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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K252505
Device Name Powder-Free Vinyl Exam Gloves, clear
Applicant
Basic Medical Technology, Inc.
5300 Concours St.
Ontario,  CA  91764
Applicant Contact John Zhao
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/08/2025
Decision Date 08/28/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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