O&M Halyard, Inc.

FDA Device Registration & Listing · Alpharetta, GA, US · Registration 3014421917

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014421917
FEI Number
3014421917
Entity Name
O&M Halyard, Inc.
City/State/Country
Alpharetta, GA, US
Establishment Address
1220 Old Alpharetta Rd Ste 320, Alpharetta, GA 30005, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
O&M Halyard, Inc. (Owner Number: 10057479)
Owner / Operator Contact Address
1220 Old Alpharetta Rd, Suite 320, Alpharetta, GA 30005, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SKYBREEZE* Powder-Free Nitrile Exam Gloves HALYARD® SEQUENTIAL Sterilization Wrap HALYARD® ONE-STEP® Sterilization Wrap HALYARD® QUICK CHECK® Sterilization Wrap HALYARD® SMART-FOLD® Sterilization Wrap YK9000 SERIES MANUAL WHEELCHAIR POLYMER PATIENT EXAM GLOVE CRUTCH Sterling Nitrile Powder-Free Exam Gloves HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops, WrapAround Visor HALYARD Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining HALYARD Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with Visor HALYARD Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor HALYARD Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor HALYARD Fluidshield * 3 Surgical Mask with SO SOFT* Lining 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, WrapAround Visor AMSafe(R) Pre-Filled Normal Saline Flush Syringe POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED Personal Stirrup Strap with Slip Ring AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Blue, WrapAround Visor HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Blue PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves Polyisoprene/Neoprene Hybrid Sterile Surgical Glove HALYARD* AQUASOFT ZERO* Nitrile Exam Gloves STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE STERILIZATION WRAP SURGICAL GOWN Personal Stirrup Strap with Slip Ring SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE Tri-Layer AAMI 3 Isolation Gowns SPLINT, HAND AND COMPONENTS Vinyl patient examination glove Obstetric-gynecologic specialized manual instrument (Clamp, Umbilical) TUBE, ASPIRATING, FLEXIBLE, CONNECTING Curaplex® TritonGrip VL™ Nitrile Exam Gloves BASICS* Blue Powder-Free Nitrile Exam Gloves Disposable Powder Free Nitrile Examination Glove, White Color, Tested for Use with Chemotherapy Drugs, Disposable Powder Cover, Limb Needle, hypodermic, single lumen Syringe, piston SURGICAL DRAPE Surgical Packs PATIENT RESTRAINT Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove SURGICAL DRAPE Surgical Packs BANDAGE, ELASTIC POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE FLEXAPRENE GREEN POWDER-FREE EXAM GLOVES SYRINGE, IRRIGATING (NON DENTAL) STERILIZATION WRAP VINYL PATIENT EXAMINATION GLOVE-POWDER FREE Latex Powder-Free Sterile Surgical Gloves Tested for use with Chemothera STERILIZATION WRAP AND ACCESSORIES Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested With Chemotherapy Drugs Halyard Purple Nitrile* Powder-Free Exam Gloves Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fenta Aero Chrome Select White Powder-Free Nitrile PPE Exam Gloves NITRILE POWDER FREE EXAMINATION GLOVES POLYMER PATIENT EXAM GLOVE FLUID CONTROL* Floor Suction Mat Halyard Surgical N95 Respirator Cup Type Small Size Halyard Surgical N95 Respirator Cup Type Regular Size STERILE LUBRICATING JELLY SMART-FOLD Sterilization Wrap HALYARD GOWN Aero Chrome Breathable Performance Surgical Gown DISPOSABLE HOT / COLD PACK FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask LiquiBand Exceed POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF STETHOSCOPE, MANUAL Tips and pads, cane, crutch and walker solvent, adhesive tape Neoprene Micro Powder-Free Sterile Surgical Gloves SURGICAL DRAPE Surgical Packs SURGICAL GOWN Procedure Mask Surgical Mask STERILIZATION WRAP Gauze / sponge,nonresorbable for external use POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE Fetal Monitor Security Strap with Buttonhole Attachment HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED NON-STERILE DISPOSABLE VAGINAL SPECULUM Polyisoprene Powder-Free Sterile Surgical Gloves Dressing, wound, occlusive HALYARD* Non-Bordered Silicone Foam Dressing TOURNIQUET, NONPNEUMATIC Tray, catheterization, sterile urethral, with or without catheter (kit) Walker, mechanical POLYMER PATIENT EXAMINATION GLOVE HALYARD* PUREZERO* Black Nitrile Examination Gloves STERILIZATION WRAP Foam Patient Positioning TRAY, SURGICAL, INSTRUMENT ASTM Fluid-Rated Procedure Mask HALYARD* STERLING Nitrile Powder-Free Exam Gloves NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS MediChoice THERMAL REGULATING SYSTEM Latex Micro Powder-Free Sterile Surgical Gloves HALYARD* Level 1 Procedure Mask (48388) HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867) Regard® Polyisoprene Powder-Free Sterile Surgical Gloves SURGICAL MASK FLUIDSHIELD* 2 Expanded Chamber Surgical Mask with SO SOFT* Lining, High Clarity WrapAround Visor FLUIDSHIELD* 2 Expanded Chamber Surgical Mask with SO SOFT* Lining SURGICAL CAP Specimen transport and storage container (Container, Specimen, Non-Sterile) Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) EXAMINATION GOWN Evolution AAMI 4 Surgical Gown Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs Impervious Stockinette HALYARD* Xeroform Dressing Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gast HALYARD* Conforming Skin Barrier Ring HALYARD* Skin Barrier Arc One Half Circle HALYARD* Skin Barrier Ostomy Powder Halyard Lavender Nitrile Powder-Free Exam Gloves Regard® Latex Powder-Free Sterile Surgical Gloves FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) 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) Scatter Radiation Drape PEDIATRIC / CHILD FACEMASK POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE EYE SHIELD SURGICAL GOWN K160709 CATHETERS, SUCTION, TRACHEOBRONCHIAL 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 and WrapAround Visor (62116) 62115 HALYARD* FLUIDSHIELD* Level 2 Procedure Mask Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115) CONTAINER, SPECIMEN, STERILE Anti-Fog Surgical Mask STERILIZATION WRAP FLUID WARMER Sterilization Monitoring Products INSTRUMENT, SURGICAL, DISPOSABLE MediChoice THERMAL REGULATING SYSTEM STERILIZATION WRAP Halyard Pink Underguard Nitrile Powder-Free Exam Glove STERILIZATION WRAP HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim SURGICAL TABLE CUSHION Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs POLYMER PATIENT EXAM GLOVE TUBE-CONTROL PLUS with Hydrogel HALYARD* Disposable Underpad Sterilization Pouch Heat Seal-Flat Pack Tape Strips HALYARD* SMART-FOLD* Sterilization Wrap (H650) HALYARD* SMART-FOLD* Sterilization Wrap (H450) SURGICAL MASK K823078 SURGICAL MASK FLUIDSHIELD* 2 Procedure Mask with SO SOFT* Earloops FLUIDSHIELD* 2 Fog-Free Procedure Mask with SO SOFT* Earloops, Blue, WrapAround Visor FLUIDSHIELD* 2 Fog-Free Surgical Mask, Blue with Orange Print FLUIDSHIELD* 2 Fog-Free Surgical Mask, Blue with Orange Print, WrapAround Visor FLUIDSHIELD* 2 Procedure Mask with SO SOFT* Earloops, Blue Fluidshield* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Orange AERO BLUE SURGICAL GOWN HALYARD* Gelling Fiber (CMC) Dressing HALYARD* Alginate Dressing Sterilization Monitoring Products GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE OPERATING ROOM SHOE COVER Halyard ONE-STEP Sterilization Wrap POLYMER PATIENT EXAM GLOVE PATIENT EXAMINATION GLOVE, SPECIALTY SKYBREEZE* Powder-Free Nitrile Exam Gloves Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) SURGICAL SUIT PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim Telemetry Unit Pouch STERILIZATION WRAP HALYARD* Lubricating Deodorant Clear Unscented SkyBreeze Zero Nitrile Powder-Free Exam Glove container, liquid medication, graduated HALYARD* STERLING SG* Nitrile Powder-Free Exam Gloves ASTM Fluid-Rated Fog-Free Procedure Mask ASTM Fluid-Rated Procedure Mask Bandage, liquid, skin protectant SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE HALYARD* Black Powder-Free Nitrile Exam Gloves Standard Cone Mask sling, arm STERILIZATION WRAP HALYARD* Regional Anesthesia Pain Management Drape SURGICAL GOWN GOWN, DRAPE PACKS SURGICAL DRAPE HALYARD Medical adhesive tape and adhesive bandage (Tape and Bandage, Adhesive) Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves SAFESKIN NITRILE EXAM GLOVE Halyard STERLING* Powder-Free Nitrile Exam Gloves HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) PUREZERO Ultra Violet Nitrile Exam Glove Skybreeze Powder-Free Nitrile Exam Glove Kit, surgical instrument, disposable Vinyl patient examination glove HALYARD PROCEDURE GOWN ANESTHESIA BREATHING CIRCUIT Gauze/sponge, internal, x-ray detectable Gauze / sponge,nonresorbable for external use TRI-LAYER AAMI3 OVER-THE-HEAD ISOLATION GOWN CANE POLYMER PATIENT EXAMINATION GLOVE STERILIZATION WRAP

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-05-10
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2023-05-10
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2024-09-26
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2025-01-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-05-02
IPR Crutch Physical Medicine Class 1 890.3150 2025-01-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2026-03-02
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2026-03-02
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-01-09
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2025-06-27
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-09
NGT Saline, Vascular Access Flush General Hospital Class 2 880.5200 2021-08-16
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-01-14
ISH Component, External, Limb, Ankle/Foot Physical Medicine Class 1 890.3420 2023-06-19
CAE Airway, Oropharyngeal, Anesthesiology Anesthesiology Class 1 868.5110 2025-01-14
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2018-06-28
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2025-07-11
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-07-11
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2026-04-07
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2021-01-14
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-01-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-01-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-03-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-01-28
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-01-28
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-01-28
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-01-14
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-06-20
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-07-11
ITC Stirrup, External Brace Component Physical Medicine Class 1 890.3410 2023-07-14
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2025-01-14
FYC Gown, Isolation, Surgical General, Plastic Surgery Class 2 878.4040 2024-05-17
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2018-05-02
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2025-01-14
HFW Clamp, Umbilical Obstetrics/Gynecology Class 2 884.4530 2025-01-13
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2025-01-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-01-28
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-05-10
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-01-14
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-01-14
IPM Cover, Limb Physical Medicine Class 1 890.3025 2024-07-15
FMF Syringe, Piston General Hospital Class 2 880.5860 2025-01-14
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2025-01-14
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2018-05-31
NZD Stretcher, Patient Restraint General Hospital Class 1 880.6900 2018-05-02
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2021-06-29
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-06-29
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-06-29
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2018-05-31
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-12-11
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-12-11
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-12-11
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-12-11
FQM Bandage, Elastic General Hospital Class 1 880.5075 2025-01-13
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-01-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2023-12-01
GCD Connector, Catheter General, Plastic Surgery Class 1 878.4200 2025-07-09
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2025-01-13
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2023-02-01
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-09
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-02
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2025-01-14
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2025-07-09
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-03-07
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-03-07
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2018-05-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-11-03
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-11-03
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2020-11-03
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-01-28
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-01-28
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-01-28
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-01-28
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2025-07-09
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2021-08-13
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-04-17
LGM Chamber, Patient Isolation General Hospital Class 2 880.5450 2023-02-20
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2025-07-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-05-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-05-02
KES Coverslips, Microscope Slide Pathology Class 1 864.3010 2025-07-09
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2023-06-19
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2025-03-07
KMJ Lubricant, Patient General Hospital Class 1 880.6375 2025-01-14
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2020-01-07
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-18
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2020-03-17
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2018-05-02
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2024-01-23
MPN Tissue Adhesive For The Topical Approximation Of Skin General, Plastic Surgery Class 2 878.4010 2025-01-14
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2023-03-30
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-01-14
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2025-01-14
FOX Stand, Infusion General Hospital Class 1 880.6990 2025-07-09
INP Tips And Pads, Cane, Crutch And Walker Physical Medicine Class 1 890.3790 2025-01-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-09
KOX Solvent, Adhesive Tape General, Plastic Surgery Class 1 878.4730 2025-01-14
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2025-07-11
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-03-07
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2018-05-31
OHY Pill Crusher/Cutter General Hospital Class 1 880.6430 2025-07-09
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2022-12-08
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2023-02-07
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-02
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2025-01-13
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-01-14
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2025-07-09
ISR Band Or Belt, Pelvic Support Physical Medicine Class 1 890.3025 2024-02-23
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2024-01-23
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-01-14
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2025-01-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-03-07
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2025-01-14
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-07-09
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2025-01-13
KMI Monitor, Bed Patient General Hospital Class 1 880.2400 2025-07-09
FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) Gastroenterology, Urology Class 2 876.5130 2025-01-14
ITJ Walker, Mechanical Physical Medicine Class 1 890.3825 2025-01-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-05-02
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-02-21
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-02-21
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-02-21
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-02-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-07-09
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2023-02-07
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-02
BYZ Trap, Sterile Specimen General Hospital Class 2 880.6740 2025-07-09
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2022-08-05
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-01-13
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2023-12-13
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-03-18
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-03-18
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-03-18
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2025-07-11
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2021-09-01
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2021-09-01
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2018-05-02
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-03-07
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2024-07-29
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2025-07-09
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2023-01-30
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-12-11
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-12-11
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-12-11
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-12-11
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 2018-05-02
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2025-01-13
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-01-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-01-14
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2025-07-11
FME Gown, Examination General Hospital Class 1 880.6265 2018-05-02
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2025-05-27
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-04-18
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-04-18
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-09
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2022-11-02
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2025-07-09
FRO Dressing, Wound, Drug Unknown Class U N/A 2025-03-26
INB Attachment, Commode, Wheelchair Physical Medicine Class 1 890.3920 2025-07-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-08-03
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2022-08-03
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2022-08-03
EZS Appliance, Colostomy, Disposable Gastroenterology, Urology Class 1 876.5900 2024-09-24
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-08-22
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2022-08-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-08-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2023-01-30
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2024-07-29
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2023-01-31
OXZ Pediatric/Child Facemask General, Plastic Surgery Class 2 878.4040 2018-05-02
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2025-01-14
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2018-05-02
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2025-07-09
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-05-02
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2025-01-14
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2024-07-29
EFW Toothbrush, Manual Dental Class 1 872.6855 2025-07-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-06-28
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-06-28
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2025-01-14
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2022-12-08
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-02
LHC Warmer, Irrigation Solution Physical Medicine Class 1 890.5950 2021-11-30
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2023-04-05
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2025-01-13
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2018-05-02
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-02
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-01-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-01-09
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-02
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2025-12-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-06-03
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-06-03
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2022-06-03
LWG Surgical Table Cushion General, Plastic Surgery Class 1 878.4950 2018-05-02
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-03-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-03-25
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-05-02
JCY Catheter, Infusion General, Plastic Surgery Class 1 878.4200 2023-06-19
EYQ Garment, Protective, For Incontinence Gastroenterology, Urology Class 1 876.5920 2021-08-06
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2023-02-03
KGT Drape, Adhesive, Aerosol General, Plastic Surgery Class 1 878.4380 2022-11-02
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2025-07-09
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2018-04-27
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2024-08-09
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2018-05-02
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2025-03-26
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2023-04-05
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2023-04-05
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-09
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2025-01-13
FXP Cover, Shoe, Operating-Room General, Plastic Surgery Class 1 878.4040 2018-05-02
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2020-01-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-07-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-05-02
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2018-05-02
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-07-09
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-04-17
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-04-17
FXO Suit, Surgical General, Plastic Surgery Class 1 878.4040 2018-05-02
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2022-06-03
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-06-03
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-06-03
DSW Bag, Polymeric Mesh, Pacemaker Cardiovascular Class 1 870.3650 2024-02-23
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-02
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2023-02-07
PSH Percutaneous Replacement Gastrostomy Tube Kit Gastroenterology, Urology Class 2 876.5980 2025-07-11
GDS Bag, Stomal Gastroenterology, Urology Class 1 876.5900 2024-09-24
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2020-01-09
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2020-01-09
KYW Container, Liquid Medication, Graduated General Hospital Class 1 880.6430 2025-01-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-01-28
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-01-28
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2025-01-28
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-01-28
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2023-05-22
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2025-07-09
NEC Bandage, Liquid, Skin Protectant General Hospital Class 1 880.5090 2025-01-14
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2025-01-14
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-01-23
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2025-01-23
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-01-23
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2022-09-19
ILI Sling, Arm Physical Medicine Class 1 890.3640 2025-01-14
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-06-20
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2024-03-18
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2018-05-02
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2025-07-09
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2025-01-13
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-03-25
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-03-25
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-03-25
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-03-25
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2024-07-29
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2022-04-21
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-04-21
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2025-01-13
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2025-01-14
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2018-05-18
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2025-01-10
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2025-01-14
FYC Gown, Isolation, Surgical General, Plastic Surgery Class 2 878.4040 2023-06-20
IPS Cane Physical Medicine Class 1 890.3075 2025-01-14
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2025-07-11
FPD Tube, Feeding Gastroenterology, Urology Class 2 876.5980 2025-07-11
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2018-05-02
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-05-02
HDJ Scissors, Umbilical Obstetrics/Gynecology Class 1 884.4520 2025-07-09

Official Correspondent

Angela Bunn

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

O&M Halyard, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012143814 Southaven Distribution Center Southaven, MS, US
3016849443 O&M Halyard, Inc. (La Ada de Acuna) Del Rio, TX, US
1054380 Halyard North Carolina, LLC LINWOOD, NC, US
9680646 O&M Halyard Honduras S.A de C.V. VILLANEVA Cortes, HN
3035642068 Honduras Kitting, S.A. Villanueva Cortes, HN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K212801 Hong Seng Gloves Sdn Bhd Powder free nitrile examination glove- black, non sterile 2022-01-09
K260806 Vista Industries,, LLC Nitrile Disposable Examination Gloves 2026-06-03
K011593 Ansell Healthcare Products, Inc. MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE 2001-06-21
K981039 Sri Johani Sdn. Bhd. POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) 1998-04-21
K101595 Better Care Plastic Technology Cp., Ltd. POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE 2010-08-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0035-2011 Excelsior Medical Corp 2
Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use
Z-0044-2007 Excelsior Medical Corp 2
0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex.
Z-0002-2014 King Systems Corp. 1
King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0003-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014421917. Last updated year: 2026. Please use registration number 3014421917 when referencing this establishment in official correspondence.
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