 31, 1989