Cleared Traditional

HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops

K252941 · O&M Halyard, Inc. · General Hospital
Dec 2025
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K252941 is an FDA 510(k) clearance for the HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by O&M Halyard, Inc. (Alpharetta, US). The FDA issued a Cleared decision on December 11, 2025, 87 days after receiving the submission on September 15, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K252941 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2025
Decision Date December 11, 2025
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FXX — Mask, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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