Disposable Surgical Mask/Fluid Resistant Procedure Mask— 510(k) K202240

Substantially Equivalent

Lhm Medical Technology (Hong Kong) Limited

FDA 510(k) clearance K202240 for Disposable Surgical Mask/Fluid Resistant Procedure Mask, Substantially Equivalent on 2021-02-25. Applicant: Lhm Medical Technology (Hong Kong) Limited.

Clearance details

Applicant: Lhm Medical Technology (Hong Kong) Limited
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-08-10
Decision date: 2021-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hongkong, CN

Download summary PDF View on FDA.gov ↗

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.