Cleared Special

Cardinal Health Nitrile Exam Gloves

K241780 · Cardinal Health200, LLC · General Hospital
Aug 2024
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K241780 is an FDA 510(k) clearance for the Cardinal Health Nitrile Exam Gloves, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on August 23, 2024, 64 days after receiving the submission on June 20, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K241780 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2024
Decision Date August 23, 2024
Days to Decision 64 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement

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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