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. |
| K240330 |
02/05/2024 |
HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) |
O&M Halyard, Inc. |
| K234050 |
12/21/2023 |
HALYARD« ONE-STEP« Sterilization Wrap, HALYARD« QUICK CHECK« Sterilization Wrap, HALYARD« SEQUENTIAL Sterilization Wrap and HALYARD« SMART-FOLD« Sterilization Wrap |
O&M Halyard, Inc. |
| K231938 |
06/30/2023 |
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 |
O&M Halyard, Inc. |
| K241909 |
07/01/2024 |
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 |
O&M Halyard, Inc. |
| K242558 |
08/28/2024 |
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 |
O&M Halyard, Inc. |
| K243172 |
09/30/2024 |
Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles |
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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