KC 300 SURGICAL MASK— 510(k) K131879

Substantially Equivalent

Kimberly-Clark Corp.

FDA 510(k) clearance K131879 for KC 300 SURGICAL MASK, Substantially Equivalent on 2013-12-20. Applicant: Kimberly-Clark Corp..

Clearance details

Applicant: Kimberly-Clark Corp.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2013-06-24
Decision date: 2013-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roswell, GA, 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.