POWDER-FREE VINYL PATIENT EXAMINATION GLOVES— 510(k) K083015

Name: FDA 510(k) clearance K083015
Creator: U.S. Food and Drug Administration
Published: 2009-03-10

Substantially Equivalent

Zibo Goldenline Plastic Product Co., Ltd.

FDA 510(k) clearance K083015 for POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, Substantially Equivalent on 2009-03-10. Applicant: Zibo Goldenline Plastic Product Co., Ltd.. Device class: 1.

Clearance details

Applicant: Zibo Goldenline Plastic Product Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2008-10-09
Decision date: 2009-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chino, CA, US

Download summary PDF View on FDA.gov ↗

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