FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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
K Number: K251967
·
Decision Mar 18, 2026
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
606
Applicant Total
24
Review Days
265
Basic Information
- Device Name
- 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
- K Number
- K251967
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- O&M Halyard, Inc.
- Date Received
- June 26, 2025
- Decision Date
- March 18, 2026
- Product Code
- FXX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FXX | Mask, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by O&M Halyard, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K252941 | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops | Dec 11, 2025 | Substantially Equivalent |
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| K234050 | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap | Sep 16, 2024 | Substantially Equivalent |
| K240330 | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) | Aug 7, 2024 | Substantially Equivalent |
| 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 | Mar 22, 2024 | Substantially Equivalent |
| 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 | Aug 16, 2022 | Substantially Equivalent |