Cleared Traditional

Disposable Surgical Face Mask (M663BE, M663BT)

K220550 · Makrite Industries, Inc. · General Hospital
Jun 2022
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K220550 is an FDA 510(k) clearance for the Disposable Surgical Face Mask (M663BE, M663BT), 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 June 14, 2022, 109 days after receiving the submission on February 25, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K220550 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2022
Decision Date June 14, 2022
Days to Decision 109 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