Disposable Surgical Face Mask (M663BE, M663BT)— 510(k) K220550

Substantially Equivalent

Makrite Industries, Inc.

FDA 510(k) clearance K220550 for Disposable Surgical Face Mask (M663BE, M663BT), Substantially Equivalent on 2022-06-14. Applicant: Makrite Industries, Inc..

Clearance details

Applicant: Makrite Industries, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2022-02-25
Decision date: 2022-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei, TW

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.