Cleared Abbreviated

Powder-Free Nitrile Examination Gloves

K223214 · Global Protection Corp. · General Hospital
Sep 2023
Decision
339d
Days
Class 1
Risk

About This 510(k) Submission

K223214 is an FDA 510(k) clearance for the Powder-Free Nitrile Examination Gloves, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Global Protection Corp. (Boston, US). The FDA issued a Cleared decision on September 21, 2023, 339 days after receiving the submission on October 17, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K223214 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2022
Decision Date September 21, 2023
Days to Decision 339 days
Submission Type Abbreviated
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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