Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)— 510(k) K222266

Substantially Equivalent

Jingzhou Haixin Green Cross Medical Products Co., Ltd.

FDA 510(k) clearance K222266 for Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80), Substantially Equivalent on 2022-09-26. Applicant: Jingzhou Haixin Green Cross Medical Products Co., Ltd..

Clearance details

Applicant: Jingzhou Haixin Green Cross Medical Products Co., Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2022-07-28
Decision date: 2022-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jingzhou, 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.