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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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