Cleared Traditional

Disposable Medical Face Mask

K252650 · Makrite Industries, Inc. · General Hospital
Jan 2026
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K252650 is an FDA 510(k) clearance for the Disposable Medical Face Mask, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Makrite Industries, Inc. (New Taipei, TW). The FDA issued a Cleared decision on January 5, 2026, 136 days after receiving the submission on August 22, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K252650 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2025
Decision Date January 05, 2026
Days to Decision 136 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FXX — Mask, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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