POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM— 510(k) K102189

Substantially Equivalent

Latexx Manufacturing Sdn.Bhd.

FDA 510(k) clearance K102189 for POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM, Substantially Equivalent on 2012-03-14. Applicant: Latexx Manufacturing Sdn.Bhd..

Clearance details

Applicant: Latexx Manufacturing Sdn.Bhd.
Product code: Code LZC
Advisory panel: General Hospital
Date received: 2010-08-02
Decision date: 2012-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheat Ridge, CO, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.