Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove— 510(k) K190159

Name: FDA 510(k) clearance K190159
Creator: U.S. Food and Drug Administration
Published: 2019-05-06

Substantially Equivalent

Showa Best Glove, Inc.

FDA 510(k) clearance K190159 for Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove, Substantially Equivalent on 2019-05-06. Applicant: Showa Best Glove, Inc.. Device class: 1.

Clearance details

Applicant: Showa Best Glove, Inc.
Product code: Code LZC
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2019-01-30
Decision date: 2019-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo, GA, US

Download summary PDF View on FDA.gov ↗

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