Medical Device Manufacturer · US , Alpharetta , GA

O&M Halyard, Inc.

22 submissions · 22 cleared · Since 2019
22
Total
22
Cleared
0
Denied

O&M Halyard, Inc. — FDA 510(k) Submissions

O&M Halyard, Inc. has submitted 22 FDA 510(k) premarket notifications since 2019, of which 22 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Polymer Patient Examination Glove, Gown, Surgical, Medical Glove, Specialty, Wrap, Sterilization, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories . Use the specialty filter in the sidebar to narrow results.

22 devices
1–22 of 22
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
K252941 · FXX Mask, Surgical · General Hospital
Dec 2025 87d
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
K243604 · LZA Polymer Patient... · General Hospital
Aug 2025 270d
Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles
K243172 · LZA Polymer Patient... · General Hospital
Jun 2025 261d
Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
K242558 · LZA Polymer Patient... · General Hospital
Dec 2024 111d
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
K241909 · LZA Polymer Patient... · General Hospital
Sep 2024 88d
HALYARD? ONE-STEP? Sterilization Wrap, HALYARD? QUICK CHECK? Sterilization Wrap, HALYARD? SEQUENTIAL Sterilization Wrap and HALYARD? SMART-FOLD? Sterilization Wrap
K234050 · FRG Wrap, Sterilization · General Hospital
Sep 2024 270d
HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)
K240330 · FRG Wrap, Sterilization · General Hospital
Aug 2024 184d
Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
K231938 · LZA Polymer Patient... · General Hospital
Mar 2024 266d
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
K213937 · LZA Polymer Patient... · General Hospital
Aug 2022 243d
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
K213929 · LZA Polymer Patient... · General Hospital
Aug 2022 228d
PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves
K220541 · LZA Polymer Patient... · General Hospital
Jun 2022 97d
PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves
K220547 · LZA Polymer Patient... · General Hospital
Jun 2022 97d
Sterisystem Dry-Base Instrument Tray
K203177 · KCT Sterilization Wrap... · General Hospital
Jan 2022 433d
HALYARD Flexaprene Green Powder-Free Exam Glove
K211063 · LZA Polymer Patient... · General Hospital
Nov 2021 224d
AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown
K210688 · FYA Gown, Surgical · General Hospital
Jul 2021 135d
Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate
K202622 · LZA Polymer Patient... · General Hospital
Jan 2021 119d
Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs
K200843 · LZA Polymer Patient... · General Hospital
Sep 2020 175d
AERO CHROME* Breathable Performance Surgical Gowns
K200522 · FYA Gown, Surgical · General Hospital
Mar 2020 14d
Aero Blue Performance Surgical Gowns
K192362 · FYA Gown, Surgical · General Hospital
Dec 2019 105d
Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves
K191230 · LZC Medical Glove, Specialty · General Hospital
Nov 2019 184d
SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
K182851 · LZA Polymer Patient... · General Hospital
Jun 2019 259d
Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
K183132 · LZC Medical Glove, Specialty · General Hospital
Feb 2019 84d
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