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FDA 510(k)

KP Protective Face Mask

K-Number: K243342 · 2025-12-22

ApplicantKp Trading Co., Ltd.
Decision Date2025-12-22
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KP Protective Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Kp Trading Co., Ltd.. It received FDA 510(k) clearance on 2025-12-22 under 510(k) 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. The listed applicant is Kp Trading Co., Ltd.. The 510(k) number is K243342.

When did KP Protective Face Mask receive FDA 510(k) clearance?

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

Who is the listed applicant for KP Protective Face Mask?

The FDA 510(k) record lists Kp Trading Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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)

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.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.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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