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

No FDA recalls found in the data synced 26 Oct 2026.

510(k) Number

K213289 ↗

FDA Product Code

KGO

FDA applicant

Ansell Healthcare Products, LLC

Device Class

Class I

Regulation

21 CFR Part 878.4460

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• 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

• Modification to:micro Touch (R) Powder Free Latex Surgical Gloves, Model Style 65

  Class I

  FDA 510(k) K013603 Active Cleared 13 Nov 2001

See all devices from Ansell Healthcare Products LLC →