Sterile Latex Powder-Free Surgical Gloves— 510(k) K191898

Name: FDA 510(k) clearance K191898
Creator: U.S. Food and Drug Administration
Published: 2019-12-18

Substantially Equivalent

Modern Healthcare Corp.

FDA 510(k) clearance K191898 for Sterile Latex Powder-Free Surgical Gloves, Substantially Equivalent on 2019-12-18. Applicant: Modern Healthcare Corp.. Device class: 1.

Clearance details

Applicant: Modern Healthcare Corp.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2019-07-16
Decision date: 2019-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chang-Hwa, TW

Download summary PDF View on FDA.gov ↗

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