Cleared Traditional

Disposable Surgical Mask/Fluid Resistant Procedure Mask (K202240) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202240 · Lhm Medical Technology (Hong Kong) Limited · General Hospital
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Feb 2021
Decision
199d
Days
Class 2
Risk

K202240 is an FDA 510(k) clearance for the Disposable Surgical Mask/Fluid Resistant Procedure Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Lhm Medical Technology (Hong Kong) Limited (Hongkong, CN). The FDA issued a Cleared decision on February 25, 2021 after a review of 199 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Lhm Medical Technology (Hong Kong) Limited devices

Submission Details

510(k) Number K202240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2020
Decision Date February 25, 2021
Days to Decision 199 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 129d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FXX Mask, Surgical

All 405
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K202240.
Medical mask (Model: KKF-1A)
K202316 · Han Zhaoqing Sporting Goods Company Limited · Mar 2021
Surgical Mask-Model Number: Ear Loop, Flat-Pleated
K201852 · Huizhou Foryou Medical Devices Co., Ltd. · Mar 2021
IFM Surgical Mask Model SM3
K202214 · Fssc, LLC · Mar 2021
Surgical Masks
K203524 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Feb 2021
Phyziofit Medical Surgical Mask
K201868 · Wellpower Sporting Goods Co., Ltd. · Feb 2021
iMask Disposable Surgical Face Mask
K201182 · Pac-Dent, Inc. · Feb 2021