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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 K212847
Device Name Penta Glove
Applicant
Pentavest Holdings Sdn Bhd
No. 9574-9578, Jalan PTB 2 , Kawasan Perindustrian Tangga,
Batu,  MY 76400
Applicant Contact Teng Boon Joo
Correspondent
Liberty Management Group Ltd.
75 Executive Dr. STE 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/07/2021
Decision Date 01/06/2022
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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