Encore Sterile Powder-Free Latex Surgical Glove with Proprietary Coating (Containing Glycerine)

• 8 recalls, same reason

  • Terminated Z-2847-2011 FDA Unclassified (pre-2012) ·initiated 10 Jun 2011 ·on shared 510(k) K051793
  • Terminated Z-2845-2011 FDA Unclassified (pre-2012) ·initiated 10 Jun 2011 ·on shared 510(k) K051793
  • Terminated Z-2844-2011 FDA Unclassified (pre-2012) ·initiated 10 Jun 2011 ·on shared 510(k) K051793
  • Terminated Z-2841-2011 FDA Unclassified (pre-2012) ·initiated 10 Jun 2011 ·on shared 510(k) K051793
  • Terminated Z-2842-2011 FDA Unclassified (pre-2012) ·initiated 10 Jun 2011 ·on shared 510(k) K051793
  • Terminated Z-2846-2011 FDA Unclassified (pre-2012) ·initiated 10 Jun 2011 ·on shared 510(k) K051793
  • Terminated Z-2840-2011 FDA Unclassified (pre-2012) ·initiated 10 Jun 2011 ·on shared 510(k) K051793
  • Terminated Z-2843-2011 FDA Unclassified (pre-2012) ·initiated 10 Jun 2011 ·on shared 510(k) K051793

  Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.

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

510(k) Number

K051793 ↗

FDA Product Code

KGO

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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