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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 K253824
Device Name Powder Free Nitrile Examination Gloves Non-Sterile Black
Applicant
Kanglongda Vietnam Protection Technology Company Limited
Lot Cn 05, Viglacera - Phong Dien Industrial Park
Phong Dinh Ward
Hue City,  VN 530000
Applicant Contact Thamira Ranasinghe
Correspondent
Kanglongda Vietnam Protection Technology Company Limited
Lot Cn 05, Viglacera - Phong Dien Industrial Park
Phong Dinh Ward
Hue City,  VN 530000
Correspondent Contact Thamira Ranasinghe
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/01/2025
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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