Surgical Face Masks (Ear Loops And Tie-On)— 510(k) K221534

Substantially Equivalent

San-M Package Co., Ltd.

FDA 510(k) clearance K221534 for Surgical Face Masks (Ear Loops And Tie-On), Substantially Equivalent on 2022-09-16. Applicant: San-M Package Co., Ltd..

Clearance details

Applicant: San-M Package Co., Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2022-05-27
Decision date: 2022-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shimada-City, JP

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.