Cleared Traditional

K252534 - Surgical Face Mask (Ear mount) (FDA 510(k) Clearance)

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

K252534 · Zhejiang Hangkang Medical Equipment Co., Ltd. · General Hospital
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Mar 2026
Decision
203d
Days
Class 2
Risk

K252534 is an FDA 510(k) clearance for the Surgical Face Mask (Ear mount). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Zhejiang Hangkang Medical Equipment Co., Ltd. (Yiwu, CN). The FDA issued a Cleared decision on March 3, 2026 after a review of 203 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 Zhejiang Hangkang Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K252534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2025
Decision Date March 03, 2026
Days to Decision 203 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 128d · This submission: 203d
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

Shanghai SUNGO Management Consulting Co., Ltd.
Ariel Xiang

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 606
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K252534.
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K253398 · Efofex, Inc. · Feb 2026
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K243342 · Kp Trading Co., Ltd. · Dec 2025
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
K252941 · O&M Halyard, Inc. · Dec 2025