Private Stock Labs Surgical Face Mask— 510(k) K211425

Substantially Equivalent

J.K. Private Stock, Inc.

FDA 510(k) clearance K211425 for Private Stock Labs Surgical Face Mask, Substantially Equivalent on 2021-10-04. Applicant: J.K. Private Stock, Inc..

Clearance details

Applicant: J.K. Private Stock, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-05-07
Decision date: 2021-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fresh Meadows, NY, US

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.