Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid

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

510(k) Number

K243604 ↗

FDA Product Code

LZA

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Halyard Sterilization Wrap

  Class II

  FDA 510(k) K253454 Active Cleared 18 May 2026

• Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid

  Class I

  FDA 510(k) K241909 Active Cleared 27 Sep 2024

• PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves

  Class I

  FDA 510(k) K220541 Active Cleared 2 Jun 2022

• HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops

  Class II

  FDA 510(k) K252941 Active Cleared 11 Dec 2025

• Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs

  Class I

  FDA 510(k) K200843 Active Cleared 22 Sep 2020

• HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)

  Class II

  FDA 510(k) K240330 Active Cleared 7 Aug 2024

See all devices from O&M Halyard, Inc. →