RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)— 510(k) K133193

Substantially Equivalent

Riverstone Resources Sdn Bhd

FDA 510(k) clearance K133193 for RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE), Substantially Equivalent on 2014-06-23. Applicant: Riverstone Resources Sdn Bhd.

Clearance details

Applicant: Riverstone Resources Sdn Bhd
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2013-10-17
Decision date: 2014-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 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.