Powder-Free Nitrile Patient Chemotherapy Examination Glove, Blue Colored

• 4 recalls, same reason

  • Terminated Z-3116-2011 FDA Unclassified (pre-2012) ·initiated 4 Aug 2011
  • Terminated Z-3115-2011 FDA Unclassified (pre-2012) ·initiated 4 Aug 2011
  • Terminated Z-3117-2011 FDA Unclassified (pre-2012) ·initiated 4 Aug 2011
  • Terminated Z-3114-2011 FDA Unclassified (pre-2012) ·initiated 4 Aug 2011

  Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.

510(k) Number

K032374 ↗

FDA Product Code

LZC

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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