Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask— 510(k) K211832

Substantially Equivalent

Zhejiang Lanhine Medical Products, Ltd.

FDA 510(k) clearance K211832 for Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask, Substantially Equivalent on 2021-09-08. Applicant: Zhejiang Lanhine Medical Products, Ltd..

Clearance details

Applicant: Zhejiang Lanhine Medical Products, Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-06-14
Decision date: 2021-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cixi, 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.