SURGICAL FACE MASK (Ear Loops and Tie-on)— 510(k) K133070

Substantially Equivalent

Bh Medical Products Co., Ltd.

FDA 510(k) clearance K133070 for SURGICAL FACE MASK (Ear Loops and Tie-on), Substantially Equivalent on 2015-06-22. Applicant: Bh Medical Products Co., Ltd..

Clearance details

Applicant: Bh Medical Products Co., Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2013-09-30
Decision date: 2015-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, DE, 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.