Derma Prene Powder-Free Synthetic Surgical Gloves (Chemotherapy Use)

• • Terminated Z-0893-2017 FDA Class II ·initiated 24 Oct 2016

  Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove.

• • Terminated Z-0413-2010 FDA Unclassified (pre-2012) ·initiated 19 May 2009 ·on shared 510(k) K984558

  Surgical gloves in hospital convenience kits may be degraded and tear during use.

• 7 recalls, same reason

  • Terminated Z-1588-2009 FDA Unclassified (pre-2012) ·initiated 1 May 2009
  • Terminated Z-1583-2009 FDA Unclassified (pre-2012) ·initiated 1 May 2009
  • Terminated Z-1586-2009 FDA Unclassified (pre-2012) ·initiated 1 May 2009
  • Terminated Z-1584-2009 FDA Unclassified (pre-2012) ·initiated 1 May 2009
  • Terminated Z-1589-2009 FDA Unclassified (pre-2012) ·initiated 1 May 2009
  • Terminated Z-1587-2009 FDA Unclassified (pre-2012) ·initiated 1 May 2009
  • Terminated Z-1585-2009 FDA Unclassified (pre-2012) ·initiated 1 May 2009

  Premature degradation which could result in tearing during use.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K984558 ↗

FDA Product Code

KGO

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Elite Powder-Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use)

  Class I

  FDA 510(k) K984559 Active Cleared 26 Feb 1999

• X-Tenda Cuff Powder Free Latex Surgical Gloves with Protein Content Labeling Claim 50 Micrograms or Less, Model Style 21

  Class I

  FDA 510(k) K003895 Active Cleared 17 Jan 2001

• Dermaclean X-Am (Protein Labeling Claim) Examination Gloves

  Class I

  FDA 510(k) K971424 Active Cleared 4 Jun 1997

• Derma Prene Powder-Free Synthetic Surgical Gloves

  Class I

  FDA 510(k) K980929 Active Cleared 5 Jun 1998

• Elite Mark IV Powder Free Polyurethane Synthetic Surgical Glove

  Class I

  FDA 510(k) K981392 Active Cleared 11 May 1998

• Medi-Grip (Beige 43)Surgical Gloves

  Class I

  FDA 510(k) K980564 Active Cleared 25 Mar 1998

See all devices from Ansell Perry →