Medical PVC Examination Gloves— 510(k) K210821

Name: FDA 510(k) clearance K210821
Creator: U.S. Food and Drug Administration
Published: 2021-07-09

Substantially Equivalent

Jiangxi Hongda Medical Equipment Group , Ltd.

FDA 510(k) clearance K210821 for Medical PVC Examination Gloves, Substantially Equivalent on 2021-07-09. Applicant: Jiangxi Hongda Medical Equipment Group , Ltd.. Device class: 1.

Clearance details

Applicant: Jiangxi Hongda Medical Equipment Group , Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2021-03-19
Decision date: 2021-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanchang, CN

Download summary PDF View on FDA.gov ↗

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