POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE)— 510(k) K050531

Substantially Equivalent

Spi Gloves Sdn. Bhd.

FDA 510(k) clearance K050531 for POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE), Substantially Equivalent on 2005-03-18. Applicant: Spi Gloves Sdn. Bhd..

Clearance details

Applicant: Spi Gloves Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2005-03-02
Decision date: 2005-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ipoh 30450, 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.