Cleared Traditional

Medical surgical mask (Black mask, Level 1 and Level 3) (K213450) - FDA 510(k) Clearance

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

K213450 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · General Hospital
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Apr 2022
Decision
161d
Days
Class 2
Risk

K213450 is an FDA 510(k) clearance for the Medical surgical mask (Black mask, Level 1 and Level 3). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Guangdong Kingfa Sci. & Tech.Co., Ltd. (Qingyuan City, CN). The FDA issued a Cleared decision on April 5, 2022 after a review of 161 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 Guangdong Kingfa Sci. & Tech.Co., Ltd. devices

Submission Details

510(k) Number K213450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2021
Decision Date April 05, 2022
Days to Decision 161 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
32d slower than avg
Panel avg: 129d · This submission: 161d
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 404
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K213450.
Comfort Guard Mask, level 1, Comfort Guard Mask, level 3
K210860 · Gri-Alleset, Inc. · Apr 2022
Dong Hai Xiang Surgical Mask
K212203 · Taizhou Donghaixiang Protective Equipment Co., Ltd. · Apr 2022
Disposable Medical Mask
K214085 · Hubei Wanli Protective Products Co., Ltd. · Apr 2022
Medical Face Mask
K213736 · Hangzhou Runheng Medical Co., Ltd. · Mar 2022
INTAI Surgical Mask (non-sterile)
K210422 · Intai Technology Corp. · Mar 2022
Medical Surgical Mask (Model: JM92, JM92B)
K220187 · Guangdong Jia Mei Biological Technology Co.Ltd · Mar 2022