Cleared Abbreviated

Program insite? Powder-Free, Disposable Nitrile Exam Gloves

K252075 · Program Insite, LLC · General Hospital
Oct 2025
Decision
107d
Days
Class 1
Risk

About This 510(k) Submission

K252075 is an FDA 510(k) clearance for the Program insite? Powder-Free, Disposable Nitrile Exam Gloves, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Program Insite, LLC (Olney, US). The FDA issued a Cleared decision on October 17, 2025, 107 days after receiving the submission on July 2, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K252075 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2025
Decision Date October 17, 2025
Days to Decision 107 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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