Vinyl Examination Gloves(Yellow)— 510(k) K203666

Name: FDA 510(k) clearance K203666
Creator: U.S. Food and Drug Administration
Published: 2021-03-12

Substantially Equivalent

Lutai Medical Technology Co., Ltd.

FDA 510(k) clearance K203666 for Vinyl Examination Gloves(Yellow), Substantially Equivalent on 2021-03-12. Applicant: Lutai Medical Technology Co., Ltd.. Device class: 1.

Clearance details

Applicant: Lutai Medical Technology Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2020-12-16
Decision date: 2021-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dezhou, CN

Download summary PDF View on FDA.gov ↗

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