Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K210401 ↗

FDA Product Code

LZA

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

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

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