FDA 510(k) Applications Submitted by O&M Halyard, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K220541 02/25/2022 PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves O&M Halyard, Inc.
K220547 02/25/2022 PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves O&M Halyard, Inc.
K192362 08/30/2019 Aero Blue Performance Surgical Gowns O&M Halyard, Inc.
K200843 03/31/2020 Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs O&M Halyard, Inc.


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