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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 a medical device manufactured by Zhejiang Hangkang Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-03-03 under approval 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. It is manufactured by Zhejiang Hangkang Medical Equipment Co., Ltd.. The 510(k) number is K252534.

When was Surgical Face Mask (Ear mount) approved by the FDA?

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

What company makes Surgical Face Mask (Ear mount)?

Surgical Face Mask (Ear mount) is manufactured by Zhejiang Hangkang Medical Equipment Co., Ltd..

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

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

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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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