KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL— 510(k) K111402

Substantially Equivalent

Kimberly-Clark

FDA 510(k) clearance K111402 for KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL, Substantially Equivalent on 2011-10-20. Applicant: Kimberly-Clark.

Clearance details

Applicant: Kimberly-Clark
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2011-05-19
Decision date: 2011-10-20
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.