Disposable Medical Face Mask (ear loop)— 510(k) K221196

Substantially Equivalent

Xiantao Topmed Nonwoven Protective Products Co., Ltd.

FDA 510(k) clearance K221196 for Disposable Medical Face Mask (ear loop), Substantially Equivalent on 2022-07-22. Applicant: Xiantao Topmed Nonwoven Protective Products Co., Ltd..

Clearance details

Applicant: Xiantao Topmed Nonwoven Protective Products Co., Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2022-04-25
Decision date: 2022-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiantao, 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.