Cleared Traditional

Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask (K211462) - FDA 510(k) Clearance

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

K211462 · Xiantao S&J Protective Products Co., Ltd. · General Hospital
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Aug 2021
Decision
100d
Days
Class 2
Risk

K211462 is an FDA 510(k) clearance for the Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Xiantao S&J Protective Products Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on August 19, 2021 after a review of 100 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 Xiantao S&J Protective Products Co., Ltd. devices

Submission Details

510(k) Number K211462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2021
Decision Date August 19, 2021
Days to Decision 100 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
29d faster than avg
Panel avg: 129d · This submission: 100d
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

Mid-Link Consulting Co, Ltd.
Diana Hong

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 K211462.
CiRx (R) Surgical Mask
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WYZ Surgical Mask
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Surgical mask
K211454 · Jiangsu Xingtong Biotechnology Group Co., Ltd. · Aug 2021
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