POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES— 510(k) K083624

Substantially Equivalent

Comfort Rubber Gloves Ind. Sdn. Bhd.

FDA 510(k) clearance K083624 for POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES, Substantially Equivalent on 2009-02-10. Applicant: Comfort Rubber Gloves Ind. Sdn. Bhd..

Clearance details

Applicant: Comfort Rubber Gloves Ind. Sdn. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2008-12-08
Decision date: 2009-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taiping, Perak, 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.