NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)— 510(k) K063046

Substantially Equivalent

Hartalega Sdn Bhd

FDA 510(k) clearance K063046 for NITRILE POWDER FREE EXAMINATION GLOVES (GREEN), Substantially Equivalent on 2006-11-17. Applicant: Hartalega Sdn Bhd.

Clearance details

Applicant: Hartalega Sdn Bhd
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2006-10-04
Decision date: 2006-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bestari Jaya, MY

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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.