Vinyl Exam Gloves— 510(k) K213019

Name: FDA 510(k) clearance K213019
Creator: U.S. Food and Drug Administration
Published: 2022-01-05

Substantially Equivalent

Hebei Astro Medical Supply Co., Ltd.

FDA 510(k) clearance K213019 for Vinyl Exam Gloves, Substantially Equivalent on 2022-01-05. Applicant: Hebei Astro Medical Supply Co., Ltd.. Device class: 1.

Clearance details

Applicant: Hebei Astro Medical Supply Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2021-09-20
Decision date: 2022-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jinzhou, CN

Download summary PDF View on FDA.gov ↗

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