POWDERED NITRILE EXAMINATION GLOVES— 510(k) K980149

Substantially Equivalent

Masju Sdn. Bhd.

FDA 510(k) clearance K980149 for POWDERED NITRILE EXAMINATION GLOVES, Substantially Equivalent on 1998-01-29. Applicant: Masju Sdn. Bhd..

Clearance details

Applicant: Masju Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 1998-01-16
Decision date: 1998-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sungai Petani, 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.