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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 K232319
Device Name Black Pearl Nitrile Examination Glove
Applicant
UG Global Resources Sdn. Bhd.
Lot 62 & 63, Lorong Senawang 3/2,
Kawasan Perindustrian Senawang,
Seremban,  MY 70450
Applicant Contact Lee Mei Ling
Correspondent
UG Global Resources Sdn. Bhd.
Lot 62 & 63, Lorong Senawang 3/2,
Kawasan Perindustrian Senawang,
Seremban,  MY 70450
Correspondent Contact Lee Mei Ling
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/03/2023
Decision Date 04/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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