Synthetic Vinyl Examination Gloves— 510(k) K212002

Name: FDA 510(k) clearance K212002
Creator: U.S. Food and Drug Administration
Published: 2021-09-23

Substantially Equivalent

Yunnan Huazhiyuan Medical Technology Co., Ltd.

FDA 510(k) clearance K212002 for Synthetic Vinyl Examination Gloves, Substantially Equivalent on 2021-09-23. Applicant: Yunnan Huazhiyuan Medical Technology Co., Ltd.. Device class: 1.

Clearance details

Applicant: Yunnan Huazhiyuan Medical Technology Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2021-06-28
Decision date: 2021-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Honghe Hani And Yi Autonomous Prefecture, CN

Download summary PDF View on FDA.gov ↗

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