NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM— 510(k) K112976

Substantially Equivalent

Hartalega Snd. Bhd.

FDA 510(k) clearance K112976 for NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM, Substantially Equivalent on 2012-02-02. Applicant: Hartalega Snd. Bhd..

Clearance details

Applicant: Hartalega Snd. Bhd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2011-10-06
Decision date: 2012-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bestari Jaya, 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.