ClearanceBrief
Recall Z-0758-2017 ยท LZA Polymer Patient Examination Glove

Halyard Health

Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.

DateDec 14, 2016 (initiated Nov 10, 2016)
StatusTerminated
ReasonDefects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.
Root causeUnder Investigation by firm
ActionConsignees were notified by letter via Fed Ex on/about 11/10/2016.
Quantity59 cases
DistributionCA, FL, GA, IA, IN, LA, MA, MN, MT, NM, OR, TX and UT.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K081027KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE)
Kimberly-Clark Corp., Jun 30, 2008