NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK— 510(k) K151836

Substantially Equivalent

Hartalega NGC Sdn. Bhd.

FDA 510(k) clearance K151836 for NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK, Substantially Equivalent on 2015-10-21. Applicant: Hartalega NGC Sdn. Bhd..

Clearance details

Applicant: Hartalega NGC Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2015-07-06
Decision date: 2015-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sepang, MY

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.