POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue)— 510(k) K150340

Substantially Equivalent

Hebei Hongsen Plastics Technology Co, Ltd.

FDA 510(k) clearance K150340 for POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue), Substantially Equivalent on 2015-06-18. Applicant: Hebei Hongsen Plastics Technology Co, Ltd..

Clearance details

Applicant: Hebei Hongsen Plastics Technology Co, Ltd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2015-02-11
Decision date: 2015-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nangong City, CN

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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.