Data / Medical devices / United States / O&M Halyard, Inc.
O&M Halyard, Inc.: FDA-registered device maker in Alpharetta, GA, United States, 207 510(k) clearances
O&M Halyard, Inc. is registered with the FDA (registration 3014421917) in Alpharetta, GA, United States. It lists 127 device types. The FDA files 207 510(k) clearances under its listings, the newest dated July 21, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014421917
- Address
- 1220 Old Alpharetta Rd Ste 320, Alpharetta, GA, United States, 30005
- Owner or operator
- O&M Halyard, Inc. (10057479)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 20, 2018
- Registered through
- 2026
- Brand names listed
- 62115 HALYARD* FLUIDSHIELD* Level 2 Procedure Mask, AERO BLUE SURGICAL GOWN, AID, TRANSFER, AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY, AMSafe(R) Pre-Filled Normal Saline Flush Syringe, ANESTHESIA BREATHING CIRCUIT, ASTM Fluid-Rated Fog-Free Procedure Mask, ASTM Fluid-Rated Procedure Mask and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 207.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 21, 2026 | K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| July 2, 2026 | K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology | FRG | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| May 18, 2026 | K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap | FRG | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| March 18, 2026 | 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 | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| December 11, 2025 | K252941 | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops | FXX | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| August 18, 2025 | 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 | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| June 18, 2025 | K243172 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| May 30, 2025 | K243010 | Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce | FXX | Substantially Equivalent | Owens & Minor (O&M) Halyard, Inc. | accessdata.fda.gov |
| October 16, 2024 | K242839 | Safe Secure Sterilization Pouches and Rolls | FRG | Substantially Equivalent | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | accessdata.fda.gov |
| September 27, 2024 | 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 | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| September 16, 2024 | K234050 | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap | FRG | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| August 26, 2024 | K240286 | PRIMED Surgical Masks and PRIMED Procedure Masks | FXX | Substantially Equivalent | Primed Medical Products, Inc. | accessdata.fda.gov |
| August 7, 2024 | K240330 | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) | FRG | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| July 2, 2024 | K232824 | FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) | FXX | Substantially Equivalent | Owens & Minor (O&M) Halyard, Inc. | accessdata.fda.gov |
| July 1, 2024 | K232777 | FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) | FXX | Substantially Equivalent | Owens & Minor (O&M) Halyard, Inc. | accessdata.fda.gov |
| June 21, 2024 | K232807 | Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) | FXX | Substantially Equivalent | Owens & Minor (O&M) Halyard, Inc. | accessdata.fda.gov |
| June 14, 2024 | K232812 | Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116) | FXX | Substantially Equivalent | Owens & Minor (O&M) Halyard, Inc. | accessdata.fda.gov |
| June 7, 2024 | K232806 | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) | FXX | Substantially Equivalent | Owens & Minor (O&M) Halyard, Inc. | accessdata.fda.gov |
| June 4, 2024 | K232820 | HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) | FXX | Substantially Equivalent | Owens & Minor (O&M) Halyard, Inc. | accessdata.fda.gov |
| May 24, 2024 | K233111 | ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC | FRO | Substantially Equivalent | Foshan United Medical Technologies, Ltd. | accessdata.fda.gov |
| May 16, 2024 | K232849 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) | FYC | Substantially Equivalent | Owens & Minor (O&M) Halyard, Inc. | accessdata.fda.gov |
| March 22, 2024 | K233578 | BAHADIR STERILIZATION CONTAINERS | KCT | Substantially Equivalent | Bahadir USA, LLC | accessdata.fda.gov |
| March 22, 2024 | 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 | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| January 12, 2024 | K233022 | Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small | MSH | Substantially Equivalent | Owens & Minor (O&M) Halyard, Inc. | accessdata.fda.gov |
| January 8, 2024 | K232894 | HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) | FXX | Substantially Equivalent | Owens & Minor (O&M) Halyard, Inc. | accessdata.fda.gov |
| November 14, 2023 | K232461 | Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| August 7, 2023 | K223713 | Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Better Care Plastic Technology Co., Ltd. | accessdata.fda.gov |
| May 22, 2023 | K220722 | PVC Hydrophilic Urethral Catheter | EZD | Substantially Equivalent | Well Lead Medical Co., Ltd. | accessdata.fda.gov |
| August 16, 2022 | 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 | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| August 1, 2022 | 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 | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| July 27, 2022 | K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap | FRG | Substantially Equivalent | Owens & Minor (O&M) Halyard, Inc. | accessdata.fda.gov |
| June 2, 2022 | K220547 | PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| June 2, 2022 | K220541 | PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| January 2, 2022 | K203177 | Sterisystem Dry-Base Instrument Tray | KCT | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| December 22, 2021 | K211022 | Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims. | LZA | Substantially Equivalent | Central Medicare Sdn Bhd | accessdata.fda.gov |
| November 19, 2021 | K211063 | HALYARD Flexaprene Green Powder-Free Exam Glove | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| August 19, 2021 | K211066 | Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 | FXX | Substantially Equivalent | Homtex, Inc. | accessdata.fda.gov |
| August 13, 2021 | K211969 | EMM Ultrasonic Transducer Cover | ITX | Substantially Equivalent | Exact Medical Manufacturing | accessdata.fda.gov |
| July 21, 2021 | K210688 | AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown | FYA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| March 19, 2021 | K201095 | Sovereign America Surgical Face Mask | FXX | Substantially Equivalent | Homtex, Inc. | accessdata.fda.gov |
| January 7, 2021 | K202622 | Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| October 11, 2020 | K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove | LZC | Substantially Equivalent | 0 & M Halyard, Inc. | accessdata.fda.gov |
| September 22, 2020 | K200843 | Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| June 30, 2020 | K200272 | Terragene Chemdye | JOJ | Substantially Equivalent | Terragene S.A. | accessdata.fda.gov |
| April 6, 2020 | K200019 | Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| March 16, 2020 | K200522 | AERO CHROME* Breathable Performance Surgical Gowns | FYA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| March 13, 2020 | K192241 | Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | O&M Haylard, Inc. | accessdata.fda.gov |
| December 23, 2019 | K190736 | Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs | LZA | Substantially Equivalent | Ever Growth (Vietnam) Co. , Ltd. | accessdata.fda.gov |
| December 13, 2019 | K192362 | Aero Blue Performance Surgical Gowns | FYA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| November 8, 2019 | K191230 | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves | LZC | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| October 23, 2019 | K183562 | Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | Encompass Industries Sdn. Bhd. | accessdata.fda.gov |
| October 10, 2019 | K192147 | Halyard ONE-STEP* Sterilization Wrap | FRG | Substantially Equivalent | Owens & Minor (O&M) Halyard, Inc. | accessdata.fda.gov |
| September 13, 2019 | K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye | FRC | Substantially Equivalent | Terragene S.A. | accessdata.fda.gov |
| September 6, 2019 | K190403 | Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs | LZA | Substantially Equivalent | Ever Global (Vietnam) Enterprise Corporation | accessdata.fda.gov |
| July 12, 2019 | K183473 | AMSafe(R) Pre-Filled Normal Saline Flush Syringe | NGT | Substantially Equivalent | Amsino International, Inc. | accessdata.fda.gov |
| July 4, 2019 | K183149 | Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim | LZC | Substantially Equivalent | Central Medicare Sdn Bhd | accessdata.fda.gov |
| June 26, 2019 | K182851 | SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| May 23, 2019 | K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| March 22, 2019 | K181959 | HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) | FRG | Substantially Equivalent | Owens & Minor Halyard, Inc. | accessdata.fda.gov |
| February 5, 2019 | K183132 | Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| January 22, 2019 | K181887 | AMD Anti-Fog Solution | OCT | Substantially Equivalent | Advanced Medical Design Co., Ltd. | accessdata.fda.gov |
| January 3, 2019 | K180139 | Safe Secure Sterilization Pouches and Rolls | FRG | Substantially Equivalent | Safe Secure Packing Co., Ltd. | accessdata.fda.gov |
| November 30, 2018 | K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) | LZA | Substantially Equivalent | Better Care Plastic Technology Co., Ltd. | accessdata.fda.gov |
| November 20, 2018 | K181857 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| November 2, 2018 | K182096 | Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Owens & Minor Halyard, Inc. | accessdata.fda.gov |
| June 27, 2018 | K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | Halyard Health | accessdata.fda.gov |
| March 5, 2018 | K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | Central Medicare Sdn Bhd | accessdata.fda.gov |
| December 12, 2017 | K173137 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| November 15, 2017 | K171873 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Zhonghong Pulin Medical Products Co., Ltd. | accessdata.fda.gov |
| November 2, 2017 | K163646 | Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator | FRC | Substantially Equivalent | Terragene S.A. | accessdata.fda.gov |
| August 25, 2017 | K170136 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Shandong Feiyang Professional Gloves Co., Ltd. | accessdata.fda.gov |
| July 7, 2017 | K171339 | EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs | LZA | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. | accessdata.fda.gov |
| May 2, 2017 | K160781 | Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves | KGO | Substantially Equivalent | Semperit Investments Asia Pte , Ltd. | accessdata.fda.gov |
| April 21, 2017 | K162930 | Aero Chrome* Select Breathable Performance Surgical Gowns | FYA | Substantially Equivalent | Halyard Health, Inc. | accessdata.fda.gov |
| February 27, 2017 | K163191 | ComfortGuard Surgical Gown, i600, Film Reinforced | FYA | Substantially Equivalent | Gri Medical & Electrical Technology Co., Ltd. | accessdata.fda.gov |
| February 6, 2017 | K162923 | NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| November 4, 2016 | K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3) | FYC | Substantially Equivalent | Primed Medical Products, Inc. | accessdata.fda.gov |
| November 2, 2016 | K162095 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| September 6, 2016 | K160709 | HALYARD* PURPLE NITRILE XTRA* Powder-Free Exam Gloves | LZC | Substantially Equivalent | Halyard Health | accessdata.fda.gov |
| August 4, 2016 | K153540 | Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators | FRG | Substantially Equivalent | Safe Secure Packaging Co., Ltd. | accessdata.fda.gov |
| August 3, 2016 | K151750 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| June 21, 2016 | K152246 | Aquarius Stoma Measuring Device | KNT | Substantially Equivalent | Degania Silicone , Ltd. | accessdata.fda.gov |
| April 13, 2016 | K153255 | Aero Chrome* Breathable Performance Surgical Gown | FYA | Substantially Equivalent | Halyard Health, Inc. | accessdata.fda.gov |
| March 31, 2016 | K153708 | Halyard Black-Orange Powder-Free Nitrile Exam Glove | LZA | Substantially Equivalent | Halyard Health | accessdata.fda.gov |
| March 9, 2016 | K151694 | Gammex PI Hybrid Surgical Gloves | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| October 26, 2015 | K151182 | LiquiBand Exceed | MPN | Substantially Equivalent | Advanced Medical Solutions (Plymouth), Ltd. | accessdata.fda.gov |
| June 18, 2015 | K150113 | Fusion Black Powder-Free Nitrile Exam Glove | LZA | Substantially Equivalent | Halyard Health | accessdata.fda.gov |
| April 3, 2015 | K143053 | KIMGUARD ONE-STEP Sterilization Wrap | FRG | Substantially Equivalent | Kimberly-Clark Health Care | accessdata.fda.gov |
| March 24, 2015 | K143287 | Fluidshield* Surgical Mask with Expanded Chamber | FXX | Substantially Equivalent | Halyard Health, Inc. | accessdata.fda.gov |
| March 9, 2015 | K142782 | KIMGUARD ONE-STEP Sterilization Wrap | FRG | Substantially Equivalent | Kimberly-Clark Health Care | accessdata.fda.gov |
| January 22, 2015 | K143247 | Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored) | LZA | Substantially Equivalent | Central Medicare Sdn Bhd | accessdata.fda.gov |
| January 16, 2015 | K142283 | Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color) | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| December 29, 2014 | K143378 | AQUARIUS Gastrostomy Replacement Tube | KNT | Substantially Equivalent | Degania Silicone , Ltd. | accessdata.fda.gov |
| December 18, 2014 | K141712 | KIMGUARD ONE STEP STERILIZATION WRAP | FRG | Substantially Equivalent | Halyard Health | accessdata.fda.gov |
| November 10, 2014 | K140963 | KIMGUARD SMART-FOLD STERILIZATION WRAP | FRG | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| October 28, 2014 | K142563 | Well Lead PVC Urethral Catheter | EZD | Substantially Equivalent | Well Lead Medical Co., Ltd. | accessdata.fda.gov |
| October 16, 2014 | K141753 | AQUARIUS NASAL FEEDING TUBE | PIF | Substantially Equivalent | Degania Silicone , Ltd. | accessdata.fda.gov |
| August 12, 2014 | K131407 | BAHADIR STERILIZATION TRAYS | KCT | Substantially Equivalent | Bahadir USA Corp. | accessdata.fda.gov |
| August 7, 2014 | K141612 | KIMGUARD ONE-STEP STERILIZATION WRAP | FRG | Substantially Equivalent | Kimberly-Clark Health Care | accessdata.fda.gov |
| July 28, 2014 | K141071 | KIMGUARD ONE-STEP STERILIZATION WRAP | FRG | Substantially Equivalent | Kimberly-Clark Health Care | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 13, 2026 | 98805 | Class II | Ongoing | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl) | Nitrile Exam Glove failed to meet specifications chemical permeation performance. | accessdata.fda.gov |
| July 17, 2025 | 97394 | Class II | Ongoing | Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029 | Surgical drape packs may have open seals, which may compromise the sterility of the product. | accessdata.fda.gov |
| September 27, 2021 | 88846 | Class II | Ongoing | HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL | All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing. | accessdata.fda.gov |
Compare with other makers
- All makers of Drape, Surgical, Exempt
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Updated July 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.