Z-0295-2013Class II

Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per...

Name: Z-0295-2013 Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per...
Creator: Gulf South Medical Supply Inc
Published: 2012-06-20
License: https://open.fda.gov/license/

Gulf South Medical Supply Inc / initiated 2012-06-20 / Terminated / root cause: manufacturing process

FDA source

Gulf South Medical Supply Inc began a recall of Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. Usage: Patient Examination on 2012-06-20. FDA classified it as Class II and gives the reason as "Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing them for sale". 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-0295-2013
Classification: Class II
Status: Terminated
Initiated: 2012-06-20
Posted: 2012-11-15
Terminated: 2014-08-19
Recalling firm: Gulf South Medical Supply Inc
Product: Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. Usage: Patient Examination.
Product code: LYZ Vinyl Patient Examination Glove
Reason for recall: Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing them for sale.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, PSS World Medical, sent an "URGENT RECALL NOTICE" dated June 20, 2012 via USPS to all customers that received the product. The notice described the product, problem and actions to be taken. The customers were instructed to examine their inventory, quarantine the affected lot numbers listed in this recall and return the product; If the product was further distributed, to inform their customers of the recall and request they return the affected product directly to them; and contact their Gulf South Customer Care team via telephone at 1-800-347-2456 or email to [email protected] to request a return goods authorization. If you have any questions, contact the Product Integrity Leader Quality Assurance at 904-380-4501.
Quantity in commerce: 275 cases and 17 boxes
Distribution: Nationwide distribution: USA including states of: DE, KY, LA, MD, NJ, NY, PA, TX, VA, and WV.
Product codes and lots: Lot # (for both sizes) 030212BU216995995 Medium gloves are Model # 6370, Product # 802634 Large gloves are Model # 6371, Product # 80635.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0295-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0295-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-21	2012-11-15

Product code LYZ

K102152Class IPowder-Free Vinyl Patient Examination GlovesHebei Tengda Plastic Co., Ltd. / cleared 2011-04-28

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)