FDA 510(k) clearance · back to tracker

HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)

Owens & Minor (O&M) Halyard, Inc. cleared K232820 on 2024-06-04, decision: substantially equivalent

K-number

K232820

Sponsor

Owens & Minor (O&M) Halyard, Inc.

Device

HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)

Class

Class II

Decision

Substantially Equivalent

Decision date

2024-06-04

Product code

FXX

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4040

Official FDA record

Open K232820on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.