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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K252075
Device Name Program insite® Powder-Free, Disposable Nitrile Exam Gloves
Applicant
Program Insite, LLC
2224 Victoria Pl.
Olney,  MD  20832
Applicant Contact Emnet Menyahil
Correspondent
Program Insite, LLC
2224 Victoria Pl.
Olney,  MD  20832
Correspondent Contact Emnet Menyahil
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/02/2025
Decision Date 10/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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