Powder Free Grey Vinyl Examination Gloves— 510(k) K161072

Name: FDA 510(k) clearance K161072
Creator: U.S. Food and Drug Administration
Published: 2016-07-14

Substantially Equivalent

Zibo Flourish Trading Co., Ltd.

FDA 510(k) clearance K161072 for Powder Free Grey Vinyl Examination Gloves, Substantially Equivalent on 2016-07-14. Applicant: Zibo Flourish Trading Co., Ltd.. Device class: 1.

Clearance details

Applicant: Zibo Flourish Trading Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2016-04-18
Decision date: 2016-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zibo, CN

Download summary PDF View on FDA.gov ↗

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