Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for U

• 2 recalls, same reason

  • Ongoing Z-0096-2024 FDA Class II ·initiated 3 Aug 2023
  • Ongoing Z-0097-2024 FDA Class II ·initiated 3 Aug 2023

  Some surgical glove sterile pouches were not completely sealed.

• • Ongoing Z-0838-2022 FDA Class II ·initiated 19 Feb 2022

  Transport company failed to stop at the border for required FDA inspection.

510(k) Number

K111139 ↗

FDA Product Code

KGO

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs

  Class I

  FDA 510(k) K213289 Active Cleared 26 May 2023

• Micro-Touch Nitrile

  Class I

  FDA 510(k) K093523 Active Cleared 4 Mar 2010

• Micro-Touch Nitrafree

  Class I

  FDA 510(k) K080536 Active Cleared 19 Jun 2008

• Micro-Touch Nitra Free

  Class I

  FDA 510(k) K092327 Active Cleared 21 Sep 2009

• Gammex Cut-Resistant Glove Liner

  Class I

  FDA 510(k) K160974 Active Cleared 28 Oct 2016

• Gammex PI Hybrid Surgical Gloves

  Class I

  FDA 510(k) K151694 Active Cleared 9 Mar 2016

See all devices from Ansell Healthcare Products LLC →