Z-0758-2017Class II

Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile

Name: Z-0758-2017 Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile
Creator: Halyard Health
Published: 2016-11-10
License: https://open.fda.gov/license/

Halyard Health / initiated 2016-11-10 / Terminated

FDA source

Halyard Health began a recall of Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile on 2016-11-10. FDA classified it as Class II and gives the reason as "Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0758-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-10
Posted: 2016-12-14
Terminated: 2017-05-04
Recalling firm: Halyard Health
Product: Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.
Product code: LZA Polymer Patient Examination Glove
Reason for recall: Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.
FDA root cause: Under Investigation by firm
Action: Consignees were notified by letter via Fed Ex on/about 11/10/2016.
Quantity in commerce: 59 cases
Distribution: CA, FL, GA, IA, IN, LA, MA, MN, MT, NM, OR, TX and UT.
Product codes and lots: Product Code: 53130 01 (105313001), Lot numbers: SM52741 and SM52721.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0758-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0758-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-14

Product code LZA

K081027Class IKimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile)Kimberly-Clark Corp. / cleared 2008-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)