Cleared Traditional

Medline Surgical Face Mask and Medline Procedural Face Mask

K223236 · Medline Industries, LP · General Hospital
Mar 2023
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K223236 is an FDA 510(k) clearance for the Medline Surgical Face Mask and Medline Procedural Face Mask, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Medline Industries, LP (Nortfield, US). The FDA issued a Cleared decision on March 24, 2023, 156 days after receiving the submission on October 19, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K223236 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 2022
Decision Date March 24, 2023
Days to Decision 156 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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