Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)— 510(k) K163168

Name: FDA 510(k) clearance K163168
Creator: U.S. Food and Drug Administration
Published: 2017-02-23

Substantially Equivalent

Hebei Hongtai Plastic Products Company Limited

FDA 510(k) clearance K163168 for Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow), Substantially Equivalent on 2017-02-23. Applicant: Hebei Hongtai Plastic Products Company Limited. Device class: 1.

Clearance details

Applicant: Hebei Hongtai Plastic Products Company Limited
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2016-11-14
Decision date: 2017-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xingtai, CN

Download summary PDF View on FDA.gov ↗

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