POWDER-FREE VINYL EXAM GLOVES— 510(k) K091772

Name: FDA 510(k) clearance K091772
Creator: U.S. Food and Drug Administration
Published: 2010-04-08

Substantially Equivalent

Shijiazhuang Huijingyuan Plastic Co, Ltd.

FDA 510(k) clearance K091772 for POWDER-FREE VINYL EXAM GLOVES, Substantially Equivalent on 2010-04-08. Applicant: Shijiazhuang Huijingyuan Plastic Co, Ltd.. Device class: 1.

Clearance details

Applicant: Shijiazhuang Huijingyuan Plastic Co, Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2009-06-16
Decision date: 2010-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwood Village, CO, US

Download summary PDF View on FDA.gov ↗

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