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FDA 510(k)

Surgical Face Mask (Ear mount)

K-Number: K252534 · 2026-03-03

ApplicantZhejiang Hangkang Medical Equipment Co., Ltd.
Decision Date2026-03-03
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Face Mask (Ear mount) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Hangkang Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K252534. 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 Surgical Face Mask (Ear mount)?

Surgical Face Mask (Ear mount) is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is Zhejiang Hangkang Medical Equipment Co., Ltd.. The 510(k) number is K252534.

When did Surgical Face Mask (Ear mount) receive FDA 510(k) clearance?

Surgical Face Mask (Ear mount) received FDA 510(k) clearance on 2026-03-03, under 510(k) number K252534.

Who is the listed applicant for Surgical Face Mask (Ear mount)?

The FDA 510(k) record lists Zhejiang Hangkang Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Face Mask (Ear mount)?

The FDA product code for Surgical Face Mask (Ear mount) is FXX.

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.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.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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