Surgical Face Masks (Ear loops and Tie-on)— 510(k) K160269

Substantially Equivalent

San-M Package Co., Ltd.

FDA 510(k) clearance K160269 for Surgical Face Masks (Ear loops and Tie-on), Substantially Equivalent on 2016-09-06. 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: 2016-02-02
Decision date: 2016-09-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Shimada-City, JP

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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.