O&M Halyard, Inc.
FDA 510(k) & PMA Approved Devices — 23 products
Total Devices23
Categories6
Latest Approval2026-03-18
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K251967 | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor | FXX | 2026-03-18 | View |
| 510(k) | K252941 | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops | FXX | 2025-12-11 | View |
| 510(k) | K243604 | 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 | LZA | 2025-08-18 | View |
| 510(k) | K243172 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles | LZA | 2025-06-18 | View |
| 510(k) | K242558 | 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 | LZA | 2024-12-17 | View |
| 510(k) | K241909 | 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 | LZA | 2024-09-27 | View |
| 510(k) | K234050 | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap | FRG | 2024-09-16 | View |
| 510(k) | K240330 | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) | FRG | 2024-08-07 | View |
| 510(k) | K231938 | 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 | LZA | 2024-03-22 | View |
| 510(k) | K213937 | 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 | LZA | 2022-08-16 | View |
| 510(k) | K213929 | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | LZA | 2022-08-01 | View |
| 510(k) | K220541 | PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves | LZA | 2022-06-02 | View |
| 510(k) | K220547 | PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves | LZA | 2022-06-02 | View |
| 510(k) | K203177 | Sterisystem Dry-Base Instrument Tray | KCT | 2022-01-02 | View |
| 510(k) | K211063 | HALYARD Flexaprene Green Powder-Free Exam Glove | LZA | 2021-11-19 | View |
| 510(k) | K210688 | AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown | FYA | 2021-07-21 | View |
| 510(k) | K202622 | Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate | LZA | 2021-01-07 | View |
| 510(k) | K200843 | Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs | LZA | 2020-09-22 | View |
| 510(k) | K200522 | AERO CHROME* Breathable Performance Surgical Gowns | FYA | 2020-03-16 | View |
| 510(k) | K192362 | Aero Blue Performance Surgical Gowns | FYA | 2019-12-13 | View |
| 510(k) | K191230 | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves | LZC | 2019-11-08 | View |
| 510(k) | K182851 | SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | LZA | 2019-06-26 | View |
| 510(k) | K183132 | Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | LZC | 2019-02-05 | View |
No matching devices.