Cleared Abbreviated

Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles

K243172 · O&M Halyard, Inc. · General Hospital
Jun 2025
Decision
261d
Days
Class 1
Risk

About This 510(k) Submission

K243172 is an FDA 510(k) clearance for the Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by O&M Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on June 18, 2025, 261 days after receiving the submission on September 30, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K243172 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2024
Decision Date June 18, 2025
Days to Decision 261 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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