POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN)— 510(k) K050530

Substantially Equivalent

Spi Gloves Sdn. Bhd.

FDA 510(k) clearance K050530 for POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN), Substantially Equivalent on 2005-03-16. 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: 2005-03-16
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.