Vinyl Patient Examination Gloves— 510(k) K182117

Name: FDA 510(k) clearance K182117
Creator: U.S. Food and Drug Administration
Published: 2018-10-06

Substantially Equivalent

Jiangxi Zhonghong Pulin Medical Products Co., Ltd.

FDA 510(k) clearance K182117 for Vinyl Patient Examination Gloves, Substantially Equivalent on 2018-10-06. Applicant: Jiangxi Zhonghong Pulin Medical Products Co., Ltd.. Device class: 1.

Clearance details

Applicant: Jiangxi Zhonghong Pulin Medical Products Co., Ltd.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2018-08-06
Decision date: 2018-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiu Jiang, CN

Download summary PDF View on FDA.gov ↗

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