ClearanceBrief
Company · US

O&M Halyard, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2026. Name variants (Inc, Corp, punctuation) are merged.

27510(k) clearances (6 in 12 months)
8recalls (1 in 12 months)
7recalls that name a 510(k)

Product codes

CodeDeviceRecords
LZAPolymer Patient Examination Glove14
FRGWrap, Sterilization4
FXXMask, Surgical4
LZCMedical Glove, Specialty4
FYAGown, Surgical3
KKXDrape, Surgical, Antimicrobial2
FXYHood, Surgical1
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1
MSHRespirator, Surgical1
QSOMedical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 28, 2026K260310HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL); HALYARD* Procedure Gown Tested for use
O&M Halyard, Inc.
QSO
Jul 21, 2026K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
O&M Halyard, Inc.
LZA
Jul 2, 2026K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE
O&M Halyard, Inc.
FRG
May 18, 2026K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap
O&M Halyard, Inc.
FRG
Mar 18, 2026K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-
O&M Halyard, Inc.
FXX
Dec 11, 2025K252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
O&M Halyard, Inc.
FXX
Aug 18, 2025K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs,
O&M Halyard, Inc.
LZA
Jun 18, 2025K243172Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile
O&M Halyard, Inc.
LZA
Dec 17, 2024K242558Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fen
O&M Halyard, Inc.
LZA
Sep 27, 2024K241909Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fenta
O&M Halyard, Inc.
LZA
Sep 16, 2024K234050HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap
O&M Halyard, Inc.
FRG
Aug 7, 2024K240330HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)
O&M Halyard, Inc.
FRG
Mar 22, 2024K231938Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fen
O&M Halyard, Inc.
LZA
Aug 16, 2022K213937Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fent
O&M Halyard, Inc.
LZA
Aug 1, 2022K213929Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gast
O&M Halyard, Inc.
LZA
Jun 2, 2022K220547PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves
O&M Halyard, Inc.
LZA
Jun 2, 2022K220541PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves
O&M Halyard, Inc.
LZA
Jan 2, 2022K203177Sterisystem Dry-Base Instrument Tray
O&M Halyard, Inc.
KCT
Nov 19, 2021K211063HALYARD Flexaprene Green Powder-Free Exam Glove
O&M Halyard, Inc.
LZA
Jul 21, 2021K210688AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown
O&M Halyard, Inc.
FYA
Jan 7, 2021K202622Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fenta
O&M Halyard, Inc.
LZA
Sep 22, 2020K200843Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs
O&M Halyard, Inc.
LZA
Mar 16, 2020K200522AERO CHROME* Breathable Performance Surgical Gowns
O&M Halyard, Inc.
FYA
Dec 13, 2019K192362Aero Blue Performance Surgical Gowns
O&M Halyard, Inc.
FYA
Nov 8, 2019K191230Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves
O&M Halyard, Inc.
LZC
Jun 26, 2019K182851SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
O&M Halyard, Inc.
LZA
Feb 5, 2019K183132Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
O&M Halyard, Inc.
LZC

Latest recalls

DateFirm and productCodeLinked 510(k)
May 22, 2026O&M HALYARD INC
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
Open, Classified		 LZCK200019
Sep 4, 2025O&M HALYARD INC
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Open, Classified		 KKXK083234
Jan 17, 2025O&M HALYARD, INC.
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Open, Classified		 KKXK083234
Dec 20, 2024O&M HALYARD, INC.
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Open, Classified		 FXXK823078
K831148
Dec 20, 2024O&M HALYARD, INC.
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Open, Classified		 FXXK823078
K831148
Apr 2, 2024O&M HALYARD, INC.
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Open, Classified		 FXYNone listed
Sep 21, 2023O&M HALYARD, INC.
FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
Open, Classified		 MSHK974068
Sep 27, 2021O&M HALYARD INC
HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
Open, Classified		 LZCK182851
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