Vinyl Examination Gloves— 510(k) K213625

Name: FDA 510(k) clearance K213625
Creator: U.S. Food and Drug Administration
Published: 2022-02-17

Substantially Equivalent

Dezhou Hengchang Medical Technology Co., Ltd.

FDA 510(k) clearance K213625 for Vinyl Examination Gloves, Substantially Equivalent on 2022-02-17. Applicant: Dezhou Hengchang Medical Technology Co., Ltd.. Device class: 1.

Clearance details

Applicant: Dezhou Hengchang Medical Technology Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2021-11-17
Decision date: 2022-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dezhou City, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.