KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS— 510(k) K110455

Substantially Equivalent

Kimberly-Clark Corp.

FDA 510(k) clearance K110455 for KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS, Substantially Equivalent on 2011-04-29. Applicant: Kimberly-Clark Corp..

Clearance details

Applicant: Kimberly-Clark Corp.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2011-02-15
Decision date: 2011-04-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Roswell, GA, US

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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.