WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD— 510(k) K023755

Substantially Equivalent

Winner Industries (Shenzhen) Co., Ltd.

FDA 510(k) clearance K023755 for WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD, Substantially Equivalent on 2003-06-10. Applicant: Winner Industries (Shenzhen) Co., Ltd..

Clearance details

Applicant: Winner Industries (Shenzhen) Co., Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2002-11-08
Decision date: 2003-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, CA, 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.