Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)— 510(k) K182043

Name: FDA 510(k) clearance K182043
Creator: U.S. Food and Drug Administration
Published: 2018-09-21

Substantially Equivalent

Hebei Titans Hongsen Medical Technology Co., Ltd.

FDA 510(k) clearance K182043 for Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored), Substantially Equivalent on 2018-09-21. Applicant: Hebei Titans Hongsen Medical Technology Co., Ltd.. Device class: 1.

Clearance details

Applicant: Hebei Titans Hongsen Medical Technology Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2018-07-30
Decision date: 2018-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nangong, CN

Download summary PDF View on FDA.gov ↗

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