Surgical Face Mask (Ear mount)— 510(k) K252534

Name: FDA 510(k) clearance K252534
Creator: U.S. Food and Drug Administration
Published: 2026-03-03

Substantially Equivalent

Zhejiang Hangkang Medical Equipment Co., Ltd.

FDA 510(k) clearance K252534 for Surgical Face Mask (Ear mount), Substantially Equivalent on 2026-03-03. Applicant: Zhejiang Hangkang Medical Equipment Co., Ltd.. Device class: 2.

Clearance details

Applicant: Zhejiang Hangkang Medical Equipment Co., Ltd.
Product code: Code FXX
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2025-08-12
Decision date: 2026-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yiwu, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FXX

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Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.