HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops +1 more— 510(k) K251967
Substantially EquivalentO&M Halyard, Inc.
FDA 510(k) clearance K251967 for HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops +1 more, Substantially Equivalent on 2026-03-18. Applicant: O&M Halyard, Inc.. Device class: 2.
Clearance details
- Device name as filed
- 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
- Applicant
- O&M Halyard, Inc.
- Product code
- Code FXX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
Recent devices under product code FXX
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view all- K262014 — PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
- K261897 — HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology +3 more
- K253454 — HALYARD* ONE-STEP* Sterilization Wrap +3 more
- K252941 — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
- 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
Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.