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FDA 510(k)

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)

K-Number: K253398 · 2026-02-19

ApplicantEfofex, Inc.
Decision Date2026-02-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) is a medical device manufactured by Efofex, Inc.. It received FDA 510(k) clearance on 2026-02-19 under approval number K253398. 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 Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)?

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) is a medical device that received FDA 510(k) clearance on 2026-02-19. It is manufactured by Efofex, Inc.. The 510(k) number is K253398.

When was Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) approved by the FDA?

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) received FDA 510(k) clearance on 2026-02-19, under approval number K253398.

What company makes Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)?

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) is manufactured by Efofex, Inc..

What is the FDA product code for Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)?

The FDA product code for Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) is FXX.

Related Clinical Trials

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Other Devices by Efofex, Inc.

K223823Disposable Surgical Face Mask

Related Devices (Code: FXX)

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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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