Medline Surgical Face Mask and Medline Procedural Face Mask— 510(k) K223236

Substantially Equivalent

Medline Industries, LP

FDA 510(k) clearance K223236 for Medline Surgical Face Mask and Medline Procedural Face Mask, Substantially Equivalent on 2023-03-24. Applicant: Medline Industries, LP.

Clearance details

Applicant: Medline Industries, LP
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2022-10-19
Decision date: 2023-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northfiled, IL, 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.