510(k) K240269— Nitrile Powder Free Examination Gloves Biodegradable (Green)

Substantially Equivalent

Comfort Rubber Gloves Industries Sdn. Bhd.

Clearance details

Applicant: Comfort Rubber Gloves Industries Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2024-01-31
Decision date: 2024-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Matang, MY

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.