FDA 510(k)

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

Número K: K252941 · 2025-12-11

Data da decisão2025-12-11

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops is the device name listed in this FDA 510(k) record. The listed applicant is O&M Halyard, Inc.. It received FDA 510(k) clearance on 2025-12-11 under 510(k) number K252941. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops?

HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops is a medical device that received FDA 510(k) clearance on 2025-12-11. The listed applicant is O&M Halyard, Inc.. The 510(k) number is K252941.

When did HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops receive FDA 510(k) clearance?

HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops received FDA 510(k) clearance on 2025-12-11, under 510(k) number K252941.

Who is the listed applicant for HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops?

The FDA 510(k) record lists O&M Halyard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops?

The FDA product code for HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops is FXX.

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Fonte oficial

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