POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES— 510(k) K110297

Substantially Equivalent

Comfort Rubber Gloves Industries Sdn. Bhd.

FDA 510(k) clearance K110297 for POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES, Substantially Equivalent on 2011-06-15. Applicant: 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: 2011-02-01
Decision date: 2011-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Matang, 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.