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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 the device name listed in this FDA 510(k) record. The listed applicant is Efofex, Inc.. It received FDA 510(k) clearance on 2026-02-19 under 510(k) 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. The listed applicant is Efofex, Inc.. The 510(k) number is K253398.

When did Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) receive FDA 510(k) clearance?

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

Who is the listed applicant for Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)?

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

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.

Other records listing Efofex, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223823Disposable Surgical Face Mask

Related Devices (Code: FXX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.K252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsO&M Halyard, Inc.

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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