Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))— 510(k) K203418

Substantially Equivalent

Ningbo Ouhan Medical Device Co., Ltd.

FDA 510(k) clearance K203418 for Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)), Substantially Equivalent on 2021-09-17. Applicant: Ningbo Ouhan Medical Device Co., Ltd..

Clearance details

Applicant: Ningbo Ouhan Medical Device Co., Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-11-19
Decision date: 2021-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yuyao City, CN

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.