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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K212848
Device Name Sterile Latex Surgical Gloves Powder Free
Applicant
Pentavest Holdings Sdn Bhd
# 9574-9578, Jalan Ptb 2 , Kawasan Perindustrian Tangga,
Batu,  MY 76400
Applicant Contact Teng Boon Joo
Correspondent
Liberty Management Group , Ltd.
75 Executive Dr. Ste114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number878.4460
Classification Product Code
KGO  
Date Received09/07/2021
Decision Date 12/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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