POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY)— 510(k) K060724

Substantially Equivalent

Smart Glove Corp. Sdn Bhd

FDA 510(k) clearance K060724 for POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY), Substantially Equivalent on 2006-05-17. Applicant: Smart Glove Corp. Sdn Bhd.

Clearance details

Applicant: Smart Glove Corp. Sdn Bhd
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2006-03-17
Decision date: 2006-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Selangor Darul Eshan, 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.