POWDER-FREE NITRILE GLOVES, BLACK— 510(k) K100369

Substantially Equivalent

Hl Rubber Industries Sdn Bhd

FDA 510(k) clearance K100369 for POWDER-FREE NITRILE GLOVES, BLACK, Substantially Equivalent on 2010-05-20. Applicant: Hl Rubber Industries Sdn Bhd.

Clearance details

Applicant: Hl Rubber Industries Sdn Bhd
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2010-02-12
Decision date: 2010-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kuala Pilah, Negeri Sembilan, MY

Download summary PDF View on FDA.gov ↗

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.