POWDER FREE NITRILE EXAMINATION GLOVES— 510(k) K111328

Substantially Equivalent

Gx Corporation Sdn Bhd

FDA 510(k) clearance K111328 for POWDER FREE NITRILE EXAMINATION GLOVES, Substantially Equivalent on 2011-07-15. Applicant: Gx Corporation Sdn Bhd.

Clearance details

Applicant: Gx Corporation Sdn Bhd
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2011-05-11
Decision date: 2011-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Klang, Selangor, 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.