Cleared Traditional

Disposable Medical Masks

K221038 · Hantech Medical Device Co., Ltd. · General Hospital
Sep 2022
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K221038 is an FDA 510(k) clearance for the Disposable Medical Masks, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Hantech Medical Device Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on September 1, 2022, 147 days after receiving the submission on April 7, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K221038 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2022
Decision Date September 01, 2022
Days to Decision 147 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

Similar Devices — FXX Mask, Surgical

All 605
Surgical Face Mask (Ear mount)
K252534 · Zhejiang Hangkang Medical Equipment Co., Ltd. · Mar 2026
Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
K253398 · Efofex, Inc. · Feb 2026
Disposable Surgical Face Mask (3P00B, C2900)
K252830 · Beatles Medical Supplies (Xiantao) Co., Ltd. · Jan 2026
Disposable Medical Face Mask
K252650 · Makrite Industries, Inc. · Jan 2026
KP Protective Face Mask
K243342 · Kp Trading Co., Ltd. · Dec 2025
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
K252941 · O&M Halyard, Inc. · Dec 2025