Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue— 510(k) K153028

Name: FDA 510(k) clearance K153028
Creator: U.S. Food and Drug Administration
Published: 2016-02-05

Substantially Equivalent

Zibo Huiying Medical Products, Co. , Ltd.

FDA 510(k) clearance K153028 for Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue, Substantially Equivalent on 2016-02-05. Applicant: Zibo Huiying Medical Products, Co. , Ltd.. Device class: 1.

Clearance details

Applicant: Zibo Huiying Medical Products, Co. , Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2015-10-16
Decision date: 2016-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Linzi, CN

Download summary PDF View on FDA.gov ↗

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