Cleared Traditional

Surgical Face Masks (Ear Loops And Tie-On)

K221534 · San-M Package Co., Ltd. · General Hospital
Sep 2022
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K221534 is an FDA 510(k) clearance for the Surgical Face Masks (Ear Loops And Tie-On), a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by San-M Package Co., Ltd. (Shimada-City, JP). The FDA issued a Cleared decision on September 16, 2022, 112 days after receiving the submission on May 27, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K221534 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2022
Decision Date September 16, 2022
Days to Decision 112 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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