Surgical Mask (sterile)— 510(k) K211295

Substantially Equivalent

Nanjing 3h Medical Products Co., Ltd.

FDA 510(k) clearance K211295 for Surgical Mask (sterile), Substantially Equivalent on 2021-11-24. Applicant: Nanjing 3h Medical Products Co., Ltd..

Clearance details

Applicant: Nanjing 3h Medical Products Co., Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-04-28
Decision date: 2021-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, 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.