R&G Surgical Mask— 510(k) K232112

Substantially Equivalent

R&G Seguridad E Higiene Industrial S.A.C.

FDA 510(k) clearance K232112 for R&G Surgical Mask, Substantially Equivalent on 2024-04-02. Applicant: R&G Seguridad E Higiene Industrial S.A.C..

Clearance details

Applicant: R&G Seguridad E Higiene Industrial S.A.C.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2023-07-14
Decision date: 2024-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Callao, PE

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.