Cleared Traditional

Disposable Medical Face Mask (M643BE)

K240258 · Makrite Industries, Inc. · General Hospital
Apr 2024
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K240258 is an FDA 510(k) clearance for the Disposable Medical Face Mask (M643BE), 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 April 18, 2024, 78 days after receiving the submission on January 31, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K240258 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2024
Decision Date April 18, 2024
Days to Decision 78 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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