Recall Z-0758-2017— Halyard Health

Name: FDA recall Z-0758-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-10

Class II · Terminated

Class II FDA medical device recall by Halyard Health, initiated 2016-11-10, terminated 2017-05-04. It names one FDA 510(k) clearance: K081027. Product: Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.. Reason: Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing..

Recalling firm: Halyard Health
Classification: Class II
Status: Terminated
Initiated: 2016-11-10
Terminated: 2017-05-04
Firm location: Roswell, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K081027 — KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE)Kimberly-Clark Corp.·cleared 2008-06-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.

Data sourced from openFDA. This site is unofficial and independent of the FDA.