POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR— 510(k) K051317

Substantially Equivalent

Platinum Glove Industries Sdn. Bhd.

FDA 510(k) clearance K051317 for POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR, Substantially Equivalent on 2005-06-20. Applicant: Platinum Glove Industries Sdn. Bhd..

Clearance details

Applicant: Platinum Glove Industries Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2005-05-20
Decision date: 2005-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kuala Lumpur, 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.