NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS— 510(k) K091652

Substantially Equivalent

Hartalega Sdn Bhd

FDA 510(k) clearance K091652 for NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS, Substantially Equivalent on 2009-09-04. Applicant: Hartalega Sdn Bhd.

Clearance details

Applicant: Hartalega Sdn Bhd
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2009-06-09
Decision date: 2009-09-04
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.