Disposable Medical Nitrile Examination Gloves (Non sterile)— 510(k) K212639

Name: FDA 510(k) clearance K212639
Creator: U.S. Food and Drug Administration
Published: 2021-12-08

Substantially Equivalent

Jiangsu Nanfang Medical Co., Ltd.

FDA 510(k) clearance K212639 for Disposable Medical Nitrile Examination Gloves (Non sterile), Substantially Equivalent on 2021-12-08. Applicant: Jiangsu Nanfang Medical Co., Ltd.. Device class: 1.

Clearance details

Applicant: Jiangsu Nanfang Medical Co., Ltd.
Product code: Code LZC
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2021-08-20
Decision date: 2021-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, CN

Download summary PDF View on FDA.gov ↗

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