Z-0679-2012

Zee Clear Vinyl Medical Examination Gloves, Powder Free, Medium, Non-Sterile; 100 gloves per box, 10 boxes...

Name: Z-0679-2012 Zee Clear Vinyl Medical Examination Gloves, Powder Free, Medium, Non-Sterile; 100 gloves per box, 10 boxes...
Creator: Cypress Medical Products LLC
Published: 2011-11-15
License: https://open.fda.gov/license/

Cypress Medical Products LLC / initiated 2011-11-15 / Terminated / root cause: manufacturing process

FDA source

Cypress Medical Products LLC began a recall of Zee Clear Vinyl Medical Examination Gloves, Powder Free, Medium, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine... on 2011-11-15. The reason FDA records is "The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0679-2012
Status: Terminated
Initiated: 2011-11-15
Posted: 2012-01-11
Terminated: 2012-10-08
Recalling firm: Cypress Medical Products LLC
Product: Zee Clear Vinyl Medical Examination Gloves, Powder Free, Medium, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA 92606, Made in China; Zee Part No.: 3061 Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants
Product code: LYZ Vinyl Patient Examination Glove
Reason for recall: The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Cypress Medical telephoned the accounts and then sent Urgent Voluntary Medical Device Recall letters dated November 14, 2011, to all affected customers. The letter informed them that the lot of gloves did not meet certain release specifications and that some of the gloves may not provide an effective barrier to infectious material. Customers were requested to cease distribution of the affected product, quarantine the gloves, and contact Cypress Medical's customer service department at 800-334-3646 for a returned goods authorization, return instruction and credit. The accounts were also requested to notify their customers of the recall, and to complete and return the enclosed reply form. For questions regarding this recall call 815-385-0100.
Quantity in commerce: 280 cases
Distribution: Nationwide Distribution including California, Indiana, New York and Texas
Product codes and lots: Zee Part No.: 3061, lot number CZA04-22

Product code LYZ

K093264Class IVinyl Examination Glove, Powder Free, Non-ColoredQingdao Lang Hui Import & Export Co., Ltd. / cleared 2010-05-28

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)