Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)— 510(k) K211827

Substantially Equivalent

Zhejiang Lanhine Medical Products, Ltd.

FDA 510(k) clearance K211827 for Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F), Substantially Equivalent on 2021-09-23. 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: 2021-09-23
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.