Cleared Traditional

Surgical Masks (K212807) - FDA 510(k) Clearance

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

K212807 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · General Hospital
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Dec 2021
Decision
91d
Days
Class 2
Risk

K212807 is an FDA 510(k) clearance for the Surgical Masks. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. (Weihai, CN). The FDA issued a Cleared decision on December 3, 2021 after a review of 91 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 Weihai Hongyu Nonwoven Fabric Products Co., Ltd. devices

Submission Details

510(k) Number K212807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2021
Decision Date December 03, 2021
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
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 Consultant

Beijing Believe-Med Technology Service Co., Ltd.
Ray Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FXX Mask, Surgical

All 404
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K212807.
BAYLAB 3-Ply Surgical Mask (BEACON I)
K212302 · Baylab USA, LLC · Dec 2021
PMW01 Procedure Mask Level 1
K211772 · Defender Safety, Inc. · Dec 2021
Surgical Face Mask
K212235 · Shanghai Yunqing Industrial Co., Ltd. · Dec 2021
Single-use Surgical Mask
K211773 · Taiwan Seafood and Fish Corporation · Dec 2021
Puravita Medical Fold Flat Surgical Mask
K212740 · Puravita M, LLC · Dec 2021
Disposable Surgical Face Mask
K211696 · Anhui Cleanpro Pharmpack Co., Ltd. · Nov 2021