BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES— 510(k) K081972

Substantially Equivalent

Nitritex (M) Sdn. Bhd.

FDA 510(k) clearance K081972 for BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES, Substantially Equivalent on 2008-12-11. Applicant: Nitritex (M) Sdn. Bhd..

Clearance details

Applicant: Nitritex (M) Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2008-07-10
Decision date: 2008-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kuala Langat, Selangor De, 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.