3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask— 510(k) K191355

Substantially Equivalent

3M Healthcare

FDA 510(k) clearance K191355 for 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask, Substantially Equivalent on 2019-09-11. Applicant: 3M Healthcare.

Clearance details

Applicant: 3M Healthcare
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2019-05-21
Decision date: 2019-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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.