FDA 510(k)

KP Protective Face Mask

K-Number: K243342 · 2025-12-22

Decision Date2025-12-22

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

KP Protective Face Mask is a medical device manufactured by Kp Trading Co., Ltd.. It received FDA 510(k) clearance on 2025-12-22 under approval number K243342. 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 KP Protective Face Mask?

KP Protective Face Mask is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by Kp Trading Co., Ltd.. The 510(k) number is K243342.

When was KP Protective Face Mask approved by the FDA?

KP Protective Face Mask received FDA 510(k) clearance on 2025-12-22, under approval number K243342.

What company makes KP Protective Face Mask?

KP Protective Face Mask is manufactured by Kp Trading Co., Ltd..

What is the FDA product code for KP Protective Face Mask?

The FDA product code for KP Protective Face Mask is FXX.

Related Devices (Code: FXX)

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Official Source

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