Nitrile Powder Free Examination Glove (Blue)— 510(k) K142588

Substantially Equivalent

Hartalega Sdn Bhd

FDA 510(k) clearance K142588 for Nitrile Powder Free Examination Glove (Blue), Substantially Equivalent on 2014-12-18. Applicant: Hartalega Sdn Bhd.

Clearance details

Applicant: Hartalega Sdn Bhd
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2014-09-15
Decision date: 2014-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bandar Sri Damansara, 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.