Cleared Abbreviated

Fusion Black Powder-Free Nitrile Exam Glove

K150113 · Halyard Health · General Hospital
Jun 2015
Decision
149d
Days
Class 1
Risk

About This 510(k) Submission

K150113 is an FDA 510(k) clearance for the Fusion Black Powder-Free Nitrile Exam Glove, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Halyard Health (Roswell, US). The FDA issued a Cleared decision on June 18, 2015, 149 days after receiving the submission on January 20, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K150113 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2015
Decision Date June 18, 2015
Days to Decision 149 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LZA — Polymer Patient Examination Glove
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.

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