POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)— 510(k) K091147

Substantially Equivalent

Smart Glove Corp. Sdn Bhd

FDA 510(k) clearance K091147 for POWDER FREE NITRILE EXAMINATION GLOVE (BLUE), Substantially Equivalent on 2009-07-27. Applicant: Smart Glove Corp. Sdn Bhd.

Clearance details

Applicant: Smart Glove Corp. Sdn Bhd
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2009-04-20
Decision date: 2009-07-27
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.