Cleared Traditional

KP Protective Face Mask

K243342 · Kp Trading Co., Ltd. · General Hospital

Dec 2025

Decision

423d

Days

Class 2

Risk

About This 510(k) Submission

K243342 is an FDA 510(k) clearance for the KP Protective Face Mask, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Kp Trading Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on December 22, 2025, 423 days after receiving the submission on October 25, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K243342 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 25, 2024
Decision Date	December 22, 2025
Days to Decision	423 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF