GLOBAL HEALTHCARE FACE MASK— 510(k) K953754

Substantially Equivalent

Global Healthcare, Inc.

FDA 510(k) clearance K953754 for GLOBAL HEALTHCARE FACE MASK, Substantially Equivalent on 1996-01-26. Applicant: Global Healthcare, Inc..

Clearance details

Applicant: Global Healthcare, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1995-08-11
Decision date: 1996-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, 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.