NITRILE EXAMINATION GLOVES - POWDER FREE— 510(k) K980511

Substantially Equivalent

Influx Pacific Sdn. Bhd.

FDA 510(k) clearance K980511 for NITRILE EXAMINATION GLOVES - POWDER FREE, Substantially Equivalent on 1998-03-13. Applicant: Influx Pacific Sdn. Bhd..

Clearance details

Applicant: Influx Pacific Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 1998-02-10
Decision date: 1998-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malacca, West Malaysia, 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.