Cleared Traditional

Medical Face Mask (K213736) - FDA 510(k) Clearance

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

K213736 · Hangzhou Runheng Medical Co., Ltd. · General Hospital
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Mar 2022
Decision
122d
Days
Class 2
Risk

K213736 is an FDA 510(k) clearance for the Medical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Hangzhou Runheng Medical Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on March 31, 2022 after a review of 122 days - within the typical 510(k) review window.

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 Hangzhou Runheng Medical Co., Ltd. devices

Submission Details

510(k) Number K213736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2021
Decision Date March 31, 2022
Days to Decision 122 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
7d faster than avg
Panel avg: 129d · This submission: 122d
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 K213736.
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 surgical mask (Black mask, Level 1 and Level 3)
K213450 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Apr 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
3 Ply Medical Grade Single Use Procedural Disposable Face Mask
K220637 · Kdi Med Supply · Mar 2022