WHITE PLUME SURGICAL GAUZE FACE MASK— 510(k) K870312

Substantially Equivalent

China National Medicines & Health Prod. I/E Corp.

FDA 510(k) clearance K870312 for WHITE PLUME SURGICAL GAUZE FACE MASK, Substantially Equivalent on 1987-02-24. Applicant: China National Medicines & Health Prod. I/E Corp..

Clearance details

Applicant: China National Medicines & Health Prod. I/E Corp.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1987-01-28
Decision date: 1987-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suite 500, Washington, DC, 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.