Z-0365-2007

Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1...

Name: Z-0365-2007 Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1...
Creator: Terang Nusa Sdn Bhd
Published: 2006-12-18
License: https://open.fda.gov/license/

Terang Nusa (Malaysia) Sdn. Bhd. / initiated 2006-12-18 / Terminated / root cause: labeling and UDI

FDA source

Terang Nusa Sdn Bhd began a recall of Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1 pair of gloves per package, 100 packages per case... on 2006-12-18. The reason FDA records is "Some of the packages labeled as latex-free actually contain latex gloves". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0365-2007
Status: Terminated
Initiated: 2006-12-18
Posted: 2007-01-25
Terminated: 2009-08-12
Recalling firm: Terang Nusa (Malaysia) Sdn. Bhd.
Product: Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1 pair of gloves per package, 100 packages per case; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malaysia
Product code: KGO Surgeon'S Gloves
Reason for recall: Some of the packages labeled as latex-free actually contain latex gloves.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Terang Nusa telephoned Medline Industries on 12/13/06 requesting them to retrieve the affected lot of size six gloves from their customers. Medline Industries notified their customers by letter dated 12/20/06, informing them of the possible latex gloves being labeled as the Neolon 2G Neoprene Surgical Gloves, and requesting them to inspect their inventories for the suspect size and lot of gloves. The accounts were instructed to complete the enclosed response questionnaire, indicating the amount of affected gloves found, and fax it back to Medline at 847-949-2643 to obtain a return goods authorization. Any questions were directed to Kathy Dunne at 847-359-1704.
Quantity in commerce: 43 cases
Distribution: Worldwide including USA, Canada, and Panama
Product codes and lots: Item number MDS207060, lot number T502554397, size 6

Product code KGO

K051563Class INuzone X2a Neoprene - Polyisoprene Powder Free Surgical Gloves Polymer and Aloe CoatedTerang Nusa Sdn Bhd / cleared 2005-06-20

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)