DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR— 510(k) K021546

Substantially Equivalent

Creative Contract (M) Sdn Bhd

FDA 510(k) clearance K021546 for DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR, Substantially Equivalent on 2003-03-05. Applicant: Creative Contract (M) Sdn Bhd.

Clearance details

Applicant: Creative Contract (M) Sdn Bhd
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2002-05-10
Decision date: 2003-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sand Springs, OK, 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.