Recall Z-0295-2013— Gulf South Medical Supply Inc

Name: FDA recall Z-0295-2013
Creator: U.S. Food and Drug Administration
Published: 2012-06-20

Class II · Terminated

Class II FDA medical device recall by Gulf South Medical Supply Inc, initiated 2012-06-20, terminated 2014-08-19. It names one FDA 510(k) clearance: K102152. 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.. Reason: 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..

Recalling firm: Gulf South Medical Supply Inc
Classification: Class II
Status: Terminated
Initiated: 2012-06-20
Terminated: 2014-08-19
Firm location: Jacksonville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K102152 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVESHebei Tengda Plastic Co., Ltd.·cleared 2011-04-28

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

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.

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.

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