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FDA 510(k)

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

K-Number: K252941 · 2025-12-11

ApplicantO&M Halyard, Inc.
Decision Date2025-12-11
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by O&M Halyard, Inc.. The 510(k) number is K252941.

When was HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops approved by the FDA?

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

What company makes 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 manufactured by O&M Halyard, Inc..

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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Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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