BLUE POWDERED NITRILE EXAMINATION GLOVE— 510(k) K122998

Substantially Equivalent

Northstar Healthcare Holdings

FDA 510(k) clearance K122998 for BLUE POWDERED NITRILE EXAMINATION GLOVE, Substantially Equivalent on 2012-11-06. Applicant: Northstar Healthcare Holdings.

Clearance details

Applicant: Northstar Healthcare Holdings
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2012-09-27
Decision date: 2012-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mc Henry, IL, US

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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.