UTB BLUE POWDER FREE NITRILE— 510(k) K121506

Substantially Equivalent

Northstar Healthcare Holdings

FDA 510(k) clearance K121506 for UTB BLUE POWDER FREE NITRILE, Substantially Equivalent on 2012-07-03. Applicant: Northstar Healthcare Holdings.

Clearance details

Applicant: Northstar Healthcare Holdings
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2012-05-21
Decision date: 2012-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamilton, Bermuda, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZA

product code LZA

Other: 1
Total: 1

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.