Cross Protection ResQ300 Plus Surgical Face Mask— 510(k) K212273

Substantially Equivalent

Cross Protection (M) Sdn Bhd

FDA 510(k) clearance K212273 for Cross Protection ResQ300 Plus Surgical Face Mask, Substantially Equivalent on 2022-08-17. Applicant: Cross Protection (M) Sdn Bhd.

Clearance details

Applicant: Cross Protection (M) Sdn Bhd
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-07-20
Decision date: 2022-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Klang, MY

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.