NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)— 510(k) K140610

Substantially Equivalent

Hartalega NGC Sdn. Bhd.

FDA 510(k) clearance K140610 for NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU), Substantially Equivalent on 2014-06-20. Applicant: Hartalega NGC Sdn. Bhd..

Clearance details

Applicant: Hartalega NGC Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2014-03-10
Decision date: 2014-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bandar Sri Damansara, 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.