Disposable Vinyl Examination Gloves— 510(k) K223008

Name: FDA 510(k) clearance K223008
Creator: U.S. Food and Drug Administration
Published: 2022-10-08

Substantially Equivalent

Jiangxi Handspro Products Solutions Co., Ltd.

FDA 510(k) clearance K223008 for Disposable Vinyl Examination Gloves, Substantially Equivalent on 2022-10-08. Applicant: Jiangxi Handspro Products Solutions Co., Ltd.. Device class: 1.

Clearance details

Applicant: Jiangxi Handspro Products Solutions Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2022-09-29
Decision date: 2022-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiujiang City, CN

Download summary PDF View on FDA.gov ↗

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